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)
![]() |
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: NCT02692703 |
Recruitment Status :
Completed
First Posted : February 26, 2016
Results First Posted : April 4, 2018
Last Update Posted : July 13, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis C HCV Hepatitis C Virus | Drug: glecaprevir/pibrentasvir | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | N/A |
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 |

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:
|
- 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.
- 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.
- 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.

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 and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Study Director: | Susan Rhee, MD | AbbVie |
Documents provided by AbbVie:
Publications:
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT02692703 |
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: | July 13, 2021 |
Last Verified: | July 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
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 |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections |