July 4, 2013

This study is currently recruiting participants.

Verified June 2013 by AbbVie
Sponsor:
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:


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 EspaƱola 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

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