CompletedPhase 3

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)

100 participantsStarted 2016-04-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

Timeframe: 12 weeks after the last dose of study drug (up to 24 weeks)

Trial details

NCT IDNCT02692703

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-04-13

Results submitted2018-03-08

View on ClinicalTrials.gov More Chronic Hepatitis C trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.