Clinical trial NCT01782495: A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C Genotype 4
Chronic Hepatitis
Interferon-Free
Hepatitis C Virus (HCV)
Renal Transplant
Liver Transplant
Hepatitis C Genotype 1
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
timeFrame: 24 weeks after the last actual dose of study drug
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment)
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: From the end of treatment through 12 weeks after the last dose of study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_DIRECTOR
References:
citation: 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.