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A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)

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ClinicalTrials.gov Identifier: NCT02692703
Recruitment Status : Completed
First Posted : February 26, 2016
Results First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C virus (HCV) infection.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C HCV Hepatitis C Virus Drug: glecaprevir/pibrentasvir Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (MAGELLAN-2)
Actual Study Start Date : April 22, 2016
Actual Primary Completion Date : April 13, 2017
Actual Study Completion Date : June 29, 2017

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Glecaprevir/Pibrentasvir
Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
 Drug: glecaprevir/pibrentasvir
Tablet; glecaprevir coformulated with pibrentasvir
Other Names:
  • glecaprevir also known as ABT-493
  • pibrentasvir also known as ABT-530
  • MAVYRET


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last dose of study drug (up to 24 weeks) ]
    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. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 compared with the historical SVR12 rate for the current standard of care regimens (sofosbuvir [SOF]/ledipasvir [LDV] + ribavirin [RBV] OR SOF + daclatasvir [DCV] + RBV). Participants with missing data after backward imputation were counted as non-responders.


Secondary Outcome Measures :
  1. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 12 weeks ]
    On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

  2. Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug (up to 12 weeks) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, at least 18 years of age at time of screening.
  • Screening laboratory result indicating hepatitis C virus (HCV) genotype 1-6 (GT1-6) infection.
  • Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection at least 3 months prior to screening Or subject received a cadaveric or living donor kidney at least 3 months before screening.
  • Subjects must be documented as non-cirrhotic.
  • Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine, and/or cyclosporine.

Exclusion Criteria:

  • Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
  • Clinical history of fibrosing cholestatic hepatitis post-transplant.
  • Re-transplantation of the liver or kidney.
  • Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with high dose steroid within 3 months of screening.
  • History of post-transplant complications related to hepatic or renal vasculature.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692703


Sponsors and Collaborators
AbbVie
Investigators
Study Director: Susan Rhee, MD AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] June 21, 2016
Statistical Analysis Plan  [PDF] October 27, 2016

More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02692703     History of Changes
Other Study ID Numbers: M13-596
2015-005616-14 ( EudraCT Number )
First Posted: February 26, 2016    Key Record Dates
Results First Posted: April 4, 2018
Last Update Posted: April 4, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by AbbVie:
HCV Treatment Experienced
Hepatitis C
HCV Genotype 3
Without cirrhosis
Non-cirrhotic
HCV Genotype 2
Renal Transplant
HCV Treatment Naive
 Post transplant
HCV Genotype 6
Liver Transplant
HCV Genotype 5
HCV Genotype 4
Kidney Transplant
HCV Genotype 1

Additional relevant MeSH terms:
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