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A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients

NCT ID: NCT01782495

Last Updated: 2017-11-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-25

Study Completion Date

2017-07-13

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4) infection.

Detailed Description

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Conditions

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Chronic Hepatitis C Infection

Keywords

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Hepatitis C Genotype 4 Chronic Hepatitis Interferon-Free Hepatitis C Virus (HCV) Renal Transplant Liver Transplant Hepatitis C Genotype 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

ribavirin

Intervention Type DRUG

tablet

Arm B

Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

ribavirin

Intervention Type DRUG

tablet

Arm C

Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Arm D

Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

ribavirin

Intervention Type DRUG

tablet

Arm E

Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

ribavirin

Intervention Type DRUG

tablet

Arm F

Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

ribavirin

Intervention Type DRUG

tablet

Arm G

Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Arm H

Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

ribavirin

Intervention Type DRUG

tablet

Arm I

Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Arm J

Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

ribavirin

Intervention Type DRUG

tablet

Arm K

Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

ribavirin

Intervention Type DRUG

tablet

Interventions

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ombitasvir/paritaprevir/ritonavir and dasabuvir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Intervention Type DRUG

ombitasvir/paritaprevir/ritonavir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

Intervention Type DRUG

ribavirin

tablet

Intervention Type DRUG

Other Intervention Names

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Viekira Pak paritaprevir also known as ABT-450 ombitasvir also known as ABT-267 dasabuvir also known as ABT-333 TECHNIVIE paritaprevir also known as ABT-450 ombitasvir also known as ABT-267

Eligibility Criteria

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Inclusion Criteria

* Male or female, at least 18 years of age at the time of screening.
* Currently taking an immunosuppressant regimen based on either tacrolimus or cyclosporine. Corticosteroids such as prednisone or prednisolone are permitted as components of the immunosuppressant regimen providing the dose is not more than 10 mg/day.
* Hepatitis C virus (HCV) interferon (IFN) therapy treatment-naïve or -experienced, either pre- or post-liver or renal transplant.
* Screening HCV genotype testing indicating infection with genotype 1 or 4 (GT1 or GT4) only.

Exclusion Criteria

* Use of everolimus or sirolimus as part of the immunosuppressive regimen within 2 months of Screening Visit.
* Use of any medications contraindicated for use with the study regimen as well as those that are contraindicated for use with either ritonavir or ribavirin within 2 weeks prior to study drugs administration or 10 half-lives (if known), whichever is longer.
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
* Documented history of post-transplant complications directly involving the hepatic or renal vasculature as appropriate to the organ transplanted, e.g., thrombosis of the portal vein, the hepatic artery and/or hepatic vein.
* Clinically significant abnormalities, other than HCV infection, in a subject post-transplant based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc

Role: STUDY_DIRECTOR

AbbVie

Countries

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Australia France Germany Puerto Rico Spain United Kingdom United States

References

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Kwo PY, Mantry PS, Coakley E, Te HS, Vargas HE, Brown R Jr, Gordon F, Levitsky J, Terrault NA, Burton JR Jr, Xie W, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Forns X. An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med. 2014 Dec 18;371(25):2375-82. doi: 10.1056/NEJMoa1408921. Epub 2014 Nov 11.

Reference Type DERIVED
PMID: 25386767 (View on PubMed)

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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2012-004792-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M12-999

Identifier Type: -

Identifier Source: org_study_id