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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)

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ClinicalTrials.gov Identifier: NCT01854697
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : February 22, 2016
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: ABT-450/r/ABT-267, ABT-333 Drug: Ribavirin Drug: Telaprevir Drug: Pegylated Interferon alpha 2-a (PegIFN) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: 3-DAA + RBV in GT1a
ABT-450/r/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based RBV for 12 weeks (3 direct-acting antivirals [DAAs] with RBV in GT1a)
Drug: ABT-450/r/ABT-267, ABT-333
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

Drug: Ribavirin
Tablet

Active Comparator: Arm B: TPV/PR in GT1a
Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegIFN 180 µg/week and weight-based RBV (PR) for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
Drug: Ribavirin
Tablet

Drug: Telaprevir
Film-coated tablet

Drug: Pegylated Interferon alpha 2-a (PegIFN)
Pre-filled syringe

Experimental: Arm C: 3-DAA + RBV in GT1b
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
Drug: ABT-450/r/ABT-267, ABT-333
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

Drug: Ribavirin
Tablet

Experimental: Arm D: 3-DAA in GT1b
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
Drug: ABT-450/r/ABT-267, ABT-333
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

Active Comparator: Arm E: TPV/PR in GT1b
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Drug: Ribavirin
Tablet

Drug: Telaprevir
Film-coated tablet

Drug: Pegylated Interferon alpha 2-a (PegIFN)
Pre-filled syringe




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854697


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Yan Luo, MD, PhD AbbVie

Additional Information:
Publications of Results:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01854697     History of Changes
Other Study ID Numbers: M13-774
2012-003754-84 ( EudraCT Number )
First Posted: May 15, 2013    Key Record Dates
Results First Posted: February 22, 2016
Last Update Posted: June 5, 2018
Last Verified: July 2016

Keywords provided by AbbVie:
Chronic Hepatitis C
Interferon Free
Hepatitis C Treatment Naive
Hepatitis C Virus
Hepatitis C Genotype 1

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Interferon alpha-2
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs