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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03723824
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Teng-Yu Lee, Taichung Veterans General Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis c Liver Transplant Infection Kidney Transplant Infection Drug: grazoprevir 100 mg/ elbasvir 50 mg, Zepatier® Phase 4

Detailed Description:

Grazoprevir/elbasvir combination therapy (grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®, MSD) has been recommended as the 1st-line treatment for genotype 1b chronic hepatitis C by the updated international guidelines, and the rates of sustained virologic response (SVR) can be higher than 95% in either treatment-naïve or peginterferon-experienced patients with genotype 1b chronic hepatitis C. Moreover, even among patients with liver cirrhosis, the efficacy of grazoprevir/elbasvir combination therapy remains very high. In addition, drug-related adverse effects (AEs) were quite low in previous studies, and less than 1% of cirrhotic patients discontinued this therapy during treatment period (4). Grazoprevir/elbasvir combination therapy is an effective and safe treatment for chronic hepatitis C.

Chronic hepatitis C is one of the most common indications for liver transplantation. Patients underwent liver or kidney transplantation always suffer from recurrent chronic hepatitis C. Recurrent chronic hepatitis C can result in liver cirrhosis, liver decompensation, and death. Chronic hepatitis C is also associated with a higher incidence of chronic rejection, graft failure and mortality after kidney transplantation. Treating hepatitis C virus (HCV) infection after liver or kidney transplantation was a big challenge before the development of new direct-acting antiviral (DAA). Not only a low SVR rate but also a high rate of severe adverse effects results in the hesitation of peginterferon-ribavirin combination therapy. Although some new DAAs can be used in organ transplantation, the cost remains quite high. More new DAA choices for patients underwent organ transplantation are needed.

The clinical data of grazoprevir/elbasvir combination therapy on the treatment for patients with chronic hepatitis C after liver or kidney transplantation remain lacking. With high virologic response rates and low adverse effects in the management for chronic hepatitis C, grazoprevir/elbasvir combination therapy could be a good option for patients underwent liver or kidney transplantation. No drug-drug interaction (DDI) was noted between grazoprevir/elbasvir combination therapy and steroid, and the DDI with the most commonly-used immunosuppressant, tacrolimus, was also not significant, The drug levels of immunosuppressants can be carefully monitored and adjusted during treatment period. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®, 1# qd for 12 weeks
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Cohort Study of Grazoprevir/Elbasvir Combination Therapy for Patients With Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zepatier therapy
grazoprevir 100 mg/ elbasvir 50 mg (Zepatier®, MSD) once daily for 12 weeks
Drug: grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®
grazoprevir 100 mg/ elbasvir 50 mg (Zepatier®, MSD) once daily for 12 weeks
Other Name: Zepatier




Primary Outcome Measures :
  1. Sustained virologic response (SVR) [ Time Frame: At post-treatment week 12 ]
    The HCV viral load (IU/mL) in blood at post-treatment week 12 (SVR12)


Secondary Outcome Measures :
  1. Adverse effects (AEs) [ Time Frame: During the treatment period (the 1st, 2nd, 4th, 6th, 8th, 10th, 12th weeks) ]
    Any AEs during the treatment period

  2. Used immunosuppressant blood levels [ Time Frame: During the treatment period (the 1st, 2nd, 4th, 6th, 8th, 10th, 12th weeks) ]
    The immunosuppressant concentration (ng/mL) in blood during the treatment period



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

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): NCT03723824


Contacts
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Contact: Teng-Yu Lee, MD +886423592525 ext 3316 tylee@vghtc.gov.tw

Locations
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Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Teng-Yu Lee, MD    4-23592525 ext 3301    tylee@vghtc.gov.tw   
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
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Principal Investigator: Teng-Yu Lee, MD Taichung Veterans General Hospital

Publications of Results:
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Responsible Party: Teng-Yu Lee, Principle Investigator of the Liver Disease Center, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT03723824    
Other Study ID Numbers: SF18281A
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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MK-5172
Elbasvir-grazoprevir drug combination
Infection
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents