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Набира участници Фаза 3

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

Oligometastatic Prostate Cancer (OMPC)

The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).

Начало: 12.03.2024 Край: 03.10.2031 Възраст: 18–100 г. Лечение

Argentina, Australia, Belgium +22 Novartis Pharmaceuticals NCT05939414

Набира участници Фаза 2

Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma

Merkel Cell Carcinoma

The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival

Начало: 11.03.2024 Край: 01.04.2034 Възраст: от 18 г. Лечение

Australia Melanoma Institute Australia NCT06151236

Набира участници Фаза 1

A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer

Metastatic Castration-Resistant Prostate Cancer

Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy. ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 230 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Начало: 08.03.2024 Край: 01.05.2027 Възраст: от 18 г. Лечение

Australia, Canada, France +4 AbbVie NCT06318273

Набира участници Фаза 1

A Study of MGC026 in Participants With Advanced Solid Tumors

Advanced Solid Tumor Advanced Cancer Metastatic Cancer Squamous Cell Carcinoma of Head and Neck +18

The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.

Начало: 06.03.2024 Край: 01.10.2028 Възраст: от 18 г. Лечение

Australia, United Kingdom, United States MacroGenics NCT06242470

Набира участници Фаза 2

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation. The participants will be treated with TAK-279 for 52 weeks (1 year). During the study, participants will visit their study clinic 15 times.

Начало: 05.03.2024 Край: 23.07.2027 Възраст: 18–75 г. Лечение

Australia, Belgium, Brazil +21 Takeda NCT06233461

Набира участници Фаза 4

The STOP-MED CTRCD Trial

Heart Failure Cardiotoxicity Cardiac Toxicity Antineoplastics Toxicity +1

Cancer therapy-related cardiac dysfunction (CTRCD) is when the heart's ability to pump oxygenated blood to the body is compromised. It is a side effect of cancer therapy which can occur as commonly as in 1 in 5 patients. When this occurs, heart failure medications are started to protect the heart from progressing to heart failure. With early detection and treatment, heart function recovers to normal in \>80% of patients. Unfortunately, heart failure medications are associated with an undesirable long-term pill burden, financial costs, and side-effects (e.g., dizziness and fatigue). As a result, cancer survivors frequently ask if they can safely stop their heart failure medications once their heart function has returned to normal. Currently there is no scientific evidence in this area of Cardio-Oncology. To address this knowledge gap, the investigators have designed a randomized control trial to assess the safety of stopping heart failure medication in patients with CTRCD and recovered heart function. The investigators will enrol patients who have completed their cancer therapy and are on heart medications for their CTRCD, which has now normalized. The investigators will randomize patients with no other reasons to continue heart failure medications (e.g., kidney disease) to continuing or stopping their heart medications safely. All patients will undergo a cardiac MRI at baseline, 1 and 5 years with safety assessments at 6-8 weeks, 6 months and 3 and 5 years. The investigators will determine if stopping medications is non-inferior to continuing medications by counting the numbers of patients who develop heart dysfunction by 1 year in each group.

Начало: 04.03.2024 Край: 01.12.2031 Възраст: от 18 г. Лечение

Australia, Canada, Poland +3 Dinesh Thavendiranathan NCT06183437

Набира участници Фаза 3

A Study of Sepiapterin in Participants With Phenylketonuria (PKU)

Phenylketonuria

The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood.

Начало: 04.03.2024 Край: 28.02.2031 Възраст: до 10 г. Лечение

Australia, Poland, United Kingdom +1 PTC Therapeutics NCT06302348

Набира участници Фаза 1/2

Study of ARO-DM1 in Subjects With Type 1 Myotonic Dystrophy

Myotonic Dystrophy 1

This is a phase 1/2a double-blinded, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of ARO-DM1 compared to placebo in male and female subjects with type 1 myotonic dystrophy (DM1). Participants who have provided written informed consent and met all protocol eligibility requirements will be randomized to receive single (Part 1) or multiple (Part 2) doses of ARO-DM1 or placebo.

Начало: 04.03.2024 Край: 01.12.2026 Възраст: 18–65 г. Лечение

Australia, New Zealand, Taiwan +1 Arrowhead Pharmaceuticals NCT06138743

Набира участници

Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia

Critical Limb-Threatening Ischemia Critical Limb Ischemia Critical Lower Limb Ischemia

The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Up to 30 subjects will be enrolled at approximately 3 clinical sites in Australia.

Начало: 04.03.2024 Край: 31.12.2030 Възраст: от 18 г. Лечение

Australia R3 Vascular Inc. NCT06075940

Набира участници Фаза 2

A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD

Graft Versus Host Disease, Acute

This study is a prospective randomized placebo-controlled phase 2 study to compare CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and throughout the study using Mount Sinai Acute GvHD International Consortium (MAGIC) guidelines. Eligible subjects will be randomized to receive either CYP-001 IV infusion on Days 0 and 4 or placebo on the same days. All subjects will receive ongoing CS therapy as appropriate per institutional guidelines. Subjects will have study visits up to Day 100 during the Primary Evaluation Period. During the Follow-Up Period, subjects will have study visits up to 24 months.

Начало: 04.03.2024 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, France, Italy +4 Cynata Therapeutics Limited NCT05643638

Набира участници

Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Degenerative Disc Disease Spondylolisthesis

The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion. It is estimated that up to 30 participants will be enrolled in approximately 3 clinical sites. During baseline and follow-up assessments, patients will be asked to undergo x-rays and CT scans; adverse events and immunology will be collected, and; participants will be requested to complete participant questionnaires regarding quality of life, pain and function.

Начало: 01.03.2024 Край: 01.06.2026 Възраст: 17–70 г. Лечение

Australia Bone Biologics Corp NCT03810573

Набира участници Фаза 2

Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN

C3 Glomerulopathy Idiopathic Immune Complex-Mediated Glomerulonephritis

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OMS906 in patients with C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)

Начало: 01.03.2024 Край: 01.04.2026 Възраст: 18–99 г. Лечение

Lithuania, New Zealand, Poland +1 Omeros Corporation NCT06209736

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

Dermatitis Atopic

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).

Начало: 29.02.2024 Край: 14.09.2026 Възраст: от 12 г. Лечение

Argentina, Australia, Brazil +20 Sanofi NCT06241118

Набира участници Фаза 2/3

A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Solid Cancer

This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.

Начало: 27.02.2024 Край: 30.04.2030 Възраст: от 18 г. Лечение

Australia, Canada, China +11 Daiichi Sankyo NCT06161025

Набира участници Фаза 2

A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors

Advanced Solid Tumor Melanoma Head and Neck Cancer Gastric Cancer +10

This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \[cutaneous/acral\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.

Начало: 26.02.2024 Край: 10.10.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +13 Daiichi Sankyo NCT06172478

Набира участници Фаза 1

SNV1521 in Participants With Advanced Solid Tumors

Advanced Solid Tumor

This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.

Начало: 23.02.2024 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, Canada, France +3 Synnovation Therapeutics, Inc. NCT06220864

Набира участници

New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.

Hearing Loss

The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Master Umbrella Clinical Investigation will be comprised of several sub-investigations, which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.

Начало: 22.02.2024 Край: 31.10.2026 Възраст: от 18 г. Фундаментална наука

Australia Cochlear NCT06100393

Набира участници

An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema

Emphysema, Pulmonary Emphysema or COPD

This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.

Начало: 22.02.2024 Край: 31.03.2028 Възраст: 40–80 г. Лечение

Australia, Denmark, France +5 Pulmonx Corporation NCT06035120

Набира участници Фаза 1/2

Study of ARO-DUX4 in Adult and Adolescent Patients With Facioscapulohumeral Muscular Dystrophy Type 1

Facio-Scapulo-Humeral Dystrophy

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ARO-DUX4 in participants with facioscapulohumeral muscular dystrophy Type 1 (FSHD1). In Part 1 of the study, participants will receive one dose of ARO-DUX4 or placebo. In Part 2 of the study, participants will receive 4 doses of ARO-DUX4 or placebo. Participants who complete Part 1 will have the option to re-screen and re-randomize into Part 2. All participants will undergo pre- and post-dose MRI-guided muscle biopsies (a total of 2 biopsies). Participants who complete Part 1 and enroll in Part 2 will be required to undergo an additional screening biopsy. Participants completing Part 1 or Part 2 may have the option to continue to receive drug in an open-label extension study or may be eligible to participate in later-stage clinical studies.

Начало: 22.02.2024 Край: 01.12.2026 Възраст: 16–70 г. Лечение

Australia, Canada, Germany +5 Arrowhead Pharmaceuticals NCT06131983

Набира участници

A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.

Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))

The purpose of this study is to evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total hip replacement surgery compared to currently available stems used for the same type of surgery. It is hypothesised the 2-year survivorship of the Insignia stem is noninferior to the benchmark survivorship of similar stems used in the same type of surgery.

Начало: 22.02.2024 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia Stryker Australia Pty Ltd. NCT06108934

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