IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

Phase 3

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: BI 201335 (Faldaprevir); Drug: Ribavirin (RBV); Drug: BI 207127; Drug: Faldaprevir (BI 201335)

• Registration Number: NCT01732796
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-26
• Study Start: 2012-12
• Disposition First Submitted: 2014-06-25
• Disposition First Submitted QC: 2014-06-25
• Disposition First Posted: 2014-06-27
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2016-01-21
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-17
• Last Update Submitted: 2016-03-17
• Results First Posted: 2016-04-18
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allocated 24 weeks BI 207127 + BI 201335	BI 201335 (Faldaprevir)	24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
Allocated 24 weeks BI 207127 + BI 201335	BI 207127	24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
Randomized 16 weeks BI 7127+BI1335 + RBV	BI 201335 (Faldaprevir)	16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
Randomized 16 weeks BI 7127+BI1335 + RBV	Ribavirin (RBV)	16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
Randomized 16 weeks BI 7127+BI1335 + RBV	BI 207127	16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
Allocated 24 weeks BI 207127 + BI 201335	Ribavirin (RBV)	24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
Randomized 24weeks BI 7127+ BI1335 + RBV	BI 207127	24 weeks of BI 207127and BI 201335 in combination with RBV
Randomized 24weeks BI 7127+ BI1335 + RBV	Faldaprevir (BI 201335)	24 weeks of BI 207127and BI 201335 in combination with RBV
Randomized 24weeks BI 7127+ BI1335 + RBV	Ribavirin (RBV)	24 weeks of BI 207127and BI 201335 in combination with RBV

Primary Outcome Measures

Name	Time	Method
SVR12 Rates With Historical Control	12 Week (post-treatment)	Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level \<25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint
Comparisons of SVR12 Rates Across Treatment Arms	12 Week (post-treatment)	Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.

Secondary Outcome Measures

Name	Time	Method
SVR4	4 Week (post-treatment)	Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).
SVR24	24 Week (post-treatment)	Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).

Trial Locations

Locations (101)

1241.20.00026 Boehringer Ingelheim Investigational Site; 🇺🇸 Dothan, Alabama, United States

1241.20.00033 Boehringer Ingelheim Investigational Site; 🇺🇸 Chula Vista, California, United States

1241.20.00006 Boehringer Ingelheim Investigational Site; 🇺🇸 La Mesa, California, United States

1241.20.00003 Boehringer Ingelheim Investigational Site; 🇺🇸 Oceanside, California, United States

1241.20.00008 Boehringer Ingelheim Investigational Site; 🇺🇸 Poway, California, United States

1241.20.00015 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Lauderdale, Florida, United States

1241.20.00014 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Pierce, Florida, United States

1241.20.00004 Boehringer Ingelheim Investigational Site; 🇺🇸 Maitland, Florida, United States

1241.20.00010 Boehringer Ingelheim Investigational Site; 🇺🇸 Decatur, Georgia, United States

1241.20.00001 Boehringer Ingelheim Investigational Site; 🇺🇸 New Orleans, Louisiana, United States

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