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ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

NCT ID: NCT02517515

Last Updated: 2017-10-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-06-30

Brief Summary

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This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.

Detailed Description

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Conditions

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Hepatitis C Virus (HCV)

Keywords

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HCV Infection Chronic Hepatitis C Virus Hepatitis C Virus (HCV) Genotype 1b

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Double-blind 3-DAA

Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Double-blind Placebo Followed by Open-label 3-DAA

Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Interventions

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ombitasvir/paritaprevir/ritonavir and dasabuvir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Intervention Type DRUG

Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Other Intervention Names

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Viekira Pak paritaprevir also known as ABT-450 ombitasvir also known as ABT-267 dasabuvir also known as ABT-333

Eligibility Criteria

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Inclusion Criteria

* Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage
* Chronic hepatitis C virus (HCV) infection prior to study enrollment.
* Screening laboratory result indicating HCV subtype 1b (GT1b) infection.
* Per local standard practice, documented absence of cirrhosis.
* Participant has never received antiviral treatment (including interferon \[IFN\]-based therapy \[alpha, beta or pegylated (peg)IFN\] with or without RBV) for HCV infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): Non-responder or Relapser
* Participant has plasma HCV RNA level \> 10,000 IU/mL at Screening.

Exclusion Criteria

* HCV genotype performed during screening indicating unable to genotype or infection with any HCV genotype other than GT1b.
* Positive test result at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B virus DNA (HBV-DNA) \> Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.
* Any current or past clinical evidence of cirrhosis.
* Any primary cause of liver disease other than chronic HCV infection.
* Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
* Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Countries

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China South Korea Taiwan

References

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Zha J, Ding B, Wang H, Zhao W, Yu C, Alves K, Mobashery N, Luo Y, Menon RM. Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients. Eur J Drug Metab Pharmacokinet. 2019 Feb;44(1):43-52. doi: 10.1007/s13318-018-0492-8.

Reference Type DERIVED
PMID: 29909549 (View on PubMed)

Related Links

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http://www.rxabbvie.com/

Related Info.

Other Identifiers

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M13-767

Identifier Type: -

Identifier Source: org_study_id