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

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Chronic Hepatitis C
Interventions
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."

Trial Locations (16)

20010

Washington Hospital Center-MedStar Research Institute, Washington D.C.

20307

Walter Reed Army Medical Center, Washington D.C.

21202

Paul Thuluvath, Baltimore

27710

Duke University Department of Medicine, Durham

30308

Atlanta Gastroenterology Associates, Atlanta

33136

University of Miami School of Medicine, Miami

37212

Vanderbilt Medical Center, Nashville

40202

University of Louisville, Louisville

42431

Commonwealth Biomedical Research, LLC, Madisonville

45267

University of Cincinnati Medical Center, Cincinnati

80120

Arapahoe Gastroenterology, Littleton

90036

Impact Clinical Trials, Los Angeles

92262

A Professional Corporation, Palm Springs

92803

AGMG Clinical Research, Anaheim

Unknown

Baylor College of Medicine (VAMC 15), Houston

Kaiser Permanente, Falls Church

Sponsors
All Listed Sponsors
lead

SciClone Pharmaceuticals

INDUSTRY