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Намерени 4,436 изпитвания Стр. 7 от 222

Набира участници Фаза 1

A Phase I study to evaluate the safety and dosimetry of imaging with 68Ga-OncoACP3 in prostate cancer.

Patients with prostate cancer with: - suspected metastasis who are candidates for initial definitive therapy - suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e. a progressive and confirmed serum PSA level > 0.2 ng/mL) - metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands

Trial status: Authorised

Начало: 22.04.2026 Възраст: от 18 г.

Italy Philogen S.p.A. 2025-524594-16-00

Набира участници

Clinical Evaluation of Different Treatments for Interdental Black Triangles

Black Triangles Syndrome (BTS) Papilla Reconstruction

This randomized clinical trial aims to evaluate and compare the effectiveness of surgical and nonsurgical treatment approaches for the management of interdental black triangles. Black triangles are open gingival embrasures caused by the loss or deficiency of the interdental papilla between adjacent teeth. These spaces are a common esthetic concern and may also contribute to food impaction and periodontal problems. Thirty adult patients presenting with interdental papillary loss classified as Nordland and Tarnow Class I or II will be recruited from the outpatient clinics of the Faculty of Dentistry at King Salman International University. Eligible participants will be randomly assigned to one of three treatment groups: surgical reconstruction using the tube grafting technique, papillary augmentation using hyaluronic acid injection, or a restorative approach using the injection molding composite technique. Clinical and photographic assessments will be performed at baseline and during follow-up visits at 3 and 6 months after treatment. The primary outcomes will be the reduction in black triangle surface area and height. Secondary outcomes will include clinical periodontal parameters such as plaque index, bleeding score, probing pocket depth, and clinical attachment level. Patient satisfaction with the esthetic outcome will also be evaluated using a Visual Analog Scale (VAS). The findings of this study are expected to provide evidence regarding the comparative effectiveness of surgical and nonsurgical approaches for the management of interdental black triangles and help clinicians select the most predictable treatment modality for improving esthetic outcomes.

Начало: 22.04.2026 Край: 15.10.2026 Възраст: 18–50 г.

Egypt Ain Shams University NCT07548203

Набира участници Фаза 2

COLOMBE - A multicentre, single arm, phase 1/2 study, aiming to assess the safety and efficacy of nivolumab and imiquimod combination in vulvar squamous cell carcinoma patients

Vulvar Squamous Cell Carcinoma (VSCC) patients

Trial status: Authorised Pathological response: The pathological tumor response (pTR) is defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (

Начало: 22.04.2026 Възраст: от 18 г.

France Centre Leon Berard 2025-524759-29-00

Набира участници Фаза 2

Exploratory study on the effect of Rimonabant on hand function in patients with spinal cord injury (RIMOHANDOPEN)

Spinal cord injury

Trial status: Authorised 6-Minute Walk Test (6MWT): measures the distance a participant can walk in six minutes, providing an index to measure fatigue, endurance and functional walking capacity, 10-Meter Walk Test (10MWT): measures the time taken to walk 10 meters at a comfortable or maximal pace, used to assess motor function through walking speed, fatigue and endurance, Berg Balance Scale (BBS): evaluates static and dynamic balance through 14 functional tasks, providing a quantitative assessment of fall risk and postural control, Walking Index for Spinal Cord Injury II (WISCI-II): assesses walking ability based on the level of assistance, use of assistive devices and need for support, yielding a score reflecting functional ambulation capacity., Finger Tapping Test (FTT): measures motor speed and coordination by recording the number of finger taps within a set time period, Box and Block Test (BBT): assesses gross manual dexterity by counting the number of blocks transferred from one compartment to another in 60 seconds, Nine-Hole Peg Test (9HPT): measures fine manual dexterity by timing how long it takes to place and remove nine pegs from a boardNine-Hole Peg Test (9HPT): measures fine manual dexterity by timing how long it takes to place and remove nine pegs from a board, Dynamometry: measures handgrip strength by recording the maximum force exerted during a grip using a handheld dynamometer., Upper Extremity Motor Score (UEMS): evaluates motor strength of five key upper limb muscles bilaterally. This data is obtained from the ISNCSCI scale, Functional Reach Test (FRT): assesses upper limb functional reach and dynamic balance by measuring the maximum distance an individual can reach forward without losing stability, Borg CR10 Scale: assesses perceived exertional fatigue immediately after the 6MWT and FTT, providing a subjective measure of effort intensity, Visual Analogue Scale for Fatigue (VAS-F): assesses perceived fatigue intensity by having participants rate their level of fatigue after FTT, Fatigue Severity Scale (FSS): evaluates fatigue severity over the previous week. Scores ≥ 4 indicate clinically significant fatigue, Multidimensional Fatigue Inventory (MFI-20): measures five dimensions of fatigue, offering a comprehensive assessment of fatigue impact, Breathing test: test designed to evaluate the respiratory function and lung capacity of the participant., Oximetry: non-invasively measures blood oxygen saturation and heart rate, providing a quick indicator of the participant's respiratory status, Heart rate: non-invasive measurement used to monitor cardiovascular response and detect potential abnormalities in heart function., Blood pressure (systolic and diastolic): non-invasive assessment providing key information on vascular resistance and overall cardiovascular health., International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI): determines the neurological level and completeness of spinal cord injury through systematic assessment of motor and sensory function, Transcranial magnetic stimulation (TMS): evaluate corticospinal excitability and motor pathway integrity registering motor evoked potentials (MEPs)., Somatosensory evoked potentials (SEPs) via electrical stimulation: assess sensory pathway conduction and integrity by recording cortical responses to peripheral nerve electrical stimulation., Spinal Cord Independence Measure (SCIM-III): measures functional independence in activities of daily living, mobility, and sphincter management, providing an index of overall functional recovery., Medical Outcomes Study Sleep Scale (MOS-SS): assesses multiple aspects of sleep, including quality, disturbances, somnolence, and adequacy, over the previous four weeks., Patient Global Impression of Change (PGIC): captures the patient’s subjective perception of overall improvement or deterioration since the beginning of the study., Recording and assessment of adverse events (AEs) occurring during treatment, serious adverse events (SAEs), and adverse events of special interest (AESIs)., Clinically significant changes in physical examination, biochemical parameters, vital signs., Clinically significant changes in subjective pain perception, assessed using the Visual Analogue Scale (VAS-P)., Clinically significant changes in the level of muscle spasticity, assessed using the Modified Ashworth Scale (MAS)., Clinically significant changes in the frequency of muscle spasms, assessed using the Penn Spasm Frequency Scale (PSFS)., Clinically significant changes in mood, specifically depression and anxiety, assessed using the Beck Depression Inventory-II (BDI-II) and the Hospital Anxiety and Depression Scale (HADS)., Suicide risk, assessed using C-SSRS. The primary endpoint is defined as the change in the total GRASSP score, or in any of its three dimensions, between baseline and the end of rimonabant treatment.

Начало: 22.04.2026 Възраст: от 18 г.

Spain Sinfatin S.L. 2025-524279-22-00

Набира участници Фаза 1

A FIRST-IN-HUMAN (FIH) PHASE 1/2 STUDY TO ASSESS SAFETY, TOLERABILITY, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF REGN17372, AN ANTI-GPRC5D X ANTI-CD28 COSTIMULATORY BISPECIFIC MONOCLONAL ANTIBODY, IN COMBINATION WITH LINVOSELTAMAB, AN ANTI-BCMA X ANTI-CD3 BISPECIFIC MONOCLONAL ANTIBODY, IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Relapsed/Refractory Multiple Myeloma

Trial status: Authorised Phase 1 and Phase 2: Concentrations of REGN17372 in serum, Phase 1 and Phase 2: Concentrations of linvoseltamab in serum, Phase 1 and Phase 2: Occurrence of Anti-Drug Antibodies (ADA) to REGN17372, Phase 1 and Phase 2: Magnitude of ADA to REGN17372, Phase 1 and Phase 2: Incidence of ADA to linvoseltamab, Phase 1 and Phase 2: Magnitude of ADA to linvoseltamab, Phase 1 and Phase 2: Objective Response Rate (ORR) as assessed by IMWG response criteria as determined by the investigator, Phase 1 and Phase 2: Complete response (CR) as assessed by IMWG response criteria as determined by the investigator, Phase 1 and Phase 2: VGPR as assessed by IMWG response criteria, as determined by the investigator, Phase 1 and Phase 2: Duration of Response (DOR) as assessed by IMWG criteria as determined by the investigator, Phase 1 and Phase 2: Progression Free Survival (PFS) as assessed by IMWG criteria as determined by the investigator, Phase 1 and Phase 2: Minimal Residual Disease (MRD) negative status (at 10^-5) in participants in CR or better, Phase 1 and Phase 2: Overall Survival (OS), Phase 1: ORR as assessed using the IMWG response criteria as determined by the investigator in patients receiving combination study drugs, Phase 1:VGPR assessed using IMWG criteria as determined by the investigator in patients receiving combination study drugs, Phase 2: Incidence of TEAEs, Phase 2: Severity of TEAEs, Phase 2: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Global Health Status / Quality of Life (GHS/QoL), Phase 2: Change from baseline in EORTC QLQ-C30 Physical Functioning (PF), Phase 2: Change from baseline in EORTC QLQ-C30 Role Functioning (RF), Phase 2: Change from baseline in EORTC QLQ-C30 pain, Phase 2: Change from baseline in EORTC QLQ-C30 fatigue, Phase 2: Time to definitive deterioration in EORTC QLQ-C30 GHS/QoL, Phase 2: Time to definitive deterioration in EORTC QLQ-C30 PF, Phase 2: Time to definitive deterioration in EORTC QLQ-C30 RF, Phase 2: Time to definitive deterioration in EORTC QLQ-C30 pain, Phase 2: Time to definitive deterioration in EORTC QLQ-C30 fatigue, Phase 2: Time to first improvement in EORTC QLQ-C30 GHS/QoL, Phase 2: Time to first improvement in EORTC QLQ-C30 PF, Phase 2: Time to first improvement in EORTC QLQ-C30 RF, Phase 2: Time to first improvement in EORTC QLQ-C30 pain, Phase 2: Time to first improvement in EORTC QLQ-C30 fatigue, Phase 2: Change from baseline in EORTC QLQ-Multiple Myeloma Module (MY20) Disease Symptoms (DS), Phase 2: Time to definitive deterioration in EORTC QLQ-MY20 DS, Phase 2: Time to first improvement in EORTC QLQ-MY20 DS, Phase 2: Change from baseline in EORTC QLQ-MY20 Treatment Side Effects (TSE), Phase 2: Time to definitive deterioration in EORTC QLQ-MY20 TSE, Phase 2: Time to first improvement in EORTC QLQ-MY20 TSE, Phase 2: Change from baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS), Phase 2: Time to definitive deterioration in EQ-5D-5L VAS, Phase 2: Time to first improvement in EQ-5D-5L VAS, Phase 2: Patient-reported overall impact of treatment toxicity measured by Functional Assessment of Cancer Therapy (FACIT) Item GP5, Phase 2: Patient-reported tolerability as measured by the Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Phase 1: Occurrence of Dose Limiting Toxicities (DLTs) from the first dose of REGN17372 in combination with linvoseltamab, Phase 1: Occurrence of Treatment Emergent Adverse Events (TEAEs) associated with REGN17372 in combination with linvoseltamab, Phase 1: Severity of TEAEs associated with REGN17372 in combination with linvoseltamab, Phase 2: Very Good Partial Response (VGPR) or better as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria in patients receiving combination study drugs, Phase 2: VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy, Phase 2: Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination study drugs, Phase 2: PR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy

Начало: 22.04.2026 Възраст: от 18 г.

Greece Regeneron Pharmaceuticals Inc. 2025-522776-93-00

Набира участници Фаза 2

A Multicentre, Parallel-group, Phase II, Randomised, Double-blind, 4 Arm Study to Evaluate Efficacy and Safety of AZD1163 in Participants with Moderately-to-Severely Active Rheumatoid Arthritis (LaunchPAD-RA)

Rheumatoid arthritis

Trial status: Authorised Percentage of Participants Achieving American College of Rheumatology Response Criteria 20 (ACR20) at Week 12 - Percentage of Participants Achieving ACR50 at Week 12 - Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12 - Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12, AZD1163 concentrations in serum., ADA (incidence, prevalence, and titres) Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12

Начало: 22.04.2026 Възраст: от 18 г.

Germany, Hungary, Poland +1 AstraZeneca AB 2025-522076-85-00

Набира участници Фаза 2

ROSETTA HCC-206: An Open-Label, Multi-Center, Randomized Phase 1/2 Study of Pumitamig Alone or In Combination with Ipilimumab in Participants with First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC)

Advanced or unresectable Hepatocellular Carcinoma (HCC)

Trial status: Authorised To check how many people’s liver cancer gets much smaller or goes away (cancer shrinkage)., To count how many people have problems or serious problems from the medicines, including those who stop treatment or die because of them (safety), To measure how much pumitamig is in the blood after treatment and before the next dose (pumitamig levels)., To measure how much ipilimumab is in the blood before the next dose (ipilimumab levels)., To see if people’s bodies make fighters against the medicines (anti-drug antibodies)., To see how long people live without the cancer getting worse, and how long the cancer stays smaller or goes away (progression delay (PFS, Progression-Free Survival and duration (DOR, Duration of Response). The main goal of phase 1 will check and count for how many people have problems or serious problems from the medicine, if anyone must stop taking it because of these problems, and if any problems cause death., The main goal of phase 2 will be to check and count how many people's liver cancer gets much smaller or completely goes away with the treatment (OR (Objective Response) confirmed CR (complete response) or PR (partial response)).

Начало: 22.04.2026 Възраст: от 18 г.

Italy, Poland Bristol-Myers Squibb Services Unlimited Company 2025-523602-33-00

Набира участници Фаза 2

A phase II trial evaluating treatment intensification with Ezabenlimab in patients with PD-L1–expressing, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) with minimal residual disease (MRD) as detected by circulating tumor DNA (ctDNA) after curative-intent chemoradiation

Locally advanced head and neck squamous cell carcinoma (LA-HNSCC)

Trial status: Authorised Frequency and severity of TEAEs, irAEs, IRRs, serious AEs (SAE) TEAE/SAEs leading to dose delays, withdrawal or death. Clinically significant changes in laboratory, vital signs, and safety assessment parameters., Change from baseline in QoL as assessed by the EORTC QLQ-C30 and QLQ-HN43. Participant-reported frequency and severity of symptomatic toxicity based on PRO-CTCAE and FACT-GP5 and frequency distribution of PGIS/PGIC over time., Correlation of post-CRT ctDNA-based MRD status, ctDNA longitudinal changes (such as molecular response) with clinical activity and response. Change of ctDNA status (approx. every 3 months)., OS defined as the time from post-CRT MRD assessment to death from any cause., EFS is defined as the time from post-CRT MRD assessment to disease progression, recurrence, or death from any cause, whichever comes first EFS rate at 2-years in MRD-positive patients (interventional cohort) where EFS rate is defined as the proportion of patients who have not experienced any EFS event at 2 years after MRD assessment (i.e., after CRT).

Начало: 22.04.2026 Възраст: от 18 г.

Belgium Cliniques Universitaires Saint-Luc 2025-523575-36-00

Набира участници Фаза 2

Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

Myocardial Infarction Reperfusion Injury AMI STEMI (ST Elevation MI)

This study is open to adults with ST elevation myocardial infarction (heart attack) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study is to determine whether a medicine called Xolatryp is safe and effective in improving cardiac outcomes. One dose of Xolatryp will be tested in this study. Participants are put into two groups randomly, which means by chance. One group receives a single 6-hour continuous intravenous infusion of Xolatryp and one group receives placebo. Participants are in the study for about 30 days. Placebo infusion looks like Xolatryp but do not contain any medicine. Participants are followed up via telephone and there is one visit to the study site on day 30. Heart health is assessed based on the analysis of blood samples, which are collected at the study site, via electrocardiogram (ECG), echocardiogram and cardiac magnetic resonance (CMR) imaging. At the end of the study, the results are compared between the two groups. During the study, the doctors also regularly check the general health of the participants.

Начало: 22.04.2026 Край: 30.09.2027 Възраст: 40–75 г. Лечение

Australia Nyrada Pty Ltd NCT07362446

Набира участници Фаза 2

A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive Aromatase Inhibitor Therapy, AIMSS-RPS Trial

Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 +1

This phase II trial tests the safety and effectiveness of a dietary supplement called resistant potato starch for reducing musculoskeletal symptoms in patients with stage 0-III breast cancer or who are at high risk for breast cancer and are planning to receive treatment with an aromatase inhibitor. Aromatase inhibitors are a type of drug commonly used for the treatment or prevention of breast cancer. Many people who receive aromatase inhibitors experience musculoskeletal symptoms (symptoms relating to bones and muscles, such as joint pain or stiffness). Research has shown there may be an association between reduced levels of beneficial gut bacteria and the development of aromatase inhibitor-associated musculoskeletal symptoms. Resistant potato starch is a plant-based low-digestible carbohydrate that has the potential to promote the growth of beneficial gut bacteria. Taking resistant potato starch while receiving aromatase inhibitor therapy may reduce musculoskeletal symptoms in patients with stage 0-III breast cancer or individuals at high risk of developing breast cancer.

Начало: 22.04.2026 Край: 01.04.2028

United States University of Michigan Rogel Cancer Center NCT07443943

Набира участници

Trial of Underwater Birth

Birth

Evaluate maternal perinatal outcomes in adult low-risk laboring people randomized to waterbirth compared to those randomized to birth on land.

Начало: 21.04.2026 Край: 01.12.2028 Възраст: от 18 г.

United States University of New Mexico NCT07313319

Набира участници Фаза 1

A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)

Diabetic Macular Edema

The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.

Начало: 21.04.2026 Край: 17.11.2028 Възраст: от 18 г.

United States Genentech, Inc. NCT07425522

Набира участници Фаза 4

A research study to compare blood levels of cagrilintide after multiple doses of different versions of cagrilintide in adults with overweight or obesity

obesity

Trial status: Authorised

Начало: 21.04.2026 Възраст: 18–64 г.

Germany Novo Nordisk A/S 2025-521384-12-00

Набира участници Фаза 3

J3R-MC-YDAL - A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Persistent Obesity or Overweight Treated With a Weekly Incretin, With and Without Type 2 Diabetes

Overweight Obesity

Trial status: Authorised Percent Change from Baseline in Body Weight [Time Frame: Baseline, Week 64]

Начало: 21.04.2026 Възраст: от 18 г.

Belgium, Czech Republic, Spain Eli Lilly & Co. 2025-523659-73-00

Набира участници Фаза 1

An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants with Active Sjogren’s Disease or Idiopathic Inflammatory Myopathy

Seropositive autoimmune disease: Sjogren’s disease or idiopathic inflammatory myopathy

Trial status: Authorised

Начало: 21.04.2026 Възраст: от 18 г.

Czech Republic Ouro Medicines Limited 2025-524100-29-00

Набира участници Фаза 2

Protocol Title: Efficacy and safety of once-weekly subcutaneous NNC0662-0419 in participants with type 2 diabetes – a dose-finding study

type 2 diabetes

Trial status: Authorised Relative change in body weight, Change in body weight Change in HbA1c

Начало: 21.04.2026 Възраст: 18–64 г.

Hungary, Poland, Portugal +1 Novo Nordisk A/S 2025-523260-20-00

Набира участници

Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County

HIV Prevention

This project evaluates the implementation strategy of the delivery of lenacapavir pre-exposure prophylaxis (LEN PrEP) - a newly available long-acting, injectable medication for human immunodeficiency virus (HIV) prevention - via a mobile health van model for people who are unstably housed in Los Angeles County (LAC). People who are unhoused or are facing housing instability experience significant barriers to accessing HIV prevention care in traditional clinic settings. In 2022, approximately 13% of newly diagnosed HIV cases in LAC were experiencing homelessness, a 36% increase over the prior period. The study will work with the University of California, Los Angeles (UCLA) Health's Homeless Healthcare Collaborative (HHC), which operates mobile health vans staffed by clinicians, social workers, and community health workers, to bring LEN PrEP directly to community settings, such as shelters, encampments, community centers, and transitional housing facilities. This study has three primary aims: 1. Characterize uptake of LEN PrEP among unstably housed people in LAC receiving health services via HHC's mobile program. 2. Evaluate how many study participants stay on LEN PrEP through 52 weeks. 3. Understand costs, acceptability, and sustainability of the mobile LEN PrEP delivery model.

Начало: 21.04.2026 Край: 31.12.2027 Възраст: от 18 г.

United States University of California, Los Angeles NCT07467018

Набира участници Фаза 2

NoELA_No Endocrine therapy in small HR+ HER2- low relapse risk Luminal A early breast cancer, a single-arm de-escalation trial

Postmenopausal patients with small (pT1a-b pN0) hormone receptor positive (HR⁺) and HER2 negative (HER2⁻) early breast cancer with a Luminal A phenotype and at low risk of recurrence.

Trial status: Authorised RFI of participants treated with adjuvant hormone therapy in the CANTO study, Incidence of Ipsilateral DCIS, Contralateral DCIS, Invasive contralateral breast cancer at 5, 8 and 10 years*, Distant disease free survival (DDFS) and relapse free survival (RFS) rates at 5, 8, 10 years and overall survival (OS) at 5, 10 years * (RFI, DDFS, RFS and OS defined as per standardized STEEP v2.0 criteria), EORTC QLQC30 and EORTC QLQ-BR42, HADS questionnaires, Bone-related events and osteopenia/osteoporosis diagnosis, dyslipidemia (hypercholesterolemia and hypertriglyceridemia) and cardiovascular events (myocardial infarction, stroke, and thromboembolic events), as per CTCAE v6.0. Relapse-free interval (RFI) is defined as the delay between initial treatment and the first occurrence of i) ipsilateral breast tumor recurrence, ii) distant or locoregional recurrence or iii) death from breast cancer, according to the STEEP system definition version 2.0 (Tolaney SM et al., JCO 2021)

Начало: 21.04.2026 Възраст: от 18 г.

France Unicancer 2025-523683-20-00

Набира участници Фаза 3

A Randomized, Multi-Center, Double-Blind, Phase III Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia

Chemotherapy induced thrombocytopenia

Trial status: Authorised Proportion of participants who completed two consecutive on-study chemotherapy cycles without thrombocytopenia-induced modification of any myelosuppressive agent., Proportion of participants achieving PC ≥100×109 /L without the use of rescue therapy within 14 days after initiating the IP treatment (including Day 14), Proportion of participants with at least a single incidence of rescue therapy., Time to rescue therapy free first platelet response of PC ≥100×109/L defined as the interval between the initiation of IP treatment and the first platelet response., Cumulative duration of platelet response of PC ≥100×109/L without the use of rescue therapy., PC nadir from C1D1 until C2D21 (window period: +4 days)., Cumulative duration of severe thrombocytopenia, defined as the number of consecutive days with a PC of ≤50×109/L., Proportion of participants who completed two consecutive on-study chemotherapy cycles without treatment regimen modification., Proportion of participants with all cause events leading to treatment regimen modifications including dose reduction, delay, omission, or discontinuation., Proportion of participants who are free from serious bleeding events, defined as Grade >=2 per the World Health Organization (WHO) bleeding scale, during the treatment period from the initiation of IP treatment until C2D21 (window period: +4 days)., Number and proportion of participants with adverse events (AEs)/serious adverse events (SAEs), safety laboratory parameters, vital signs, etc., Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until C2D21 (window period: +4 days)., Proportion of non-Asian treatment responders who meet the following criteria (Part A only): 1) Platelet count (PC) of 100×109/L within 14 days after initiating the IP treatment (incl. Day 14); 2) Complete two consecutive on-study chemotherapy cycles (C1 and C2) without thrombocytopenia-induced modification of any myelosuppressive agent; 3) No use of any rescue therapy for thrombocytopenia during the treatment period from initiation of IMP treatment until Day 21 of C2 (C2D21; window period:+4d) Part A: PK parameters (e.g., Cmax, AUC0-tau, Cmin) of hetrombopag in non-Asian participants with CIT., Proportion of treatment responders meeting these criteria: 1. Platelet count (PC) ≥100×109 /L within 14 days after initiating IMP treatment (incl Day 14); 2. Complete two consecutive on-study chemotherapy cycles (C1 and C2) without thrombocytopenia-induced modification of any myelosuppressive agent; 3. No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of IP treatment until Day 21 of C2 (C2D21; window period: +4 days).

Начало: 21.04.2026 Възраст: от 18 г.

France, Poland, Romania Jiangsu Hengrui Pharmaceuticals Co. Ltd. 2025-524209-34-00

Набира участници Фаза 3

A Phase III, randomized, placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy followed by an Open Label Extension

Participants with Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)

Trial status: Authorised Change from baseline at Week 72 in the PSPRS-28, Changes from baseline at Week 72 in activities of daily living on the XXX, Change from baseline at Week 72 in the Progressive Supranuclear Palsy Quality of Life scale (PSP-ShoQoL), Change from baseline at Week 72 in the Category Fluency, Phonemic Fluency, Symbol Digit Modality Test (SDMT), and Letter-Number- Sequencing (LNS), Changes from baseline in volumes of ventricles, whole brain, midbrain, pons, superior cerebellar peduncle, third ventricle, frontal lobe as measured by MRI until Week 72., Safety and tolerability parameters including AEs, AESIs, SAEs (including SAEs with fatal outcomes), AEs leading to XXX and treatment interruptions, AEs leading to dose discontinuation, clinical laboratory evaluations, vital signs, electrocardiogram (ECG), XXX Change from baseline at Week 72 in the rPSPRS-10 score

Начало: 21.04.2026 Възраст: от 18 г.

Belgium, Germany, Netherlands Novartis Pharma AG 2025-523481-24-00

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