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

Chronic Hepatitis C Infection Clinical Trial

— MALACHITE 1  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854697
• Other study ID #: M13-774
• Secondary ID: 2012-003754-84
• Status: Completed
• Phase: Phase 3
• Start date: March 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: July 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• Virus Diseases

Intervention

Drug:
• ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
• Ribavirin
Tablet
• Telaprevir
Film-coated tablet
• Pegylated Interferon alpha 2-a (PegIFN)
Pre-filled syringe

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & Publications (1)

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, Camp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses	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.	12 weeks after the last actual dose of active study drug
Secondary	Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)	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).	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
Secondary	Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)	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).	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
Secondary	Percentage of Participants With SVR12 - Secondary Efficacy Analyses	The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug.	12 weeks after the last actual dose of active study drug
Secondary	Percentage of Participants With Virologic Failure During Treatment	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.	12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E
Secondary	Percentage of Participants With Post-treatment Relapse	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.	Within 24 weeks post treatment
Secondary	Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)	The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 24 weeks after the last dose of study drug.	24 weeks after the last actual dose of active study drug

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