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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00968357
Other study ID # SCI-SCV-HCV-P2-001
Secondary ID
Status Completed
Phase Phase 2
First received August 27, 2009
Last updated June 6, 2012
Start date September 2009
Est. completion date January 2011

Study information

Verified date June 2012
Source SciClone Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Other known NCT identifiers
  • NCT00514631

Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

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.

Locations

Country Name City State
United States AGMG Clinical Research Anaheim California
United States Atlanta Gastroenterology Associates Atlanta Georgia
United States Paul Thuluvath Baltimore Maryland
United States University of Cincinnati Medical Center Cincinnati Ohio
United States Duke University Department of Medicine Durham North Carolina
United States Kaiser Permanente Falls Church Virginia
United States Baylor College of Medicine (VAMC 15) Houston Texas
United States Arapahoe Gastroenterology Littleton Colorado
United States Impact Clinical Trials Los Angeles California
United States University of Louisville Louisville Kentucky
United States Commonwealth Biomedical Research, LLC Madisonville Kentucky
United States University of Miami School of Medicine Miami Florida
United States Vanderbilt Medical Center Nashville Tennessee
United States A Professional Corporation Palm Springs California
United States Walter Reed Army Medical Center Washington District of Columbia
United States Washington Hospital Center-MedStar Research Institute Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
SciClone Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary To assess the pharmacodynamic effects of SCV 07 and the pharmacokinetics as a monotherapy and in combination with ribavirin 8 weeks No
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Recruiting NCT01178749 - Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments N/A
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Completed NCT00537407 - A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment Phase 2
Recruiting NCT00370617 - Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance Phase 4
Completed NCT01684787 - Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients Phase 4
Active, not recruiting NCT00225537 - 4-Methylumbelliferone as a Treatment for Chronic HBV/HCV Phase 2

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