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NCT01591902 · ClinicalTrials.gov registry record · Phase 4
Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®
A Phase 4 study, sponsored by Theratechnologies.
- Terminated
- Registry status
- Phase 4
- Development phase
- 129
- Enrollment target
NCT01591902: Clinical Trial Phase 4 study, sponsored by Theratechnologies.
NCT01591902 is a Phase 4 study that was terminated before completion, run by Theratechnologies. The registered enrollment target is 129 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01591902, a Phase 4 study, was terminated before completion, sponsored by Theratechnologies.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 129 participants
- Enrollment target
Study Summary
To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).
Primary Outcome
Subjects will undergo an opthamologic examination including fundus photographs at 3 month intervals for duration of 36 months
Interventions
- DRUG Tesamorelin
- DRUG Placebo-Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2012-06 |
| Est. Completion | 2018-08 |
| Phase | Phase 4 |
Why NCT01591902 stopped before completion
NCT01591902 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Tesamorelin is the first listed.
NCT01591902 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01591902 about?
NCT01591902 is a clinical study titled "Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®". To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).
What is the current status of trial NCT01591902?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 129 participants. The study started on 2012-06. Estimated completion is 2018-08.
What interventions are being tested in trial NCT01591902?
The interventions under investigation include: Tesamorelin (DRUG), Placebo-Control (DRUG).
Who is sponsoring clinical trial NCT01591902?
This trial is sponsored by Theratechnologies, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01591902's enrollment target sits among peer trials
129 631st of 2000 higher than 1,367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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