A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection

NCT ID: NCT01685203

Last Updated: 2021-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-02-28

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.

Detailed Description

This was a Phase 2, randomized, open-label, combination treatment study of the 2-DAA regimen (ABT-450 150 mg QD + ritonavir 100 mg QD + ABT-267 25 mg QD) in adult HCV GT1b-infected treatment-naïve and Pegylated-interferon/ribavirin (pegIFN/RBV) treatment-experienced participants without cirrhosis and with compensated cirrhosis, and in adult GT4-infected treatment-naïve and pegIFN/RBV treatment-experienced participants without cirrhosis. Treatment Group 5 was not open to enrollment, based on a protocol-specified interim review of results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher sustained virologic response (SVR) rates among participants receiving the 2-DAA regimen with RBV. All other groups completed the study.

Conditions

Hepatitis C, Chronic

Study Design

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

Study Groups

Group 1

ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants

Group Type: EXPERIMENTAL

ABT-450/r

Intervention Type: DRUG

Tablet; ABT-450; Capsule; ritonavir

ABT-267

Intervention Type: DRUG

Tablet

Group 2

ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants

Group Type: EXPERIMENTAL

ABT-450/r

Intervention Type: DRUG

Tablet; ABT-450; Capsule; ritonavir

ABT-267

Intervention Type: DRUG

Tablet

Group 3

ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants

Group Type: EXPERIMENTAL

ABT-450/r

Intervention Type: DRUG

Tablet; ABT-450; Capsule; ritonavir

ABT-267

Intervention Type: DRUG

Tablet

Group 4

ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants

Group Type: EXPERIMENTAL

ABT-450/r

Intervention Type: DRUG

Tablet; ABT-450; Capsule; ritonavir

ABT-267

Intervention Type: DRUG

Tablet

Ribavirin (RBV)

Intervention Type: DRUG

Tablet

Group 5

ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-experienced, HCV GT4-infected participants

Group Type: EXPERIMENTAL

ABT-450/r

Intervention Type: DRUG

Tablet; ABT-450; Capsule; ritonavir

ABT-267

Intervention Type: DRUG

Tablet

Group 6

ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants

Group Type: EXPERIMENTAL

ABT-450/r

Intervention Type: DRUG

Tablet; ABT-450; Capsule; ritonavir

ABT-267

Intervention Type: DRUG

Tablet

Ribavirin (RBV)

Intervention Type: DRUG

Tablet

Group 7

ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis

Group Type: EXPERIMENTAL

ABT-450/r

Intervention Type: DRUG

Tablet; ABT-450; Capsule; ritonavir

ABT-267

Intervention Type: DRUG

Tablet

Group 8

ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis

Group Type: EXPERIMENTAL

ABT-450/r

Intervention Type: DRUG

Tablet; ABT-450; Capsule; ritonavir

ABT-267

Intervention Type: DRUG

Tablet

Interventions

ABT-450/r

Tablet; ABT-450; Capsule; ritonavir

Intervention Type: DRUG

ABT-267

Tablet

Intervention Type: DRUG

Ribavirin (RBV)

Tablet

Intervention Type: DRUG

Other Intervention Names

ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir

Eligibility Criteria

Inclusion Criteria

• Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
• Subjects must meet one of the following:

• Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
• Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegIFN/RBV);
• Body mass index (BMI) is ≥ 18 to < 38 kg/m^2.
• Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
• Subject has plasma HCV RNA level > 10,000 IU/mL at Screening

Exclusion Criteria

• History of severe, life-threatening or other significant sensitivity to any drug.
• Females who were pregnant or planned to become pregnant, or breastfeeding, or GT4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV.
• Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
• Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nilou Mobashery, MD

Role: STUDY_DIRECTOR

AbbVie

References

Hezode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, Marcellin P, Hall C, Schnell G, Pilot-Matias T, Mobashery N, Redman R, Vilchez RA, Pol S. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015 Jun 20;385(9986):2502-9. doi: 10.1016/S0140-6736(15)60159-3. Epub 2015 Mar 31.

Reference Type: BACKGROUND

PMID: 25837829 (View on PubMed)

Lawitz E, Makara M, Akarca US, Thuluvath PJ, Preotescu LL, Varunok P, Morillas RM, Hall C, Mobashery N, Redman R, Pilot-Matias T, Vilchez RA, Hezode C. Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-Label Study of Patients With Genotype 1b Chronic Hepatitis C Virus Infection With and Without Cirrhosis. Gastroenterology. 2015 Oct;149(4):971-80.e1. doi: 10.1053/j.gastro.2015.07.001. Epub 2015 Jul 11.

Reference Type: BACKGROUND

PMID: 26170136 (View on PubMed)

Related Links

http://www.rxabbvie.com

Related Info

Other Identifiers

2011-005762-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-393

Identifier Type: -

Identifier Source: org_study_id