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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan (R-DXd) in people with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. This study includes two parts: Phase 2 to find the best dose based on safety and response, and Phase 3 to compare R-DXd with the investigator's choice of chemotherapy. R-DXd is an antibody-drug conjugate that targets CDH6, a protein overexpressed in tumor cells. Participants will receive R-DXd through intravenous infusions. In Phase 2 (Part A), the dose will be optimized, and biopsies will be collected before and during treatment if possible. In Phase 3 (Part B), participants will be randomly assigned to receive either R-DXd or chemotherapy chosen by their doctor, which may include paclitaxel, topotecan, or PLD, all given by IV infusion. The study monitors treatment effects up to 18 months in Phase 2 and up to 26 months in Phase 3. During the study, participants will have regular scans and assessments to measure tumor response and progression-free survival. Researchers will monitor safety and organ function through lab tests and performance status evaluations. Participants must be willing to follow the study visits and procedures, which include biopsy samples in Phase 2 and imaging assessments to evaluate treatment response. The study aims to provide detailed information about how well R-DXd works and its safety in this patient group.

Age: 18Years +All GendersPhase 2Phase 3
129 locations
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Actively Recruiting

Researchers are evaluating how well teduglutide works over 24 weeks in Chinese adults with short bowel syndrome (SBS) who rely on parenteral support. The study aims to measure how much teduglutide can reduce the amount of parenteral support needed and to understand how the body absorbs, processes, and eliminates the drug. This is a Phase 3 open-label study focused on assessing efficacy, safety, and pharmacokinetics in this population. Participants will receive a daily subcutaneous injection of teduglutide at a dose of 0.05 mg/kg for 24 weeks. After the treatment period, safety monitoring will continue for an additional 24 weeks. The study includes a total participation time of about 65 weeks, covering treatment and follow-up phases. During the study, participants' parenteral support volume will be closely monitored to assess reductions from baseline through week 24. Researchers will also evaluate safety and how the body handles the drug. Various assessments, including clinical evaluations, laboratory tests, and monitoring of parenteral support use, will be conducted throughout the study and follow-up periods to track treatment effects and participant health.

Age: 18Years +All GendersPhase 3
4 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of low-dose tenecteplase in elderly patients who have experienced an acute ischemic stroke. This prospective, multicenter, randomized controlled Phase 4 trial focuses on patients aged 70 years and older who receive treatment within 4.5 hours of stroke onset. The study aims to compare low-dose tenecteplase with the standard dose to understand its impact on stroke recovery in aging patients. Participants are randomly assigned to one of two groups: a low-dose group receiving tenecteplase at 0.175 mg/kg (up to 17.5 mg per patient) or a standard-dose group receiving tenecteplase at 0.25 mg/kg (up to 25 mg per patient). Treatment is administered intravenously as thrombolysis. The trial monitors patients closely to assess how these dosing strategies affect recovery and safety. During the study, researchers will evaluate neurological function using the Modified Rankin Scale 90 days after treatment, measuring the percentage of participants who achieve a score of 0 or 1, indicating no symptoms or no significant disability. Patients will undergo neurological assessments and safety monitoring throughout the trial. The study ensures informed consent and collects relevant clinical data to support its findings on tenecteplase use in elderly stroke patients.

Age: 70Years +All GendersPhase 4
49 locations
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