Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects: Part A: Safety and Efficacy of INX-08189 With Peg IFN Alfa-2a and Ribavirin. Part B: INX-08189 in Interferon Free Treatment With Daclatasvir and/or Ribavirin

PHASE2TerminatedINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
Hepatitis C
Interventions
DRUG

INX-08189

Tablet, Oral, 25 mg, Once daily (QD), 12 weeks

DRUG

INX-08189

Tablet, Oral, 50 mg, Once daily (QD), 12 weeks

DRUG

INX-08189

Tablet, Oral, 100 mg, Once daily (QD), 12 weeks

DRUG

Placebo matching with INX-08189

Tablet, Oral, 0 mg, Once daily (QD), 12 weeks

BIOLOGICAL

Pegylated interferon alfa-2a

Syringe, Subcutaneous injection, 180 μg, Once per week, 12 weeks

DRUG

Ribavirin

Tablet, Oral, 500 or 600 mg weight dependent, Twice daily (BID), 12 weeks

DRUG

INX-08189

Tablet, Oral, 200 mg, QD, 12 weeks

DRUG

Daclatasvir

Tablet, Oral, 60 mg, QD, 12 weeks

Trial Locations (6)

64111

Kansas City Cancer Centers, Llc., Kansas City

74104

Options Health Research, Llc, Tulsa

78215

Alamo Medical Research, San Antonio

92037

Scripps Health Dba Scripps Clinical Research Services, La Jolla

92801

Acri Phase One, Anaheim

94115

Quest Clinical Research, San Francisco

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT01425970 - Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects: Part A: Safety and Efficacy of INX-08189 With Peg IFN Alfa-2a and Ribavirin. Part B: INX-08189 in Interferon Free Treatment With Daclatasvir and/or Ribavirin | Biotech Hunter | Biotech Hunter