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Safety and Effect of Elbasvir/Grazoprevir Combination Therapy in Hemodialysis Patients With Chronic Hepatitis C

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. Read our disclaimer for details. Identifier: NCT03022006
Recruitment Status : Unknown
Verified April 2017 by Goki Suda, Norte Study Group.
Recruitment status was:  Recruiting
First Posted : January 16, 2017
Last Update Posted : April 12, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Goki Suda, Norte Study Group

Brief Summary:

The number of hemodialysis patients with chronic renal failure in Japan exceeds 0.3 million and is showing an increasing trend. The rate of infection with hepatitis C virus (HCV) is high in hemodialysis patients, and it has been revealed that the prognosis is poorer in HCV-infected hemodialysis patients compared to uninfected patients; therefore, aggressive therapeutic intervention is required.Investigator previously reported the efficacy and safety of a NS5A inhibitor; daclatasvir and a HCV protease inhibitor; asunaprevir combination therapy for Japanese dialysis patients with genotype 1 HCV infection. However, the duration of the treatment is 24 week, which is quite longer than current standard 12 week therapy .

elbasvir/grazoprevir combination therapy is oral anti-HCV 12 week therapy without the use of IFN/ribavirin, and a good therapeutic effect has been reported in Japanese phase II studies . Of note is that these drugs are metabolized mainly in the liver and thus they can be used in patients with chronic renal failure. Recently, David Roth et al reported that the efficacy and safety of elbasvir/grazoprevir combination therapy for patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease. In this report, they revealed that elbasvir/grazoprevir combination therapy could achieve SVR rate of 99% in the modified full analysis set.

However, no adequate clinical investigation has been performed in Japan, thus far concerning the therapeutic effect and safety of elbasvir/grazoprevir combination therapy in Japanese hemodialysis patients.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: elbasvir, grazoprevir Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effect of Elbasvir/Grazoprevir Combination Therapy in Hemodialysis Patients With Chronic Hepatitis C
Actual Study Start Date : January 15, 2017
Estimated Primary Completion Date : March 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Dialysis patients with genotype 1 HCV infection
Drug: elbasvir, grazoprevir

Primary Outcome Measures :
  1. Sustained virologic response (SVR) rate at follow-up week 12. [ Time Frame: 12 week ]

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

Inclusion criteria

  • Patients aged 20 years or older at the time of consent
  • Patients who received an adequate explanation prior to the study and provided written consent for participation in the study
  • Hemodialysis patients complicated by chronic hepatitis C who have HCV Genotype 1b infection and do not meet the exclusion criteria listed in the following section

Exclusion criteria

  • Patients with a past history of hypersensitivity to HCV protease inhibitors and NS5A inhibitors
  • Patients with serious liver dysfunction (Child-Pugh Class B or C)
  • Patients with difficult-to-control heart disease (e.g., myocardial infarction, heart failure, and arrhythmia)
  • Patients who have malignant tumors, including hepatoma, at the start of treatment
  • Patients on treatment with drugs listed in the contraindications for coadministration in the package insert (e.g., some antifungals, some antiepileptics, and human immunodeficiency virus (HIV) protease inhibitors)
  • Patients with albumin <3.0 g/dL and platelets <75,000 /μL
  • Other patients judged to be inappropriate to participate in the study by the primary physician
  • Other patients judged to be inappropriate as study subjects by the study manager

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 identifier (NCT number): NCT03022006

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Contact: Goki Suda, Dr. 011-716-1161
Contact: Naoya Sakamoto, Prof 011-716-1161

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Hokkaido University Recruiting
Sapporo, Hokkaido, Japan, 060-8638
Contact: Goki Suda, Dr         
Sponsors and Collaborators
Norte Study Group
Merck Sharp & Dohme Corp.
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Principal Investigator: Goki Suda, Dr Norte Study Group
Study Director: Naoya Sakamoto, Prof Norte Study Group

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Responsible Party: Goki Suda, assistant professor, Norte Study Group Identifier: NCT03022006     History of Changes
Other Study ID Numbers: 016-0273
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
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