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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01782495
First received: January 22, 2013
Last updated: August 24, 2016
Last verified: August 2016
  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 With ABT-333 and With or Without RBV in HCV Genotype 1 and ABT-450/r/ABT-267 With RBV in HCV GT4-Infected Adult Liver or Renal Transplant Recipients With 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: 195
Study Start Date: February 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: November 2016 (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: 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
Experimental: Arm J- GT4-infected non-cirrhotic post liver transplant
ABT-450/r/ABT-267 + RBV for 12 weeks
Drug: ABT-450/r/ABT-267
tablet
Drug: ribavirin (RBV)
tablet
Experimental: Arm K- GT4-infected with cirrhosis post liver transplant
ABT-450/r/ABT-267 + RBV for 24 weeks
Drug: ABT-450/r/ABT-267
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) with or without ABT-333 and with or without ribavirin in adult transplant recipients with hepatitis C virus (HCV) infection.
  Eligibility

Ages Eligible for Study:   18 Years to 115 Years   (Adult, Senior)
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 or 4 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

Locations
United States, Arizona
Site Reference ID/Investigator# 90539
Phoenix, Arizona, United States, 85054
United States, California
Site Reference ID/Investigator# 90538
San Francisco, California, United States, 94143
United States, Colorado
Site Reference ID/Investigator# 90535
Aurora, Colorado, United States, 80045
United States, Illinois
Site Reference ID/Investigator# 90562
Chicago, Illinois, United States, 60611
Site Reference ID/Investigator# 90563
Chicago, Illinois, United States, 60637
United States, Indiana
Site Reference ID/Investigator# 90536
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Site Reference ID/Investigator# 100055
Burlington, Massachusetts, United States, 01805
United States, Michigan
Site Reference ID/Investigator# 125419
Detroit, Michigan, United States, 48202
United States, New York
Site Reference ID/Investigator# 90533
New York, New York, United States, 10032
United States, Texas
Site Reference ID/Investigator# 90537
Dallas, Texas, United States, 75203
Site Reference ID/Investigator# 96250
Dallas, Texas, United States, 75246
Australia
Site Reference ID/Investigator# 123975
Camperdown, Australia, 2050
France
Site Reference ID/Investigator# 123435
Villejuif, France, 94804
Germany
Site Reference ID/Investigator# 123436
Hannover, Germany, 30625
Puerto Rico
Site Reference ID/Investigator# 147704
Hato Rey, Puerto Rico, 00918
Spain
Site Reference ID/Investigator# 90573
Barcelona, Spain, 08028
Site Reference ID/Investigator# 120947
Valencia, Spain, 46026
United Kingdom
Site Reference ID/Investigator# 123355
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Emily Dumas, PhD AbbVie
  More Information

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: August 24, 2016
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration

Keywords provided by AbbVie:
Hepatitis C Genotype 4
Chronic Hepatitis
Interferon-Free
Hepatitis C Virus
Renal Transplant
Liver Transplant
Hepatitis C Genotype 1

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

ClinicalTrials.gov processed this record on September 23, 2016