This trial is active, not recruiting.

Condition chronic hepatitis c virus
Treatments abt-450/r/abt-267, abt-333, ribavirin
Phase phase 3
Sponsor AbbVie
Start date July 2015
End date September 2016
Trial size 100 participants
Trial identifier NCT02517528, M14-491


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 ribavirin (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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
abt-450/r/abt-267 Paritaprevir/Ritonavir/Ombitasvir
abt-333 Dasabuvir

Primary Outcomes

Percentage of participants Achieving Sustained Virologic Response (SVR) 12 Weeks Post-treatment
time frame: 12 weeks after last dose of study drug
Percentage of participants Achieving Sustained Virologic Response (SVR) 24 Weeks Post-treatment
time frame: 24 weeks after last dose of study drug

Secondary Outcomes

Percentage of participants with on treatment virologic failure
time frame: Within 12 weeks after first dose of study drug
Percentage of participants with virologic relapse by post-treatment Week 12
time frame: Within 12 weeks after the last dose of study drug
Percentage of participants with virologic relapse by post-treatment Week 24
time frame: Within 24 weeks after the last dose of study drug

Eligibility Criteria

All participants from 18 years up to 70 years old.

Inclusion Criteria

  • Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage.
  • Chronic HCV-infection prior to study enrollment.
  • Screening laboratory result indicating HCV genotype 1b-infection.
  • Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening.
  • 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 kPa within 6 months of Screening or during the Screening Period.

Exclusion Criteria

  • HCV genotype performed during screening indicating unable to genotype or infection with any other HCV genotype.
  • Positive test result at Screening for Hepatitis B surface antigen (HBsAg), or HBV DNA > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-Human Immunodeficiency virus antibody (HIV Ab).
  • 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.
  • 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.
  • Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.
  • 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.)
  • 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.
  • Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.

Additional Information

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
Principal investigator Yan Luo, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by AbbVie.