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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01782495
Recruitment Status : Completed
First Posted : February 4, 2013
Results First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE January 22, 2013
First Posted Date  ICMJE February 4, 2013
Results First Submitted Date  ICMJE October 9, 2017
Results First Posted Date  ICMJE November 7, 2017
Last Update Posted Date November 7, 2017
Actual Study Start Date  ICMJE February 25, 2013
Actual Primary Completion Date November 2, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
Percentage of subjects with sustained virologic response 12 weeks post-treatment [ Time Frame: 12 weeks after the last actual dose of study drug ]
Hepatitis C virus ribonucleic acid less than the lower limit of quantification
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
  • Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24) [ Time Frame: 24 weeks after the last actual dose of study drug ]
    SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 24 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.
  • Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment) ]
    On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or confirmed HCV RNA ≥ LLOQ at any point during treatment after HCV RNA < LLOQ, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment.
  • Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug ]
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
  • Percentage of subjects with sustained virologic response 24 weeks post treatment [ Time Frame: 24 weeks after the last actual dose of study drug ]
    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 ]
    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 ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C Infection
Intervention  ICMJE
  • Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
    Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
    Other Names:
    • Viekira Pak
    • paritaprevir also known as ABT-450
    • ombitasvir also known as ABT-267
    • dasabuvir also known as ABT-333
  • Drug: ombitasvir/paritaprevir/ritonavir
    Tablet; ombitasvir coformulated with paritaprevir and ritonavir
    Other Names:
    • TECHNIVIE
    • paritaprevir also known as ABT-450
    • ombitasvir also known as ABT-267
  • Drug: ribavirin
    tablet
Study Arms  ICMJE
  • Experimental: Arm A
    Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
    Interventions:
    • Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
    • Drug: ribavirin
  • Experimental: Arm B
    Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
    Interventions:
    • Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
    • Drug: ribavirin
  • Experimental: Arm C
    Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
    Intervention: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
  • Experimental: Arm D
    Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
    Interventions:
    • Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
    • Drug: ribavirin
  • Experimental: Arm E
    Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
    Interventions:
    • Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
    • Drug: ribavirin
  • Experimental: Arm F
    Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
    Interventions:
    • Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
    • Drug: ribavirin
  • Experimental: Arm G
    Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
    Intervention: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
  • Experimental: Arm H
    Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
    Interventions:
    • Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
    • Drug: ribavirin
  • Experimental: Arm I
    Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
    Intervention: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
  • Experimental: Arm J
    Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
    Interventions:
    • Drug: ombitasvir/paritaprevir/ritonavir
    • Drug: ribavirin
  • Experimental: Arm K
    Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
    Interventions:
    • Drug: ombitasvir/paritaprevir/ritonavir
    • Drug: ribavirin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2017)
129
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2013)
30
Actual Study Completion Date  ICMJE July 13, 2017
Actual Primary Completion Date November 2, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   France,   Germany,   Puerto Rico,   Spain,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT01782495
Other Study ID Numbers  ICMJE M12-999
2012-004792-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc AbbVie
PRS Account AbbVie
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP