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NCT00621894 · ClinicalTrials.gov registry record · Phase 2
Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment Continuation
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT00621894: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00621894 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00621894, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the ability of LGD-4665 given daily by mouth to increase platelet counts in the treatment of patients with ITP (immune thrombocytopenic purpura). LGD-4665 increased platelet counts safely and tolerably compared to placebo in healthy volunteers. This study will examine the safety, tolerability and efficacy of 7.5 mg capsules of LGD-4665 to increase platelets compared to placebo, randomized 2:1, during blinded treatment for 6 weeks. Evaluation of platelet counts, bleeding scores and safety parameters will be done weekly. All patients are eligible to continue on active, open LGD-4665 treatment for an additional 12 weeks with optimal adjustment of dose for each patient.
Primary Outcome
Response was defined as platelet count \>= 50 x1000/uL for participants without Baseline steroid uses; or platelet counts \>= 50 x1000/uL and doubling the Baseline platelet counts for participants with baseline steroid uses. Confidence interval of response rate was computed using exact method of binomial proportion.
Interventions
- DRUG Placebo
- DRUG LGD-4665
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2008-03-15 |
| Est. Completion | 2009-05-15 |
| Phase | Phase 2 |
What the finished NCT00621894 record still lists
NCT00621894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00621894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00621894 about?
NCT00621894 is a clinical study titled "Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment Continuation". The purpose of this study is to assess the ability of LGD-4665 given daily by mouth to increase platelet counts in the treatment of patients with ITP (immune thrombocytopenic purpura). LGD-4665 increased platelet counts safely and tolerably compared to placebo in healthy volunteers. This study will ...
What is the current status of trial NCT00621894?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2008-03-15. Estimated completion is 2009-05-15.
What interventions are being tested in trial NCT00621894?
The interventions under investigation include: Placebo (DRUG), LGD-4665 (DRUG).
Who is sponsoring clinical trial NCT00621894?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00621894's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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