Grazoprevir/Elbasvir for Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation

NCT03723824 | Terminated Phase 4

• 1 other identifier: SF18281A
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

Grazoprevir/elbasvir combination therapy is highly effective in the treatment of genotype 1b chronic hepatitis C, and the drug-drug interaction with central immunosuppressant, such as tacrolimus, should be manageable. The aim of this study is to assess the efficacy and tolerability of grazoprevir/elbasvir combination therapy in treating genotype 1b chronic hepatitis C after liver or kidney transplantation.

Conditions

Chronic Hepatitis c; Liver Transplant Infection; Kidney Transplant Infection

Outcome Measures

Primary Outcomes (1)

• Sustained virologic response (SVR)

  The HCV viral load (IU/mL) in blood at post-treatment week 12 (SVR12)

  At post-treatment week 12

Secondary Outcomes (2)

• Adverse effects (AEs)

  During the treatment period (the 1st, 2nd, 4th, 6th, 8th, 10th, 12th weeks)

• Used immunosuppressant blood levels

  During the treatment period (the 1st, 2nd, 4th, 6th, 8th, 10th, 12th weeks)

Study Arms (1)

Zepatier therapy

EXPERIMENTAL

grazoprevir 100 mg/ elbasvir 50 mg (Zepatier®, MSD) once daily for 12 weeks

Drug: grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®

Interventions

grazoprevir 100 mg/ elbasvir 50 mg, Zepatier® DRUG

grazoprevir 100 mg/ elbasvir 50 mg (Zepatier®, MSD) once daily for 12 weeks

Also known as: Zepatier

Zepatier therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 20 years of age
• Chronically infected with genotypes 1b HCV
• Underwent liver and/ or kidney transplantation
• Without clinical or pathologic evidence of moderate or severe rejection

You may not qualify if:

• HCV genotype other than 1b
• Liver decompensation (Child-Pugh score \> 6)
• Co-infected with human immunodeficiency virus: Positive HIV1/2 or hepatitis B virus : Positive HBsAg and detected HBV DNA
• Prior exposure to an NS5A inhibitor
• Any active malignancies
• Hemoglobin level less than 10 g/dl
• Platelet level of 75,000/mm3 or less
• Alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase level 10 times or more the upper limit of normal
• Total bilirubin level greater than 3 times or more the upper limit of normal
• Albumin less than 3 g/dL
• Using medication that is not considered safe to co-administer with , such as cyclosporine
• Pregnant or breast-feeding women
• Known allergy to grazoprevir or elbasvir
• (Unregistered liver or kidney transplant in other countries is illegal in Taiwan)

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Related Publications (4)

• Zeuzem S, Ghalib R, Reddy KR, Pockros PJ, Ben Ari Z, Zhao Y, Brown DD, Wan S, DiNubile MJ, Nguyen BY, Robertson MN, Wahl J, Barr E, Butterton JR. Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Ann Intern Med. 2015 Jul 7;163(1):1-13. doi: 10.7326/M15-0785.

  PMID: 25909356 RESULT

• Kwo P, Gane EJ, Peng CY, Pearlman B, Vierling JM, Serfaty L, Buti M, Shafran S, Stryszak P, Lin L, Gress J, Black S, Dutko FJ, Robertson M, Wahl J, Lupinacci L, Barr E, Haber B. Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients With Chronic Hepatitis C Infection. Gastroenterology. 2017 Jan;152(1):164-175.e4. doi: 10.1053/j.gastro.2016.09.045. Epub 2016 Oct 5.

  PMID: 27720838 RESULT

• Jacobson IM, Lawitz E, Kwo PY, Hezode C, Peng CY, Howe AYM, Hwang P, Wahl J, Robertson M, Barr E, Haber BA. Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis. Gastroenterology. 2017 May;152(6):1372-1382.e2. doi: 10.1053/j.gastro.2017.01.050. Epub 2017 Feb 11.

  PMID: 28193518 RESULT

• Lai PC, Chen CH, Jeng LB, Yu TM, Tsai SF, Wu MJ, Cheng SB, Yang SS, Lee TY. Grazoprevir/Elbasvir Treatment in Liver or Kidney Transplant Recipients with Genotype 1b Hepatitis C Virus Infection. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0200321. doi: 10.1128/AAC.02003-21. Epub 2021 Dec 13.

  PMID: 34902265 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

grazoprevir; elbasvir; elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Hepatitis C; 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

Study Officials

• Teng-Yu Lee, MD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator of the Liver Disease Center

Model Details: grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®, 1# qd for 12 weeks

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: February 14, 2019
• Primary Completion: November 30, 2020
• Study Completion: March 13, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)