Clinical trial NCT01854697: A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before
Official title: A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With and Without Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon α-2a and Ribavirin in Treatment-Naïve Adults With Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Infection
Keywords: Chronic Hepatitis C
Interferon Free
Hepatitis C Treatment Naive
Hepatitis C Virus
Hepatitis C Genotype 1
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.

Detailed description: The primary purpose of this study is to demonstrate that treatment with ABT-450/ritonavir (r)/ABT-267 and ABT-333 administered with or without ribavirin (RBV) has non-inferior efficacy compared to treatment with telaprevir and pegylated interferon alpha-2a (pegIFN) and RBV and to compare the safety of these regimens in treatment-naive hepatitis C virus (HCV) genotype (GT) 1a- and 1b-infected adults.

Eligibility criteria: Inclusion Criteria:

* Males or females between 18 and 65 years, inclusive, at time of Screening
* Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control
* Subject has never received antiviral treatment for hepatitis C infection
* Chronic HCV Genotype-1 infection prior to study enrollment

Exclusion Criteria:

* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab)
* Females who are pregnant or plan to become pregnant, or breastfeeding
* Any current or past clinical evidence of cirrhosis
* Screening laboratory analyses that showing abnormal laboratory results
* Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for telaprevir, pegIFN and RBV
* Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol
* Positive screen for drugs or alcohol

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses
timeFrame: 12 weeks after the last actual dose of active study drug
Secondary outcomes:
measure: Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)
timeFrame: From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E
measure: Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)
timeFrame: From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E
measure: Percentage of Participants With SVR12 - Secondary Efficacy Analyses
timeFrame: 12 weeks after the last actual dose of active study drug
measure: Percentage of Participants With Virologic Failure During Treatment
timeFrame: 12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: Within 24 weeks post treatment
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)
timeFrame: 24 weeks after the last actual dose of active study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Yan Luo, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Dore GJ, Conway B, Luo Y, Janczewska E, Knysz B, Liu Y, Streinu-Cercel A, Caruntu FA, Curescu M, Skoien R, Ghesquiere W, Mazur W, Soza A, Fuster F, Greenbloom S, Motoc A, Arama V, Shaw D, Tornai I, Sasadeusz J, Dalgard O, Sullivan D, Liu X, Kapoor M, Campbell A, Podsadecki T. Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials. J Hepatol. 2016 Jan;64(1):19-28. doi: 10.1016/j.jhep.2015.08.015. Epub 2015 Aug 29.