A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults

NCT ID: NCT01854528

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-07-31

Brief Summary

The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267; ABT-267 also known as ombitasvir] and ABT-333 [also known as dasabuvir]) plus ribavirin (RBV) compared with telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

Detailed Description

A randomized, open-label, parallel-arm, multicenter study to evaluate the safety and antiviral activity of the 3-DAA regimen (ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267] and ABT-333) plus ribavirin (3-DAA/RBV) compared with the combination of telaprevir (TPV) with RBV and pegIFN (TPV/RBV) in noncirrhotic participants with chronic hepatitis C virus genotype 1 (HCV GT1) infection who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

Participants were randomized in a 2:1 ratio to receive 3-DAA/RBV (ABT-450/r/ABT-267 and ABT-333 plus RBV for 12 weeks) or TPV/RBV (TPV co-administered with pegIFN and RBV for 12 weeks, followed by followed by pegIFN and RBV for either 12 or 36 weeks, per local prescribing information).

Conditions

Chronic Hepatitis C Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3-DAA/RBV

3-DAA (ABT-450/r/ABT-267 \[150 mg/ 100 mg/ 25 mg once daily\] and ABT-333 \[250 mg twice daily\]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Ribavirin

Intervention Type: DRUG

Tablet

TPV/RBV

TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously \[SC\] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.

Group Type: ACTIVE_COMPARATOR

Ribavirin

Intervention Type: DRUG

Tablet

Pegylated Interferon a-2a (PegINF)

Intervention Type: DRUG

Pre-filled syringe

Telaprevir

Intervention Type: DRUG

Film-coated tablet

Interventions

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

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

Intervention Type: DRUG

Ribavirin

Tablet

Intervention Type: DRUG

Pegylated Interferon a-2a (PegINF)

Pre-filled syringe

Intervention Type: DRUG

Telaprevir

Film-coated tablet

Intervention Type: DRUG

Other Intervention Names

ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ABT-333 also known as dasabuvir; Viekira PAK

Eligibility Criteria

Inclusion Criteria

• Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
• Chronic hepatitis C infection (positive for anti-HCV antibody or HCV RNA at least 6 months before screening and at the time of screening; or positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection)
• Screening laboratory result indicating HCV genotype 1 infection (HCV GT1)
• Participant 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 cirrhosis

Exclusion Criteria

• Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
• Positive screen for drugs or alcohol
• Significant sensitivity to any drug
• Use of contraindicated medications within 2 weeks of dosing
• Abnormal laboratory tests

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Luo, MD

Role: STUDY_DIRECTOR

AbbVie

References

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.

Reference Type: RESULT

PMID: 26321288 (View on PubMed)

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

2012-003738-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-862

Identifier Type: -

Identifier Source: org_study_id