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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02692703
First Posted: February 26, 2016
Last Update Posted: July 12, 2017
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.
Information provided by (Responsible Party):
AbbVie
  Purpose
The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 in adults who are post primary orthotopic liver or renal transplant with chronic Hepatitis C Virus infection.

Condition Intervention Phase
Chronic Hepatitis C HCV Hepatitis C Virus Drug: ABT-493/ABT-530 Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of Participants with Sustained Virologic Response 12 weeks After Treatment compared to the historical Sustained Virologic Response 12 weeks. [ Time Frame: 12 weeks after the last dose of study drug ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification 12 weeks after the last dose of study drug.


Secondary Outcome Measures:
  • The percentage of participants with on-treatment virologic failure [ Time Frame: Up to Week 12 ]
    The percentage of participants with confirmed increase of > 1 log10 IU/mL in HCV RNA above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment)

  • The percentage of participants with post-treatment relapse [ Time Frame: Up to 12 weeks after the last dose of study drug ]
    Percentage of participants with confirmed quantifiable HCV RNA between end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with unquantifiable HCV RNA at the end of treatment.


Enrollment: 100
Study Start Date: April 22, 2016
Study Completion Date: June 29, 2017
Primary Completion Date: April 13, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-493/ABT-530
ABT-493/ABT-530 for 12 weeks
Drug: ABT-493/ABT-530
Tablet

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (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 HCV 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
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


  Show 27 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Susan Rhee, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02692703     History of Changes
Other Study ID Numbers: M13-596
2015-005616-14 ( EudraCT Number )
First Submitted: February 23, 2016
First Posted: February 26, 2016
Last Update Posted: July 12, 2017
Last Verified: July 2017

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