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NCT00516321 · ClinicalTrials.gov registry record · Phase 3
Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 687
- Enrollment target
NCT00516321: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00516321 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 687 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00516321, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 687 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).
Primary Outcome
Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase.
Interventions
- DRUG placebo
- DRUG eltrombopag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 687 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
What the finished NCT00516321 record still lists
NCT00516321 is an interventional study that assigns participants to a tested intervention. The registered 687 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00516321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00516321 about?
NCT00516321 is a clinical study titled "Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease". The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will...
What is the current status of trial NCT00516321?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 687 participants. The study started on 2007-10. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00516321?
The interventions under investigation include: placebo (DRUG), eltrombopag (DRUG).
Who is sponsoring clinical trial NCT00516321?
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 NCT00516321's enrollment target sits among peer trials
687 525th of 2000 higher than 1,476 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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