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NCT00040027 · ClinicalTrials.gov registry record · Phase 3
Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients 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
NCT00040027 is a Phase 3 study that has completed, run by SciClone Pharmaceuticals. The registered enrollment target is 500 participants.
The verdict
NCT00040027, 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 without 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) + PEGinterferon alfa-2a
- DRUG placebo + PEGinterferon alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2002-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00040027
The ClinicalTrials.gov registry entry for NCT00040027 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SciClone Pharmaceuticals, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a is the first listed.
NCT00040027 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00040027 about?
NCT00040027 is a clinical study titled "Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients 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 NCT00040027?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2002-04.
What interventions are being tested in trial NCT00040027?
The interventions under investigation include: thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a (DRUG), placebo + PEGinterferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT00040027?
This trial is sponsored by SciClone Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
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