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

NCT01854697 | Completed Phase 3 Results

• 2 other identifiers: M13-7742012-003754-84
• Study Type: interventional
• Target: 311
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Hepatitis C Infection

Keywords

Chronic Hepatitis C; Interferon Free; Hepatitis C Treatment Naive; Hepatitis C Virus; Hepatitis C Genotype 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  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

• Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)

  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 SVR12 - Secondary Efficacy Analyses

  12 weeks after the last actual dose of active study drug

• Percentage of Participants With Virologic Failure During Treatment

  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

  Within 24 weeks post treatment

Study Arms (5)

Arm A: 3-DAA + RBV in GT1a

EXPERIMENTAL

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; Drug: Ribavirin

Arm B: TPV/PR in GT1a

ACTIVE COMPARATOR

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; Drug: Telaprevir; Drug: Pegylated Interferon alpha 2-a (PegIFN)

Arm C: 3-DAA + RBV in GT1b

EXPERIMENTAL

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; Drug: Ribavirin

Arm D: 3-DAA in GT1b

EXPERIMENTAL

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

Arm E: TPV/PR in GT1b

ACTIVE COMPARATOR

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; Drug: Telaprevir; Drug: Pegylated Interferon alpha 2-a (PegIFN)

Interventions

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

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

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

Arm A: 3-DAA + RBV in GT1a; Arm C: 3-DAA + RBV in GT1b; Arm D: 3-DAA in GT1b

Ribavirin DRUG

Tablet

Arm A: 3-DAA + RBV in GT1a; Arm B: TPV/PR in GT1a; Arm C: 3-DAA + RBV in GT1b; Arm E: TPV/PR in GT1b

Telaprevir DRUG

Film-coated tablet

Arm B: TPV/PR in GT1a; Arm E: TPV/PR in GT1b

Pegylated Interferon alpha 2-a (PegIFN) DRUG

Pre-filled syringe

Arm B: TPV/PR in GT1a; Arm E: TPV/PR in GT1b

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related 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, Campbell A, Podsadecki T. Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials. J Hepatol. 2016 Jan;64(1):19-28. doi: 10.1016/j.jhep.2015.08.015. Epub 2015 Aug 29.

  PMID: 26321288 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

dasabuvir; Viekira Pak; ombitasvir; paritaprevir; Ribavirin; telaprevir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

800-633-9110

Study Officials

• Yan Luo, MD, PhD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: May 15, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: July 1, 2015
• Last Updated: June 6, 2018
• Results First Posted: February 22, 2016

Record last verified: 2016-07