Overview

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

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 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

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 Paritapravir/Ritonavir/Ombitasvir
Tablet
abt-333 Dasabuvir
Tablet
ribavirin
Tablet

Primary Outcomes

Measure
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

Measure
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

Male or female participants from 18 years up to 70 years old.

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 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 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.

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 Genotype 1b 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 November 2016.
Information provided to ClinicalTrials.gov by AbbVie.