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
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| ClinicalTrials.gov Identifier: NCT00968357 |
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Recruitment Status
:
Completed
First Posted
: August 31, 2009
Last Update Posted
: June 8, 2012
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Sponsor:
SciClone Pharmaceuticals
Information provided by (Responsible Party):
SciClone Pharmaceuticals
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Hepatitis C | Drug: SCV-07 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | September 2009 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ribavirin
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Experimental: SCV-07
Cohort 1: SCV-07 0.1 mg/kg. Cohort 2: 1.0 mg/kg per day administered SC
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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.
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Primary Outcome Measures
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- 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 ]
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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 |
| First Posted: | August 31, 2009 Key Record Dates |
| Last Update Posted: | June 8, 2012 |
| Last Verified: | June 2012 |
Keywords provided by SciClone Pharmaceuticals:
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SCV-07 relapsers Hepatitis C |
Additional relevant MeSH terms:
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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 |