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NCT00244751 · ClinicalTrials.gov registry record · Phase 2
Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 265
- Enrollment target
NCT00244751: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00244751 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 265 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00244751, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 265 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the safety and effectiveness of GI262570 compared to placebo (a pill that looks exactly like GI262570 but contains no active medicine) in improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who are enrolled in the study must have had prior treatment with interferon (either pegylated or standard interferon) plus ribavirin for at least 12 weeks to treat their hepatitis C, but either failed to clear the virus or didn't tolerate the treatment.
Primary Outcome
A percutaneous liver biopsy was obtained at the screening visit and at Week 52. A new liver biopsy at the screening visit was not taken in the event that a previous liver biopsy taken within 120 days of the Baseline /Day 1 visit (day of first dose), and the tissue block was available. The immunohistochemical marker assessed was smooth muscle alpha-actin (aSMA). Sections of the liver biopsies were stained by standard immunocytochemical techniques using a monoclonal antibody to smooth muscle actin
Interventions
- DRUG Placebo
- DRUG GI262570 0.5 mg
- DRUG GI262570 1.0 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2005-11-02 |
| Est. Completion | 2008-03-13 |
| Phase | Phase 2 |
What the finished NCT00244751 record still lists
NCT00244751 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00244751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00244751 about?
NCT00244751 is a clinical study titled "Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects". The purpose of this study is to examine the safety and effectiveness of GI262570 compared to placebo (a pill that looks exactly like GI262570 but contains no active medicine) in improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who are enrolled in the study mus...
What is the current status of trial NCT00244751?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 265 participants. The study started on 2005-11-02. Estimated completion is 2008-03-13.
What interventions are being tested in trial NCT00244751?
The interventions under investigation include: Placebo (DRUG), GI262570 0.5 mg (DRUG), GI262570 1.0 mg (DRUG).
Who is sponsoring clinical trial NCT00244751?
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 NCT00244751's enrollment target sits among peer trials
265 210th of 2000 higher than 1,791 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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