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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the safety and effectiveness of SPH5030 tablets in patients with Her2-positive or mutated biliary tract or colorectal cancer. This Phase II clinical trial focuses on people with metastatic or advanced forms of these cancers who meet specific health criteria and have not previously received certain targeted therapies. Participants will receive SPH5030 tablets orally once daily at a dose of 600 mg. The study is designed as a single-arm, open-label trial conducted at multiple centers. Treatment continues as per protocol, with patients monitored for response and safety throughout the study period. During the trial, participants will be regularly assessed for their response to treatment, including the objective response rate over approximately two years. Researchers will monitor safety, side effects, and overall health through clinical evaluations and laboratory tests. The study includes ongoing observation to evaluate the drug's impact and patient well-being during and after treatment.

Age: 18Years +All GendersPhase 2
30 locations
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Actively Recruiting

This research aims to evaluate the effectiveness and safety of early treatment with BXOS110 injection in patients who have experienced an acute ischaemic stroke within 3 hours of symptom onset. The trial is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to clarify how well BXOS110 reduces overall disability after stroke compared to placebo. Participants include adults diagnosed with acute ischaemic stroke meeting specific neurological criteria. Participants are randomly assigned in equal numbers to receive either an intravenous infusion of BXOS110 at a dose of 3.0 mg/kg (up to a maximum of 300 mg) or a placebo infusion of the same volume and dose. The study consists of a screening and baseline period where consent and eligibility are confirmed within 3 hours of stroke onset, followed by a treatment phase where the assigned infusion is administered. Afterwards, participants enter a follow-up period with evaluations at Day 2, Day 3, Day 10 or discharge (whichever comes first), Day 30, and Day 90 after treatment. Throughout the study, participants will undergo assessments to monitor efficacy and safety, including the primary outcome of the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at Day 90, indicating reduced disability. Neurological status, adverse events, and overall health will be evaluated during scheduled visits. The total duration of participation spans from initial screening through the 90-day follow-up, with close monitoring to understand the impact of BXOS110 on stroke recovery.

Age: 18Years - 85YearsAll GendersPhase 3
9 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of LT3001 in treating adults who have experienced an acute ischemic stroke. This phase II, multicenter, randomized, double-blind, placebo-controlled study aims to understand how LT3001 impacts neurological impairment caused by stroke. Participants are between 18 and 80 years old and have a specific range of stroke severity based on the NIH Stroke Scale. Participants will be randomly assigned to receive either a high dose or low dose of LT3001 or a placebo, all given through intravenous infusion. The treatment must start within 24 hours after stroke onset. The study compares these groups to assess how LT3001 might help in acute ischemic stroke management. During the study, participants will be monitored for about two years to track any adverse events and evaluate safety. Researchers will assess neurological symptoms and overall health status through clinical evaluations and safety monitoring. Participants must consent to the study and agree to contraception guidelines if applicable. The long-term follow-up ensures careful observation of treatment effects and participant well-being.

Age: 18Years - 80YearsAll GendersPhase 2
28 locations
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Actively Recruiting

Researchers are evaluating the effectiveness and safety of the KPCXM18 injection at different doses for treating acute ischemic stroke in this multicenter, randomized, double-blind, placebo-controlled phase 2 trial. The study aims to determine how well the injection works and to explore its safety profile, including population pharmacokinetic characteristics, to support future phase 3 studies. Participants will be randomly assigned to one of three groups: a low-dose KPCXM18 injection group receiving 60 mg intravenously twice daily, a high-dose group receiving 100 mg intravenously twice daily, or a placebo group receiving a matching intravenous infusion. Treatments will be given every 122 hours continuously for 122 days to assess dose-related effects. During the study, participants will undergo assessments including the Modified Rankin Scale at day 90 to measure recovery. Researchers will monitor safety and efficacy throughout the treatment and follow-up periods. The total number of participants is planned to be 300, with 100 in each group, all aged between 18 and 80 years old who have experienced acute ischemic stroke within 12 hours of symptom onset.

Age: 18Years - 80YearsAll GendersPhase 2
23 locations
Heng Shui Shi Clinical Trials | DecenTrialz