IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
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
This study has been completed.
Sponsor:
SciClone Pharmaceuticals
Information provided by (Responsible Party):
SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00968357
First received: August 27, 2009
Last updated: June 6, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Chronic Hepatitis C | Drug: SCV-07 | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| 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 |
Resource links provided by NLM:
Further study details as provided by SciClone Pharmaceuticals:
Primary Outcome Measures:
- To assess the safety of SCV-07 at 2 dose levels given as a monotherapy and to assess the immunomodulatory effects of SCV-07 given at 2 dose levels for 4 weeks and in combination with ribavirin for 4 weeks after monotherapy, respectively. [ Time Frame: 8 weeks ]
Secondary Outcome Measures:
- To assess the pharmacodynamic effects of SCV 07 and the pharmacokinetics as a monotherapy and in combination with ribavirin [ Time Frame: 8 weeks ]
| Enrollment: | 40 |
| Study Start Date: | September 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SCV-07
Cohort 1: SCV-07 0.1 mg/kg. Cohort 2: 1.0 mg/kg per day administered SC
|
Drug: SCV-07
SCV-07 dosage will remain the same throughout the study for each cohort. Monotherapy Lead-in Phase Treatment (SCV-07) for 4 weeks. Combination Treatment (SCV-07 and ribavirin) for 4 weeks, following "Lead-in Phase". Re-treatment with peg INF and RBV will be offered in the "Follow-up" to patients who in the opinion of the investigator may benefit from treatment. All patients will have a total of 3 follow-up visits for safety assessments. Women of childbearing potential will be followed up monthly for approximately up to 6 months after the "end of treatment" visit. If pregnancy occurs within the follow-up period, it needs to be followed through 8 weeks after the end of pregnancy.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult subjects must have compensated liver disease
- Subjects must have a history of chronic hepatitis C (genotype 1), and must be relapsers
- Subject's HCV RNA viral load must be > or = 300,000 IU/mL
- Subjects must have documentation of a liver biopsy within the last 2 years
Exclusion Criteria:
- Human immunodeficiency virus (HIV) infection or hepatitis B surface antigen (HBsAg)-positive
- Clinical evidence of cirrhosis
- Autoimmune hepatitis or other autoimmune/immune-active diseases
- Insulin-dependent diabetes
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968357
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968357
Locations
| United States, California | |
| AGMG Clinical Research | |
| Anaheim, California, United States, 92803 | |
| Impact Clinical Trials | |
| Los Angeles, California, United States, 90036 | |
| A Professional Corporation | |
| Palm Springs, California, United States, 92262 | |
| United States, Colorado | |
| Arapahoe Gastroenterology | |
| Littleton, Colorado, United States, 80120 | |
| United States, District of Columbia | |
| Washington Hospital Center-MedStar Research Institute | |
| Washington, District of Columbia, United States, 20010 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307 | |
| United States, Florida | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Atlanta Gastroenterology Associates | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| Commonwealth Biomedical Research, LLC | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Maryland | |
| Paul Thuluvath | |
| Baltimore, Maryland, United States, 21202 | |
| United States, North Carolina | |
| Duke University Department of Medicine | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Tennessee | |
| Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Baylor College of Medicine (VAMC 15) | |
| Houston, Texas, United States | |
| United States, Virginia | |
| Kaiser Permanente | |
| Falls Church, Virginia, United States | |
Sponsors and Collaborators
SciClone Pharmaceuticals
More Information
Additional Information:
| Responsible Party: | SciClone Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00968357 History of Changes |
| Obsolete Identifiers: | NCT00514631 |
| Other Study ID Numbers: |
SCI-SCV-HCV-P2-001 |
| Study First Received: | August 27, 2009 |
| Last Updated: | June 6, 2012 |
Keywords provided by SciClone Pharmaceuticals:
|
SCV-07 relapsers Hepatitis C |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Ribavirin Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on July 24, 2017