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

This study is currently recruiting participants.

Verified June 2013 by AbbVie

Sponsor:

AbbVie

Information provided by (Responsible Party):

AbbVie

ClinicalTrials.gov Identifier:

NCT01782495

First received: January 22, 2013

Last updated: June 27, 2013

Last verified: June 2013

Purpose

This is a study to evaluate chronic Hepatitis C Virus infection.

Condition	Intervention	Phase
Chronic Hepatitis C Infection	Drug: ABT-450/r/ABT-267 Drug: ABT-333 Drug: ribavirin (RBV)	Phase 2

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-label, Single Arm, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adult Liver Transplant Recipients With Genotype 1 Hepatitis C Virus (HCV) Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C Liver Transplantation

Drug Information available for: Ribavirin Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

• Percentage of subjects with sustained virologic response 12 weeks post-treatment [ Time Frame: 12 weeks after the last actual dose of study drug ] [ Designated as safety issue: No ]
  Hepatitis C virus ribonucleic acid less than the lower limit of quantification

Secondary Outcome Measures:

• Percentage of subjects with sustained virologic response 24 weeks post treatment [ Time Frame: 24 weeks after the last actual dose of study drug ] [ Designated as safety issue: No ]
  Hepatitis C virus ribonucleic acid less than the lower limit of quantification
• Percentage of subjects with virologic failure during treatment [ Time Frame: Treatment Day 1 up to 24 weeks ] [ Designated as safety issue: No ]
  Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification, after HCV RNA less than the lower limit of quantification or HCV RNA greater than or equal to the lower limit of quantification at the end of treatment
• Percentage of subjects with post-treatment relapse [ Time Frame: Within 12 weeks post treatment ] [ Designated as safety issue: No ]
  Hepatitis C Virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification between the end of treatment and 12 weeks post treatment among subjects completing treatment and with HCV RNA less than the lower limit of quantification at the end of treatment
  

Estimated Enrollment:	30
Study Start Date:	February 2013
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ARM A ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 24 weeks	Drug: ABT-450/r/ABT-267 tablet Drug: ABT-333 tablet Drug: ribavirin (RBV) tablet

Detailed Description:

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir, ABT-267 (ABT-450/r/ABT-267) and ABT-333 co-administered with ribavirin in adult liver transplant recipients with hepatitis C virus (HCV) infection.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Males and females 18-70 years old, inclusive.
• Liver transplantation as a consequence of HCV infection no less than 12 months before screening.
• Must have a liver biopsy which shows evidence of fibrosis <= F2 (Metavir scale) and which is obtained within the 6 months prior to the screening period but not less than 9 months post transplant or during the Screening Period
• Chronic hepatitis C genotype 1 infection.
• On an immunosuppressant regimen based on either tacrolimus or cyclosporine where the dose of immunosuppressant has not been increased at least 2 months before Screening and no new immunosuppressant drugs have been added for at leas 2 months before Screening.

Exclusion Criteria:

• Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody.
• Use of contraindicated medications within 2 weeks of dosing or 10 half-lives, whichever is longer.
• Clinically significant abnormalities, other than HCV infection post transplant.
• Recent history of drug or alcohol abuse.
• Previous use of any investigational or commercially available anti-HCV agent other than interferon (IFN)-based therapy, i.e. conventional (c) IFN and/or pegylated (Peg) IFN, with or without RBV

.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782495

Contacts

Contact: Melissa Cook, MS	847-937-1399	melissa.cook@abbvie.com
Contact: Jennifer Moseley, BS	847-938-1394	jennifer.r.moseley@abbvie.com

Locations

United States, Arizona
Site Reference ID/Investigator# 90539	Recruiting
Phoenix, Arizona, United States, 85054
Principal Investigator: Site Reference ID/Investigator# 90539
United States, Colorado
Site Reference ID/Investigator# 90535	Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Site Reference ID/Investigator# 90535
United States, Illinois
Site Reference ID/Investigator# 90562	Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Site Reference ID/Investigator# 90562
Site Reference ID/Investigator# 90563	Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Site Reference ID/Investigator# 90563
United States, Indiana
Site Reference ID/Investigator# 90536	Recruiting
Indianapolis, Indiana, United States, 46202-5121
Principal Investigator: Site Reference ID/Investigator# 90536
United States, Massachusetts
Site Reference ID/Investigator# 100055	Recruiting
Burlington, Massachusetts, United States, 01805
Principal Investigator: Site Reference ID/Investigator# 100055
United States, New York
Site Reference ID/Investigator# 90533	Recruiting
New York, New York, United States, 10032
Principal Investigator: Site Reference ID/Investigator# 90533
United States, Texas
Site Reference ID/Investigator# 90537	Recruiting
Dallas, Texas, United States, 75203
Principal Investigator: Site Reference ID/Investigator# 90537
Spain
Site Reference ID/Investigator# 90573	Recruiting
Barcelona, Spain, 08028
Principal Investigator: Site Reference ID/Investigator# 90573

Sponsors and Collaborators

AbbVie

Investigators

Study Director:

Eoin Coakley, MD

AbbVie

More Information

No publications provided

Responsible Party:	AbbVie
ClinicalTrials.gov Identifier:	NCT01782495     History of Changes
Other Study ID Numbers:	M12-999, 2012-004792-39
Study First Received:	January 22, 2013
Last Updated:	June 27, 2013
Health Authority:	Spain: Agencia Española de Medicamentos y Productos Sanitarios United States: Food and Drug Administration

Keywords provided by AbbVie:

Chronic Hepatitis Hepatitis C Virus Hepatitis C Genotype 1 Interferon-Free Liver Transplant

Additional relevant MeSH terms:

Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Hepatitis, Viral, Human Liver Diseases Digestive System Diseases Virus Diseases Enterovirus Infections

Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Ribavirin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 02, 2013