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

• Status: Terminated
• Trial end date: 2021-03-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taichung Veterans General Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Elbasvir-grazoprevir drug combination; Grazoprevir

Criteria

Inclusion Criteria:

1. At least 20 years of age

2. Chronically infected with genotypes 1b HCV

3. Underwent liver and/ or kidney transplantation

4. Without clinical or pathologic evidence of moderate or severe rejection

Exclusion Criteria:

1. HCV genotype other than 1b

2. Liver decompensation (Child-Pugh score > 6)

3. Co-infected with human immunodeficiency virus: Positive HIV1/2 or hepatitis B virus :

Positive HBsAg and detected HBV DNA

4. Prior exposure to an NS5A inhibitor

5. Any active malignancies

6. Hemoglobin level less than 10 g/dl

7. Platelet level of 75,000/mm3 or less

8. Alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase level 10 times or more the upper limit of normal

9. Total bilirubin level greater than 3 times or more the upper limit of normal

10. Albumin less than 3 g/dL

11. Using medication that is not considered safe to co-administer with , such as cyclosporine

12. Pregnant or breast-feeding women

13. Known allergy to grazoprevir or elbasvir

(Unregistered liver or kidney transplant in other countries is illegal in Taiwan)