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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02692703
Other study ID # M13-596
Secondary ID 2015-005616-14
Status Completed
Phase Phase 3
First received
Last updated
Start date April 22, 2016
Est. completion date June 29, 2017

Study information

Verified date July 2021
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 29, 2017
Est. primary completion date April 13, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
glecaprevir/pibrentasvir
Tablet; glecaprevir coformulated with pibrentasvir

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 [ 12 weeks after the last dose of study drug (up to 24 weeks)
Secondary Percentage of Participants With On-treatment Virologic Failure 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
Secondary Percentage of Participants With Post-treatment Relapse 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)
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