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NCT00968357 · ClinicalTrials.gov registry record · Phase 2
Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed
A Phase 2 study, sponsored by SciClone Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00968357 is a Phase 2 study that has completed, run by SciClone Pharmaceuticals. The registered enrollment target is 40 participants.
The verdict
NCT00968357, a Phase 2 study, has completed, sponsored by SciClone Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
SCV-07 (γ-D-glutamyl-L-tryptophan) is a new immunomodulatory compound that has been developed and patented both for composition and immunomodulatory use and is a synthetic dipeptide. The efficacy of SCV 07 in treating chronic hepatitis C virus (HCV) infection is expected to arise from the drug's ability to stimulate the T-helper 1 (Th1) type immune response and to block signal transducers and activator of transcription 3 (STAT3) mediated signaling. The purpose of this study is to determine if SCV-07 alone and/or SCV-07 in combination with ribavirin is safe and potentially effective for the treatment of genotype 1 compensated chronic hepatitis C in subjects who have relapsed after a response to a previous treatment course of at least 44 weeks with pegylated interferon and ribavirin. All subjects will receive 4 weeks of SCV-07 (Lead-in Phase), followed by 4 weeks of treatment with SCV-07 in combination with ribavirin (Combination Treatment).
Interventions
- DRUG SCV-07
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00968357
The ClinicalTrials.gov registry entry for NCT00968357 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 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 1 intervention - of which SCV-07 is the first listed.
NCT00968357 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00968357 about?
NCT00968357 is a clinical study titled "Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed". SCV-07 (γ-D-glutamyl-L-tryptophan) is a new immunomodulatory compound that has been developed and patented both for composition and immunomodulatory use and is a synthetic dipeptide. The efficacy of SCV 07 in treating chronic hepatitis C virus (HCV) infection is expected to arise from the drug's abi...
What is the current status of trial NCT00968357?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2009-09. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00968357?
The interventions under investigation include: SCV-07 (DRUG).
Who is sponsoring clinical trial NCT00968357?
This trial is sponsored by SciClone Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
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