A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection

April 30, 2018 updated by: AbbVie (prior sponsor, Abbott)

A Phase 2 Study to Evaluate the Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection

This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b) or genotype 2 (HCV GT2) infection who were previous treated with pegylated interferon/ribavirin (pegIFN/RBV).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This multicenter, randomized, open-label, parallel-arm, combination treatment study consisted of a Treatment and Post-treatment Phase, divided into 2 cohorts: 1) chronic HCV GT1b- infected, pegIFN/RBV treatment-exposed Japanese adults; and 2) HCV GT2-infected, pegIFN/RBV treatment-exposed Japanese adults. The Treatment Phase evaluated the antiviral activity, safety, and pharmacokinetics of a range of ABT-450/r and ABT-267 doses for 12 to 24 weeks. The Post-treatment Phase evaluated the evolution and persistence of viral resistance to ABT-267 and ABT-450.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
  • Chronic hepatitis C, genotype 1b (HCV-GT1b) or genotype 2 (HCV GT2) infection (HCV RNA level greater than 10,000 IU/mL at screening) previously treated with pegylated interferon/ribavirin (pegIFN/RBV).
  • Subject's hepatitis C virus genotype is subgenotype 1b and subject was a null responder or partial responder, OR
  • Subject's hepatitis C virus genotype is subgenotype 2 and subject was a null responder, partial responder, or relapser (Null responder: received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 IU/mL reduction in HCV RNA at Week 12; Partial responders: received at least 20 weeks of pegIFN/RBV for the treatment of HCV and achieved ≥ 2 log10 IU/mL reduction in HCV RNA at Week 12, but failed to achieve HCV RNA undetectable (HCV RNA < lower limit of detection [< LLOD]) at the end of treatment; Relapsers: received at least 1 course of pegIFN/RBV for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was detectable within 24 weeks of treatment follow-up).

Exclusion Criteria:

  • Significant liver disease with any cause other than HCV as the primary cause
  • Positive screen for drugs or alcohol.
  • Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
  • Use of contraindicated medications within 2 weeks of dosing
  • Previous use of any investigational or commercially available anti-Hepatitis C virus agent other than pegIFN/RBV, including previous exposure to ABT-450 or ABT-267.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 2
Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 3
Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 4
Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 5
Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 6
Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)
Time Frame: 24 weeks after last dose of study drug
The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.
24 weeks after last dose of study drug
Number of Participants With Adverse Events (AEs)
Time Frame: TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.
TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)
Time Frame: 12 weeks after last dose of study drug
The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.
12 weeks after last dose of study drug
Percentage of Participants With End of Treatment (EOT) Response
Time Frame: 12 or 24 weeks after first dose of study drug
The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.
12 or 24 weeks after first dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Takuma Matsuda, MS, AbbVie GK.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 27, 2012

First Submitted That Met QC Criteria

August 23, 2012

First Posted (Estimate)

August 27, 2012

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-536

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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