A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection

Phase 3

Withdrawn

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: BI 201335; Drug: PegIFN/RBV

• Registration Number: NCT01608737
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objectives of this study are:

1. 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.

2. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-31
• Study Start: 2012-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-23
• Last Update Posted: 2013-02-26
• Primary Completion: 2015-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2. BI 201335 for 24 weeks	BI 201335	BI 201335 once daily low dose for 24 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
3. BI 201335 for 12 weeks	BI 201335	BI 201335 once daily high dose for 12 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
1. PegIFN/RBV	PegIFN/RBV	PegIFN/RBV for 48 weeks in treatment-naive patients
4. PegIFN/RBV	PegIFN/RBV	PegIFN/RBV for 48 weeks in prior relapser patients
5. BI 201335 for 12 weeks	BI 201335	BI 201335 once daily high dose for 12 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in prior relapser patients

Primary Outcome Measures

Name	Time	Method
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.	60 weeks

Secondary Outcome Measures

Name	Time	Method
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