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)

NCT02692703 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M13-5962015-005616-14
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Hepatitis C; HCV; Hepatitis C Virus

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Percentage of Participants With On-treatment Virologic Failure

  Up to 12 weeks

• Percentage of Participants With Post-treatment Relapse

  From the end of treatment through 12 weeks after the last dose of study drug (up to 12 weeks)

Study Arms (1)

Glecaprevir/Pibrentasvir

EXPERIMENTAL

Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Drug: glecaprevir/pibrentasvir

Interventions

glecaprevir/pibrentasvir DRUG

Tablet; glecaprevir coformulated with pibrentasvir

Also known as: glecaprevir also known as ABT-493, pibrentasvir also known as ABT-530, MAVYRET

Glecaprevir/Pibrentasvir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Reau N, Kwo PY, Rhee S, Brown RS Jr, Agarwal K, Angus P, Gane E, Kao JH, Mantry PS, Mutimer D, Reddy KR, Tran TT, Hu YB, Gulati A, Krishnan P, Dumas EO, Porcalla A, Shulman NS, Liu W, Samanta S, Trinh R, Forns X. Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection. Hepatology. 2018 Oct;68(4):1298-1307. doi: 10.1002/hep.30046. Epub 2018 Jul 25.

  PMID: 29672891 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

glecaprevir and pibrentasvir; glecaprevir; pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Susan Rhee, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: April 22, 2016
• Primary Completion: April 13, 2017
• Study Completion: June 29, 2017
• Last Updated: July 13, 2021
• Results First Posted: April 4, 2018

Record last verified: 2021-07