A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients (CORAL-I)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01782495
First received: January 22, 2013
Last updated: July 15, 2015
Last verified: July 2015
  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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, 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 With or Without Ribavirin (RBV) in Adult Transplant Recipients With Genotype 1 Hepatitis C Virus (HCV) Infection (CORAL-I)

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: 175
Study Start Date: February 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARM A- Post Liver transplant (>=12 months) fibrosis score <=F2
ABT-450/r/ABT-267 + ABT-333 + ribavirin (RBV) for 24 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: ribavirin (RBV)
tablet
Experimental: ARM B- Post Liver transplant (>=12 months) fibrosis score <=F3
ABT-450/r/ABT-267 + ABT-333 + ribavirin (RBV) for 24 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: ribavirin (RBV)
tablet
Experimental: ARM C- Post Liver transplant (>=12 months) fibrosis score <=F3
ABT-450/r/ABT-267 + ABT-333 for 24 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Experimental: ARM D- Liver transplant recipients with Child Pugh A cirrhosis
ABT-450/r/ABT-267 + ABT-333 + RBV for 24 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: ribavirin (RBV)
tablet
Experimental: ARM E- Liver transplant recipients with Child Pugh A cirrhosis
ABT-450/r/ABT-267 + ABT-333 + RBV for 12 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: ribavirin (RBV)
tablet
Experimental: ARM F- Post Liver transplant (>3 months) without cirrhosis
ABT-450/r/ABT-267 + ABT-333 + RBV for 12 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: ribavirin (RBV)
tablet
Experimental: ARM G- Post Liver transplant (>3 months) without cirrhosis
ABT-450/r/ABT-267 + ABT-333 for 12 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Experimental: ARM H- Renal transplant recipients
ABT-450/r/ABT-267 + ABT-333 + RBV for 12 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: ribavirin (RBV)
tablet
Experimental: ARM I- Renal transplant recipients
ABT-450/r/ABT-267 + ABT-333 for 12 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
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 with and without ribavirin in adult transplant recipients with hepatitis C virus (HCV) infection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, at least 18 years of age at the time of screening.
  2. 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.
  3. HCV IFN therapy treatment-naïve or -experienced, either pre or post liver or renal transplant.
  4. Screening HCV genotype testing indicating infection with genotype 1 HCV only.

Exclusion Criteria:

  1. Use of everolimus or sirolimus as part of the immunosuppressive regimen within 2 months of Screening Visit.
  2. Use of any medications listed below as well as those that are contraindicated for use with either ritonavir or RBV within 2 weeks prior to study drugs administration or 10 half-lives (if known), whichever is longer.
  3. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
  4. 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.
  5. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Christopher Negro, MS 847-935-9357 christopher.negro@abbvie.com
Contact: Jim Watson, MS 847.938.7414 jim.watson@abbvie.com

Locations
United States, Arizona
Site Reference ID/Investigator# 90539 Active, not recruiting
Phoenix, Arizona, United States, 85054
United States, California
Site Reference ID/Investigator# 90538 Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Site Reference ID/Investigator# 90538         
United States, Colorado
Site Reference ID/Investigator# 90535 Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
Site Reference ID/Investigator# 90562 Active, not recruiting
Chicago, Illinois, United States, 60611
Site Reference ID/Investigator# 90563 Active, not recruiting
Chicago, Illinois, United States, 60637
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 Active, not recruiting
Burlington, Massachusetts, United States, 01805
United States, Michigan
Site Reference ID/Investigator# 125419 Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Site Reference ID/Investigator# 125419         
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         
Site Reference ID/Investigator# 96250 Recruiting
Dallas, Texas, United States, 75246
Principal Investigator: Site Reference ID/Investigator# 96250         
Australia
Site Reference ID/Investigator# 123975 Recruiting
Camperdown, Australia, 2050
Principal Investigator: Site Reference ID/Investigator# 123975         
France
Site Reference ID/Investigator# 123435 Recruiting
Villejuif, France, 94804
Principal Investigator: Site Reference ID/Investigator# 123435         
Germany
Site Reference ID/Investigator# 123436 Recruiting
Hannover, Germany, 30625
Principal Investigator: Site Reference ID/Investigator# 123436         
Spain
Site Reference ID/Investigator# 90573 Active, not recruiting
Barcelona, Spain, 08028
Site Reference ID/Investigator# 120947 Recruiting
Valencia, Spain, 46026
Principal Investigator: Site Reference ID/Investigator# 120947         
United Kingdom
Site Reference ID/Investigator# 123355 Recruiting
London, United Kingdom, SE5 9RS
Principal Investigator: Site Reference ID/Investigator# 123355         
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Eoin Coakley, MD AbbVie
  More Information

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: July 15, 2015
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
Renal Transplant

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Infection
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2015