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NCT02700529 · ClinicalTrials.gov registry record · Phase 2
Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA)
A Phase 2 study of Lymphedema, sponsored by Eiger BioPharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 4
- Study locations
NCT02700529: Completed Phase 2 study of Lymphedema, sponsored by Eiger BioPharmaceuticals.
NCT02700529 is a Phase 2 study of Lymphedema that has completed, run by Eiger BioPharmaceuticals. The registered enrollment target is 54 participants, below the 9,298-participant average among 34 other Lymphedema trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02700529, a Phase 2 study of Lymphedema, has completed, sponsored by Eiger BioPharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 4
- Study locations
Study Summary
This proof-of-concept study is designed as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150 mg, 3 times daily (total daily dose of 450 mg) with placebo for 6 months treatment period in patients with leg lymphedema.
Primary Outcome
Change from baseline to Week 24 in skin thickness of the calf of the most affected leg, measured by skinfold calipers in the Skin-Thickness Intent-to-Treat (ST-ITT) population (patients with skin thickness \>/= 10 mm at baseline) which comprised of 36 patients (16 ubenimex, 20 placebo).
Conditions Studied
Interventions
- OTHER placebo
- DRUG ubenimex
Study Locations (4)
California
- Stanford University - Stanford
Florida
- Orlando Health, Inc. - Orlando
Ohio
- The Ohio State University Wexner Medical Center James Cancer Hospital - Columbus
New South Wales
- Macquarie University Hospital (MUH) - Sydney
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2016-06 |
| Est. Completion | 2019-02 |
| Phase | Phase 2 |
What the finished NCT02700529 record still lists
NCT02700529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 9,298-participant average among 34 other Lymphedema trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Lymphedema appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT02700529 reports a single indexed study location in California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT02700529 about?
NCT02700529 is a clinical study titled "Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA)". This proof-of-concept study is designed as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150 mg, 3 times daily (total daily dose of 450 mg) with placebo for 6 months treatment period in patients with leg lymphedema.
What is the current status of trial NCT02700529?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2016-06. Estimated completion is 2019-02.
What conditions does trial NCT02700529 study?
This clinical trial studies the following conditions: Lymphedema.
What interventions are being tested in trial NCT02700529?
The interventions under investigation include: placebo (OTHER), ubenimex (DRUG).
Who is sponsoring clinical trial NCT02700529?
This trial is sponsored by Eiger BioPharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02700529 being conducted?
This trial has 4 study locations across California, Florida, Ohio, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02700529's enrollment target sits among peer trials
54 28th of 34 higher than 7 of 34 other Lymphedema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphedema 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.
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