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Намерени 3,079 изпитвания Стр. 139 от 154

Активно (без набиране) Фаза 3

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

Haemophilia A With Inhibitors Haemophilia B With Inhibitors

This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group, participants will get study medicine from the start of the study. In the other group, participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will get 1 injection with the study medicine every day under the skin. This participants will have to do themselves and can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about seven years. The length of time the participants will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (31 December 2026 at the latest). The time between visits will be approximately 4 weeks for the first 6 to 12 months, depending on the group participants are in and approximately 8 weeks for the rest of the study. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.

Начало: 21.10.2019 Край: 21.02.2027 Лечение

Algeria, Australia, Bulgaria +24 Novo Nordisk A/S NCT04083781

Активно (без набиране) Фаза 3

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.

Начало: 18.10.2019 Край: 20.05.2027 Възраст: 10–18 г. Лечение

Argentina, Australia, Belgium +18 Biogen NCT03958877

Активно (без набиране) Фаза 2

Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors

Metastatic Solid Tumor

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with metastatic (cancer that has spread) solid tumors.

Начало: 15.10.2019 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +5 Gilead Sciences NCT03964727

Активно (без набиране) Фаза 1

ENABLE-1 (Engaging Toll-like Receptor Signalling for B-cell Lymphoma Chimeric Antigen Receptor Therapy)

Lymphomas Non-Hodgkin's B-Cell Diffuse Large B-cell Lymphoma (DLBCL) Primary Mediastinal B-cell Lymphoma (PMBCL) Transformed Follicular Lymphoma (TFL) +2

This Phase 1, single centre, open label dose escalation study aims to identify a safe dose of third-generation anti-CD19 CAR T-cells (WZTL-002) in the treatment of patients with relapsed or refractory (r/r) B-cell Non Hodgkin Lymphoma, for use in further efficacy trials. An expansion cohort will assess automated closed-system manufacture of WZTL-002 and outpatient management of participants.

Начало: 11.10.2019 Край: 01.03.2029 Възраст: 16–75 г. Лечение

New Zealand Malaghan Institute of Medical Research NCT04049513

Активно (без набиране) Фаза 2

Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

Cutaneous Squamous Cell Carcinoma Advanced Cutaneous Squamous Cell Carcinoma Metastatic Cutaneous Squamous Cell Carcinoma

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

Начало: 08.10.2019 Край: 01.09.2025 Възраст: от 18 г. Лечение

Australia, Bulgaria, Canada +7 Replimune, Inc. NCT04050436

Активно (без набиране) Фаза 2

Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Multiple Myeloma

B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.

Начало: 07.10.2019 Край: 11.03.2027 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +12 GlaxoSmithKline NCT04126200

Активно (без набиране) Фаза 3

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

HER2-positive Breast Cancer

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

Начало: 02.10.2019 Край: 10.03.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +14 Seagen, a wholly owned subsidiary of Pfizer NCT03975647

Активно (без набиране) Фаза 3

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Начало: 30.09.2019 Край: 09.07.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +22 Bristol-Myers Squibb NCT04039607

Активно (без набиране) Фаза 2/3

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Начало: 26.09.2019 Край: 29.09.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +29 Janssen Research & Development, LLC NCT04033445

Активно (без набиране) Фаза 1

Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer

Breast Neoplasm Female

This study is investigating the combination of palbociclib, letrozole and venetoclax in ER and BCL-2 positive locally advanced or metastatic breast cancer. It is hypothesised that venetoclax may augment the actions of palbociclib and letrozole in these patient groups. The primary objective of the study is to determine the maximum tolerated dose of the combination treatment, which can be used in subsequent studies. The study will also investigate disease response and survival. Participants will receive palbociclib (daily, on days 1-21 of each 28 day cycle), letrozole (daily, on days 1-28 of each 28 day cycle) and venetoclax (daily, on days 1-21 of each 28 day cycle) until the last patient has completed 18 months treatment on the study.

Начало: 25.09.2019 Край: 01.12.2025 Възраст: от 18 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT03900884

Активно (без набиране) Фаза 3

Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy

Diabetic Cardiomyopathies

This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.

Начало: 20.09.2019 Край: 01.12.2025 Възраст: от 40 г. Лечение

Australia, Canada, Czechia +7 Applied Therapeutics, Inc. NCT04083339

Активно (без набиране) Фаза 4

Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy

Dementia, Mixed Dementia, Vascular Dementia of Alzheimer Type Cognitive Decline +3

The STAREE-Mind imaging sub-study will examine the effect of statin treatment over a 4-year period, compared with placebo, on markers of brain health.

Начало: 19.09.2019 Край: 01.09.2026 Възраст: от 70 г. Превенция

Australia Monash University NCT05586750

Активно (без набиране)

Arrhythmia Burden, Risk of Sudden Cardiac Death and Stroke in Patients With Fabry Disease

Fabry Disease

Fabry disease (FD) is a genetic disorder that leads to progressive accumulation of fat or 'sphingolipid' within the tissues, including the heart muscle and conductive tissue. Improvements in the detection of FD, together with more organised clinical services for rare diseases, has led to a rapid growth in the disease prevalence. Earlier and more frequent diagnosis of asymptomatic individuals before development of the disease itself has focused attention on early detection of organ involvement and closer monitoring of disease progression. Moreover, the introduction of enzyme replacement therapy within the last two decades has changed the natural history of FD as follows: a) increased life expectancy; b) improved morbidity; c) modification of the main cause of morbidity and mortality from renal (kidney) to cardiovascular (heart) events, including heart failure, abnormal heart rhythms, stroke and sudden death. Although symptoms such as palpitations and blackouts are extremely common, information on the frequency of proven abnormal heart rhythms is limited. In addition, the rate and appropriateness of implantation of life-saving devices is very variable, including pacemakers to boost the heart when too slow and cardio-defibrillators that stop the heart when too fast. The main markers of risk in similar diseases such as hypertrophic cardiomyopathy cannot be used in FD. While patients are routinely followed up in clinic with heart tracings and echocardiography (ultrasound of the heart), a recent small study has emphasised that these tests under-estimate the burden of abnormal heart rhythms in patients with advanced FD. The use of continuous heart monitoring with an implantable loop recorder (ILR) has led to a significant change in treatment in 13 out of 15 of FD patients. The investigators believe that more frequent use of ILRs will identify a greater need for change in therapy in many more patients than currently treated, with the aim of reducing morbidity and mortality in this patient cohort. In addition this will provide valuable data to inform an estimate of future risk for these patients.

Начало: 18.09.2019 Край: 01.07.2027 Възраст: от 18 г. Диагностика

Australia, United Kingdom University Hospital Birmingham NHS Foundation Trust NCT03305250

Активно (без набиране)

Portico Next Generation Approval Study

Symptomatic Severe Aortic Stenosis

The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to support CE (Conformité Européenne) Mark and FDA approval.

Начало: 17.09.2019 Край: 01.12.2027 Възраст: 18–100 г. Лечение

Australia, Denmark, Italy +2 Abbott Medical Devices NCT04011722

Активно (без набиране) Фаза 1/2

COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC

Metastatic Microsatellite-stable Colorectal Cancer

COLUMBIA-1 is a Phase 1b/2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX plus bevacizumab) alone and in combination with novel oncology therapies in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC).

Начало: 13.09.2019 Край: 24.11.2026 Възраст: 18–101 г. Лечение

Australia, Canada, France +2 MedImmune LLC NCT04068610

Активно (без набиране) Фаза 3

An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

Chronic Lymphocytic Leukemia Acute Myeloid Leukemia Multiple Myeloma Non-Hodgkin's Lymphoma +2

The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.

Начало: 06.09.2019 Край: 01.08.2027 Лечение

Australia, Belgium, Canada +18 AbbVie NCT03844048

Активно (без набиране) Фаза 3

An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 \[NCT03945188\] or APD334-302 \[NCT03996369\] or APD334-210 \[NCT04607837\]).

Начало: 05.09.2019 Край: 19.06.2029 Възраст: 16–80 г. Лечение

Argentina, Australia, Belarus +32 Pfizer NCT03950232

Активно (без набиране) Фаза 3

A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.

Начало: 20.08.2019 Край: 01.12.2027 Възраст: от 60 г. Лечение

Australia, Belgium, Canada +17 BeiGene NCT04002297

Активно (без набиране) Фаза 1/2

Study of Lenalidomide, Venetoclax and Obinutuzumab in Patients With Treatment-Naïve Follicular Lymphoma

Follicular Lymphoma

The trial will investigate the combination of venetoclax, obinutuzumab and lenalidomide in patients with treatment-naïve follicular lymphoma. Patients will receive induction treatment for 0.5 years with venetoclax, obinutuzumab and lenalidomide followed by maintenance treatment for upto 2 years. Maintenance treatment will be determined by the response at the end of induction. Following completion of treatment patients will be followed up for 3 years after the last patient completes induction treatment.

Начало: 19.08.2019 Край: 01.11.2026 Възраст: от 18 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT03980171

Активно (без набиране)

Observational Evaluation of Atopic Dermatitis in Pediatric Patients

Dermatitis Atopic

Primary Objectives: * To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable. * To evaluate the time-course of AD and selected atopic comorbidities. Secondary Objectives: * To characterize disease burden and unmet need. * To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching). * To document the real-world effectiveness and safety of treatments.

Начало: 15.08.2019 Край: 23.07.2035 Възраст: до 11 г.

Argentina, Australia, Brazil +17 Sanofi NCT03687359

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