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NCT04120883 · ClinicalTrials.gov registry record · Phase 1
Oral Hydroxychloroquine (HCQ) for Retinitis Pigmentosa Caused by P23H- Rhodopsin (RHO)
A Phase 1 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04120883 is a Phase 1 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 8 participants.
The verdict
NCT04120883, a Phase 1 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This research study is being done to learn what effect 12 months of treatment with oral hydroxychloroquine (HCQ) will have on the retina in people with retinitis pigmentosa (RP). The hypothesis is that treatment with HCQ is safe and tolerable in patients with autosomal dominant retinitis pigmentosa (adRP) caused by P23H-RHO, and may arrest progression of retinal degeneration by altering the autophagy pathway in photoreceptors. Participants that meet eligibility and agree to the study will be asked to take the study medication (HCQ) for 12 months and have evaluations for up to approximately 18 months from the baseline visit. There will be a total of 6 visits (1 is a phone visit) and will include general examinations, blood work, electrocardiograms, along with special testing of the retina.
Interventions
- DRUG Hydroxychloroquine lower dose
- DRUG Hydroxychloroquine higher dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-02-25 |
| Est. Completion | 2024-08-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04120883
The ClinicalTrials.gov registry entry for NCT04120883 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hydroxychloroquine lower dose is the first listed.
NCT04120883 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04120883 about?
NCT04120883 is a clinical study titled "Oral Hydroxychloroquine (HCQ) for Retinitis Pigmentosa Caused by P23H- Rhodopsin (RHO)". This research study is being done to learn what effect 12 months of treatment with oral hydroxychloroquine (HCQ) will have on the retina in people with retinitis pigmentosa (RP). The hypothesis is that treatment with HCQ is safe and tolerable in patients with autosomal dominant retinitis pigmentosa ...
What is the current status of trial NCT04120883?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2020-02-25. Estimated completion is 2024-08-05.
What interventions are being tested in trial NCT04120883?
The interventions under investigation include: Hydroxychloroquine lower dose (DRUG), Hydroxychloroquine higher dose (DRUG).
Who is sponsoring clinical trial NCT04120883?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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