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Completed

NCT Number: 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

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.

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Key information

Conditions

Chronic Hepatitis C Infection Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Other names: Viekira Pak, ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ABT-333 also known as dasabuvir, Holkira Pak

Ribavirin

Drug

Tablet

Telaprevir

Drug

Film-coated tablet

Pegylated Interferon alpha 2-a (PegIFN)

Drug

Pre-filled syringe

Primary outcomes

  1. 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

    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.

Secondary outcomes

  1. 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

    SF-36V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and MCS; it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).

  2. 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

    SF-36V2 is a generic 36-item questionnaire measuring HRQoL covering 2 summary measures: PCS and MCS; it consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Participants self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).

  3. Percentage of Participants With SVR12 - Secondary Efficacy Analyses

    Time frame: 12 weeks after the last actual dose of active study drug

    The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug.

  4. 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

    Participants in Arms A, C or D demonstrating any of the following were considered virologic failures and discontinued therapy:

    • Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point during treatment
    • Failure to achieve HCV RNA < LLOQ by Week 6 or
    • Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point after HCV RNA < LLOQ during treatment after HCV RNA < LLOQ.

    Participants in Arms B and E followed virologic stopping criteria described in the TPV Summary of Product Characteristics; they were considered virologic failures and discontinued therapy as follows:

    • HCV RNA > 1000 IU/mL at Week 4 to Week 12, discontinue TPV and pegIFN and RBV
    • HCV RNA > 1000 IU/mL at Week 12, discontinue pegIFN and RBV
    • Confirmed HCV RNA > lower limit of detection (LLOD) at Week 24, discontinue pegIFN and RBV
    • Confirmed HCV RNA > LLOD at Week 36, discontinue pegIFN and RBV.

  5. Percentage of Participants With Post-treatment Relapse

    Time frame: Within 24 weeks post treatment

    Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (LLOQ) between the end of treatment and 24 weeks post treatment among participants completing treatment and with HCV RNA less than the LLOQ at the end of treatment.

  6. 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

    The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 24 weeks after the last dose of study drug.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: MALACHITE 1

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 15, 2013
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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