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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01854697
• Date of registration: 08/04/2013
• Prospective Registration: No
• Primary sponsor: AbbVie
• Public title: 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 MALACHITE 1
• Scientific 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 a-2a and Ribavirin in Treatment-Naïve Adults With Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE I)
• Date of first enrolment: March 2013
• Target sample size: 311
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01854697
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Canada, Chile, Finland, Hungary, Norway, Poland, Romania, Slovakia

Contacts

• Name: Yan Luo, MD, PhD
• Affiliation: AbbVie

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C Infection

Intervention(s)

Drug: Ribavirin

Drug: Telaprevir

Drug: ABT-450/r/ABT-267, ABT-333

Drug: Pegylated Interferon alpha 2-a (PegIFN)

Primary Outcome(s)

Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses [Time Frame: 12 weeks after the last actual dose of active study drug]

Secondary Outcome(s)

Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS) [Time Frame: 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]

Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24) [Time Frame: 24 weeks after the last actual dose of active study drug]

Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS) [Time Frame: 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]

Percentage of Participants With Virologic Failure During Treatment [Time Frame: 12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E]

Percentage of Participants With Post-treatment Relapse [Time Frame: Within 24 weeks post treatment]

Percentage of Participants With SVR12 - Secondary Efficacy Analyses [Time Frame: 12 weeks after the last actual dose of active study drug]

Secondary ID(s)

M13-774

2012-003754-84

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/02/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01854697