Overview

This trial is active, not recruiting.

Condition chronic hepatitis c virus
Treatments abt-450/r/abt-267, placebo, abt-333
Phase phase 3
Sponsor AbbVie
Start date July 2015
End date June 2017
Trial size 640 participants
Trial identifier NCT02517515, M13-767

Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced adults with subgenotype 1b chronic HCV.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Double-blind ABT-450/r/ABT-267 once daily (QD) + ABT-333 twice daily (BID) for 12 weeks
abt-450/r/abt-267 Paritaprevir/Ritonavir/Ombitasvir
Tablet
abt-333 Dasabuvir
Tablet
(Experimental)
Double-blind placebo for ABT-450/r/ABT-267 QD + placebo for ABT-333 mg BID for 12 weeks followed by open-label ABT-450/r/ABT-267 QD + ABT-333 BID for 12 weeks
placebo
Placebo for ABT-450/r/ABT-267
placebo
Placebo for ABT-333

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 GT 1b infection. 4. Per local standard practice, documented results of one of the following: - Liver biopsy within 24 months prior to or during screening demonstrating the absence of cirrhosis, e.g., a Metavir Score of ≤ 3 or an Ishak score of ≤ 4; or - A screening FibroTest score of ≤ 0.72 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 2; or - A screening FibroScan result of < 9.6 kPa. (Participants with a non-qualifying FibroTest/APRI or FibroScan result may only be enrolled if they have a qualifying liver biopsy performed within 24 months prior to or during screening.) 5. Participant has never received antiviral treatment (including IFN-based therapy [IFN (alpha, beta or pegIFN) with or without RBV]) for hepatitis C 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 6. Participant has plasma HCV RNA level > 10,000 IU/mL at Screening. 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. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis, e.g., a Metavir score of > 3 or Ishak score of > 4. 4. 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. 5. Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function. 6. 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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.