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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCV-07 | Experimental | Cohort 1: SCV-07 0.1 mg/kg. Cohort 2: 1.0 mg/kg per day administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCV-07 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacodynamic effects of SCV 07 and the pharmacokinetics as a monotherapy and in combination with ribavirin | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AGMG Clinical Research | Anaheim | California | 92803 | United States | ||
| Impact Clinical Trials |
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| Label | URL |
|---|---|
| Pharmaceutical Company | View source |
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|
| Los Angeles |
| California |
| 90036 |
| United States |
| A Professional Corporation | Palm Springs | California | 92262 | United States |
| Arapahoe Gastroenterology | Littleton | Colorado | 80120 | United States |
| Washington Hospital Center-MedStar Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States |
| University of Miami School of Medicine | Miami | Florida | 33136 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30308 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | United States |
| Paul Thuluvath | Baltimore | Maryland | 21202 | United States |
| Duke University Department of Medicine | Durham | North Carolina | 27710 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Vanderbilt Medical Center | Nashville | Tennessee | 37212 | United States |
| Baylor College of Medicine (VAMC 15) | Houston | Texas | United States |
| Kaiser Permanente | Falls Church | Virginia | United States |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C470075 | golotimod |
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