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NCT01007448 · ClinicalTrials.gov registry record · Phase 4
Study Evaluating Two Dose Levels of Targretin Capsules in Participants With Refractory Cutaneous T-Cell Lymphoma (CTCL)
A Phase 4 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 4
- Development phase
- 59
- Enrollment target
NCT01007448: Completed Phase 4 study, sponsored by Bausch Health Americas.
NCT01007448 is a Phase 4 study that has completed, run by Bausch Health Americas. The registered enrollment target is 59 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01007448, a Phase 4 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 59 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy, tolerability, and safety of 2 initial dose levels of bexarotene capsules in participants with refractory CTCL.
Primary Outcome
Index lesion symptoms/grade include: erythema=0 (no evidence)-8 (very severe); scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence of change)-8 (very severe change); area of involvement=0 (0 centimeters \[cm\]\^2)-18 (\>300 cm\^2). CA generated by sum of grades of signs/symptoms for each index lesion. Index lesion CA grade at baseline was divided into CA grade at each subsequent study visit to determin
Interventions
- DRUG Bexarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2010-01-06 |
| Est. Completion | 2014-02-20 |
| Phase | Phase 4 |
What the finished NCT01007448 record still lists
NCT01007448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Bexarotene is the first listed.
NCT01007448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01007448 about?
NCT01007448 is a clinical study titled "Study Evaluating Two Dose Levels of Targretin Capsules in Participants With Refractory Cutaneous T-Cell Lymphoma (CTCL)". This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy, tolerability, and safety of 2 initial dose levels of bexarotene capsules in participants with refractory CTCL.
What is the current status of trial NCT01007448?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 59 participants. The study started on 2010-01-06. Estimated completion is 2014-02-20.
What interventions are being tested in trial NCT01007448?
The interventions under investigation include: Bexarotene (DRUG).
Who is sponsoring clinical trial NCT01007448?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01007448's enrollment target sits among peer trials
59 1202nd of 2000 higher than 796 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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