A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

Phase 3

Completed

• Conditions: Chronic Hepatitis C Infection
• Interventions: Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin; Drug: Placebo for ABT-450/r/ABT-267; Drug: Placebo for ABT-333; Drug: Placebo for ribavirin

• Registration Number: NCT01715415
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-29
• Study Start: 2012-11
• Primary Completion: 2013-11
• Study Completion: 2014-10
• Results First Submitted: 2014-12-23
• Results First Submitted QC: 2014-12-23
• Results First Posted: 2015-01-06
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

Inclusion Criteria

• Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.
• Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL at screening.
• Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).
• No evidence of liver cirrhosis.

Exclusion Criteria

• Positive screen for drugs or alcohol.
• Significant sensitivity to any drug.
• Use of contraindicated medications within 2 weeks of dosing.
• Certain predefined abnormal laboratory tests.
• Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-450/r/ABT-267 and ABT-333, plus RBV	ABT-450/r/ABT-267, ABT-333	Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV	Placebo for ABT-450/r/ABT-267	Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV	Placebo for ABT-333	Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV	ABT-450/r/ABT-267, ABT-333	Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV	Placebo for ribavirin	Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
ABT-450/r/ABT-267 and ABT-333, plus RBV	Ribavirin	Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV	Ribavirin	Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment	12 weeks after the last actual dose of active study drug	The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment	12 weeks after the last actual dose of active study drug	The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.
Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm	12 weeks after the last actual dose of active study drug	Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid \[HCV RNA\] ≥ lower limit of quantification \[LLOQ\] after HCV RNA \< LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.
Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period	At 12 weeks	Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.
Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment	12 weeks after the last actual dose of active study drug	The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.
Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm	Within 12 weeks post-treatment	Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA \< LLOQ at the end of treatment.