Clinical trial NCT02517515: 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
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus (HCV)
Keywords: HCV Infection
Chronic Hepatitis C Virus
Hepatitis C Virus (HCV) Genotype 1b
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-08-07
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of active study drug
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
timeFrame: 24 weeks after the last actual dose of active study drug
Secondary outcomes:
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: up to 12 weeks
measure: Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12
timeFrame: From the end of treatment through 12 weeks after the last dose of active study drug
measure: Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24
timeFrame: From the end of treatment through 24 weeks after the last dose of active study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.