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
Public ClinicalTrials.gov record NCT00968357. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multicenter, Multidose, Open-Label Study to Evaluate the Safety and Immunomodulatory Effects of SCV-07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Genotype 1 Chronic Hepatitis C Who Have Relapsed After a Response to a Course of at Least 44 Weeks Treatment With Pegylated Interferon and Ribavirin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00968357
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2009
- Primary completion
- Dec 31, 2010
- Completion
- Dec 31, 2010
- Last update posted
- Jun 7, 2012
2009 – 2011
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AGMG Clinical Research | Anaheim | California | 92803 | — |
| Impact Clinical Trials | Los Angeles | California | 90036 | — |
| A Professional Corporation | Palm Springs | California | 92262 | — |
| Arapahoe Gastroenterology | Littleton | Colorado | 80120 | — |
| Washington Hospital Center-MedStar Research Institute | Washington D.C. | District of Columbia | 20010 | — |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | — |
| University of Miami School of Medicine | Miami | Florida | 33136 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30308 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | — |
| Paul Thuluvath | Baltimore | Maryland | 21202 | — |
| Duke University Department of Medicine | Durham | North Carolina | 27710 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | — |
| Vanderbilt Medical Center | Nashville | Tennessee | 37212 | — |
| Baylor College of Medicine (VAMC 15) | Houston | Texas | — | — |
| Kaiser Permanente | Falls Church | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00968357, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 7, 2012 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00968357 live on ClinicalTrials.gov.