- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02692703
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)
July 9, 2021 updated by: AbbVie
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glecaprevir/Pibrentasvir
Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
|
Tablet; glecaprevir coformulated with pibrentasvir
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks after the last dose of study drug (up to 24 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 12 weeks
|
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.
|
From the end of treatment through 12 weeks after the last dose of study drug (up to 12 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Susan Rhee, MD, AbbVie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 22, 2016
Primary Completion (Actual)
April 13, 2017
Study Completion (Actual)
June 29, 2017
Study Registration Dates
First Submitted
February 23, 2016
First Submitted That Met QC Criteria
February 23, 2016
First Posted (Estimate)
February 26, 2016
Study Record Updates
Last Update Posted (Actual)
July 13, 2021
Last Update Submitted That Met QC Criteria
July 9, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
Other Study ID Numbers
- M13-596
- 2015-005616-14 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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