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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: Clinical Trial Phase 1 study, sponsored by University of Michigan.
NCT04120883 is a Phase 1 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
These will be performed at: screening, baseline, 4 months, 12 months, and 18 months
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 |
Why NCT04120883 stopped before completion
NCT04120883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Hydroxychloroquine lower dose is the first listed.
NCT04120883 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04120883's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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