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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

NCT01425970 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2015-11-04

No results posted yet for this study

Summary

Part A: The purpose of this study is to evaluate the safety and tolerability of INX-08189 and placebo with Peginterferon alfa-2a and Ribavirin during 12 weeks of treatment

Part B: The purpose of this study is to evaluate the safety and tolerability of INX-08189 with Ribavirin or INX-08189 with Daclatasvir or INX-08189 with Daclatasvir and Ribavirin

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01425970 on ClinicalTrials.gov