Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)
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- STATUS
- Recruiting
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- End date
- Jun 30, 2023
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- participants needed
- 50
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- sponsor
- Shanghai Children's Hospital
Summary
This Phase 2 randomized controlled trial will study the safety, tolerability, and efficacy of Hydroxychloroquine in qualified patients with Alport syndrome. The trial will be open-label, randomized, controlled and will enroll up to 50 patients.
Description
This Phase 2 randomized controlled trial will study the safety, tolerability, and efficacy of Hydroxychloroquine in qualified patients with Alport syndrome. The trial will be open-label, randomized, controlled and will enroll up to 50 patients.
Patients in the Phase 2 cohort will be randomized 1:1 to either Hydroxychloroquine Cohort or Comparator Cohort.
All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 4, 12, and 24. Patients will not receive study drug during a 24-week withdrawal period between Weeks 25 and 48. Patients will also be scheduled to be assessed at an in person follow up visit at Week 36, and 48.
Details
| Condition | Alport's Syndrome |
|---|---|
| Treatment | Hydroxychloroquine Sulfate 100 milligram (mg) Tab, Benazepril hydrochloride 10 milligram (mg) Tab |
| Clinical Study Identifier | NCT04937907 |
| Sponsor | Shanghai Children's Hospital |
| Last Modified on | 24 September 2021 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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