A randomized, open-labeled study to evaluate the efficacy and safety of three experimental drugs (ABT-450, ABT-267 and ABT-333) compared with Telaprevir (a licenced product) in people with hepatitis C virus (HCV) who have previously tried and failed other treatments. "Experimental" means that they have not been approved by any regulatory agency for sale to the public.

A Randomized, Open-Labeled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered with Ribavirin Compared to Telaprevir Co-administered with Pegylated Interferon a-2a and Ribavirin in Treatment-Experienced Adults with Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE II)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003738-18-HU

Enrollment

150

Registered

2013-03-05

Start date

2013-04-26

Completion date

Unknown

Last updated

2015-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: ABT-450/ritonavir/ABT-267 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ABT-450 Current Sponsor code: ABT-450 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Males or females 18 to 65 years old, inclusive Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control Chronic hepatitis C, genotype 1-infection Subject must have documentation of adherence to a prior pegIFN/RBV combination therapy and meet one of the protocol definitions for treatment failure: null responder, partial responder, relapser No evidence of liver cirhhosis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Positive screen for drugs or alcohol Significant sensitivity to any drug Use of contraindicated medications within 2 weeks of dosing Abnormal laboratory tests Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the efficacy (the percentage of subjects achieving 12-week sustained virologic response, SVR12, [HCV RNA < LLOQ 12 weeks post-treatment]) and safety of ABT-450/r/ABT-267 and ABT-333 co-administered with RBV for 12 weeks compared to 12 weeks of treatment with telaprevir and pegIFN/RBV followed by either 12 weeks or 36 weeks of pegIFN/RBV, per local prescribing information, in treatment-experienced HCV genotype 1-infected adults.;Secondary Objective: The secondary objectives of this study are to compare the following health-related quality of life and efficacy measures between the two treatment arms: ? the general health-related quality of life using the SF-36 Mental Component Summary scores, ? the general health-related quality of life using the SF-36 Physical Component Summary scores, ? the percentage of subjects with 24-week sustained virologic response rate (SVR24) (the percentage of subjects with HCV RNA < LLOQ 24 weeks following treatment), and ? the percentage of subjects with virologic failure during treatment, and the percentage of subjects with post-treatment relapse.;Primary end point(s): The primary endpoint is the percentage of subjects with SVR12. ;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drugs	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the efficacy (the percentage of subjects achieving 12-week sustained virologic response, SVR12, [HCV RNA < LLOQ 12 weeks post-treatment]) and safety of ABT-450/r/ABT-267 and ABT-333 co-administered with RBV for 12 weeks compared to 12 weeks of treatment with telaprevir and pegIFN/RBV followed by either 12 weeks or 36 weeks of pegIFN/RBV, per local prescribing information, in treatment-experienced HCV genotype 1-infected adults.;Secondary Objective: The secondary objectives of this study are to compare the following health-related quality of life and efficacy measures between the two treatment arms: ? the general health-related quality of life using the SF-36 Mental Component Summary scores, ? the general health-related quality of life using the SF-36 Physical Component Summary scores, ? the percentage of subjects with 24-week sustained virologic response rate (SVR24) (the percentage of subjects with HCV RNA < LLOQ 24 weeks following treatment), and ? the percentage of subjects with virologic failure during treatment, and the percentage of subjects with post-treatment relapse.;Primary end point(s): The primary endpoint is the percentage of subjects with SVR12. ;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drugs

—

Secondary

Measure	Time frame
Secondary end point(s): a. QOL assessed by SF-36 instrument b. Percentage of subjects with SVR24 c. Percentage of subjects with virologic failure during treatment and with post-treatment relapse;Timepoint(s) of evaluation of this end point: a. 12 weeks after first dose of study drug b. 24 weeks after last dose of study drug c. 12 weeks after first dose of study drug	—

Countries

Argentina, Brazil, Chile, Finland, Hungary, Poland, Romania, Slovakia

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd.

eu-clinical-trials@abbvie.com+44162877 4695

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026