Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)

PHASE2CompletedINTERVENTIONAL
Enrollment

278

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2009

Conditions
Chronic Hepatitis C
Interventions
DRUG

Taribavirin

Oral (200 mg) Tablet: 20mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.

DRUG

Taribavirin

Oral (200 mg) Tablet: 25mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.

DRUG

Taribavirin

Oral (200mg)Tablet: 30mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.

DRUG

Ribavirin

Oral (200mg)Tablet: 800 mg/day, 1000 mg/day, 1200 mg/day, or 1400 mg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.

Trial Locations (1)

90048

Cedars-Sinai Medical Center, 8635 W. 3rd Street, Suite 590W, Los Angeles

All Listed Sponsors
lead

Bausch Health Americas, Inc.

INDUSTRY

NCT00446134 - Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV) | Biotech Hunter | Biotech Hunter