Clinical trial NCT02517528: ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
Official title: An Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Treatment-Naïve and Treatment-Experienced Asian Adults With GT1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Virus (HCV)
Keywords: HCV Infection
Compensated Cirrhosis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-08-07
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced Asian adults with compensated cirrhosis.


Eligibility criteria: Inclusion Criteria:

1. Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage.
2. Chronic HCV-infection prior to study enrollment.
3. Screening laboratory result indicating HCV genotype 1b-infection.
4. Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening.
5. Per local standard practice, documentation of cirrhosis by one of the following methods:

   * Diagnosis on previous liver biopsy or liver biopsy conducted during screening e.g., Metavir Score of \> 3 (including 3/4 or 3 - 4), Ishak score of \> 4 or,
   * FibroScan score ≥ 14.6 kiloPascals (kPa) within 6 months of Screening or during the Screening Period.

Exclusion Criteria:

1. HCV genotype performed during screening indicating unable to genotype or infection with any other HCV genotype.
2. Positive test result at Screening for Hepatitis B surface antigen (HBsAg), or hepatitis B virus (HBV) DNA \> Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-Human Immunodeficiency virus antibody (HIV Ab).
3. Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of CYP2C8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
4. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
5. Serum Alpha-Fetoprotein (sAFP) \> 100 ng/mL at Screening.
6. Confirmed presence of hepatocellular carcinoma (HCC) indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result should be confirmed with CT scan or MRI.)
7. Any primary cause of liver disease other than chronic HCV-infection, including but not limited to the following:

   * Hemochromatosis
   * Alpha-1 antitrypsin deficiency
   * Wilson's disease
   * Autoimmune hepatitis
   * Alcoholic liver disease
   * Drug-related liver disease Steatosis and steatohepatitis on a liver biopsy coincident with HCV-related changes would not be considered exclusionary unless the steatohepatitis is considered to be the primary cause of the liver disease.
8. Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
timeFrame: 12 weeks after last dose of study drug
measure: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
timeFrame: 24 weeks after last dose of study drug
Secondary outcomes:
measure: Percentage of Participants With On Treatment Virologic Failure
timeFrame: Within 12 weeks after first dose of study drug
measure: Percentage of Participants With Virologic Relapse
timeFrame: Within 12 weeks after the last dose of study drug
measure: Percentage of Participants With Virologic Relapse by Post-Treatment Week 24
timeFrame: Within 24 weeks after the last dose of 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.