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NCT00039962 · ClinicalTrials.gov registry record · Phase 3
Thymosin Plus PEG-Interferon in Hepatitis C Patients With Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
A Phase 3 study, sponsored by SciClone Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
NCT00039962: Completed Phase 3 study, sponsored by SciClone Pharmaceuticals.
NCT00039962 is a Phase 3 study that has completed, run by SciClone Pharmaceuticals. The registered enrollment target is 500 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00039962, a Phase 3 study, has completed, sponsored by SciClone Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
Study Summary
Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the United States. Approximately one-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or liver cancer. The current treatment for hepatitis C infection in previously untreated patients is successful in only about half of patients. There is no established therapy for non-responders. This is a randomized, double-blinded, multicenter trial to determine the effectiveness of thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C with early cirrhosis or progression to cirrhosis who are non-responders to previous treatment with interferon or interferon plus ribavirin. The definition of non-response requires a positive HCV RNA test at the end of a course of at least 12 weeks of therapy. Patients will receive treatment for 12 months, and will be followed-up for a further 6 months after the end of therapy
Interventions
- DRUG thymalfasin (thymosin alpha 1)
- DRUG PEGinterferon alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2002-05 |
| Phase | Phase 3 |
What the finished NCT00039962 record still lists
NCT00039962 is an interventional study that assigns participants to a tested intervention. The registered 500 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 (35% lower).
The record links to 0 conditions, and to 2 interventions - of which thymalfasin (thymosin alpha 1) is the first listed.
NCT00039962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00039962 about?
NCT00039962 is a clinical study titled "Thymosin Plus PEG-Interferon in Hepatitis C Patients With Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin". Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the United States. Approximately one-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or liver cancer. The current treatment for hepatitis C infection in...
What is the current status of trial NCT00039962?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2002-05.
What interventions are being tested in trial NCT00039962?
The interventions under investigation include: thymalfasin (thymosin alpha 1) (DRUG), PEGinterferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT00039962?
This trial is sponsored by SciClone Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00039962's enrollment target sits among peer trials
500 744th of 2000 higher than 1,226 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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