Clinical Trials/NCT01608737

NCT01608737

Withdrawn

Phase 3

A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 for 12 or 24 Weeks in Combination With Pegylated interferon-a and Ribavirin in Treatment-naive and Prior Relapser Patients With Genotype 1 Chronic Hepatitis C Infection

Boehringer Ingelheim0 sitesSeptember 2012

ConditionsHepatitis C, Chronic

InterventionsBI 201335 PegIFN/RBV

DrugsPegIFN/RBV BI 201335

Overview

Phase: Phase 3
Intervention: BI 201335
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Primary Endpoint: Sustained Virological Response 12 weeks post-treatment (SVR12): Plasma Hepatitis C Virus (HCV) Ribonucleic Acid ( RNA) <25 IU/mL undetected at 12 weeks after the originally planned treatment duration.
Status: Withdrawn
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objectives of this study are:

To evaluate the efficacy and safety of two different treatment regimens with BI 201335 (high dose given for 12 weeks or low dose given for 24 weeks both in combination with Pegylated interferon-a and Ribavirin (PegIFN/RBV) as compared to PegIFN/RBV alone in treatment-naïve (TN) chronic genotype 1 hepatitis C virus infected patients.
Evaluate the efficacy and the safety of BI 201335 high dose given for 12 weeks in combination with PegIFN/RBV given for 24 to 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected relapser patients who failed a prior PegIFN/RBV treatment.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

October 2015

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

2. BI 201335 for 24 weeks

BI 201335 once daily low dose for 24 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients

Intervention: BI 201335

3. BI 201335 for 12 weeks

BI 201335 once daily high dose for 12 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients

Intervention: BI 201335

1. PegIFN/RBV

PegIFN/RBV for 48 weeks in treatment-naive patients

Intervention: PegIFN/RBV

4. PegIFN/RBV

PegIFN/RBV for 48 weeks in prior relapser patients

Intervention: PegIFN/RBV

5. BI 201335 for 12 weeks

BI 201335 once daily high dose for 12 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in prior relapser patients

Intervention: BI 201335

Outcomes

Primary Outcomes

Sustained Virological Response 12 weeks post-treatment (SVR12): Plasma Hepatitis C Virus (HCV) Ribonucleic Acid ( RNA) <25 IU/mL undetected at 12 weeks after the originally planned treatment duration.

Time Frame: 60 weeks

Secondary Outcomes

Virological response after 24 weeks of treatment discontinuation (SVR24): Plasma HCV RNA level <25 IU/mL, undetected; 24 weeks after the originally planned treatment duration(72 weeks)
Early Treatment Success (ETS): Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL, undetected at Week 8(8 weeks)
Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) normalisation. ALT and AST normal at end of treatment and post treatment.(72 weeks)