Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1)

Phase 3

Completed

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

• Registration Number: NCT01343888
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Disposition First Submitted: 2014-03-27
• Disposition First Submitted QC: 2014-03-27
• Disposition First Posted: 2014-04-24
• Results First Submitted: 2015-07-03
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-18
• Last Update Submitted: 2015-08-18
• Results First Posted: 2015-09-18
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 656

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PegIFN/RBV	PegIFN/RBV	PegIFN/RBV for 48 weeks
BI 201335 for 12 or 24 weeks	PegIFN/RBV	BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
BI 201335 for 12 or 24 weeks	BI 201335	BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
Placebo and PegIFN/RBV	PegIFN/RBV	Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Placebo and PegIFN/RBV	Placebo	Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.

Primary Outcome Measures

Name	Time	Method
Sustained Virological Response 12 Weeks Post-treatment (SVR12)	12 weeks post treatment, up to 60 weeks	Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level \< 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

Secondary Outcome Measures

Name	Time	Method
Early Treatment Success (ETS)	week 4 and week 8	Early treatment success (ETS), defined as a plasma HCV RNA level \<25 IU/mL (detected or undetected) at week 4 and HCV RNA \<25 IU/mL (undetected) at week 8.
Sustained Virological Response 24 Weeks Post-treatment (SVR24)	24 weeks post treatment, up to 72 weeks	Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level \< 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES	12 weeks post treatment, up to 60 weeks	This will be presented as the number of patients. BL = Baseline
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO	12 weeks post treatment, up to 60 weeks	This will be presented as the number of patients. BL = Baseline
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES	12 weeks post treatment, up to 60 weeks	This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO	12 weeks post treatment, up to 60 weeks	This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES	12 weeks post treatment, up to 60 weeks	This will be presented as the number of patients. BL = Baseline
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO	12 weeks post treatment, up to 60 weeks	This will be presented as the number of patients. BL = Baseline
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES	12 weeks post treatment, up to 60 weeks	This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO	12 weeks post treatment, up to 60 weeks	This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Trial Locations

Locations (98)

1220.30.4303 Boehringer Ingelheim Investigational Site; 🇦🇹 Linz, Austria

1220.30.4301 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1220.30.4302 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1220.30.4304 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1220.30.3201 Boehringer Ingelheim Investigational Site; 🇧🇪 Bruxelles, Belgium

1220.30.3207 Boehringer Ingelheim Investigational Site; 🇧🇪 Bruxelles, Belgium

1220.30.3204 Boehringer Ingelheim Investigational Site; 🇧🇪 Edegem, Belgium

1220.30.3205 Boehringer Ingelheim Investigational Site; 🇧🇪 Gent, Belgium

1220.30.3202 Boehringer Ingelheim Investigational Site; 🇧🇪 Leuven, Belgium

1220.30.3203 Boehringer Ingelheim Investigational Site; 🇧🇪 Liège, Belgium

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