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

NCT ID: NCT03022006

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-15

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.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dialysis patients with genotype 1 HCV infection

elbasvir/grazoprevir

Group Type: OTHER

elbasvir, grazoprevir

Intervention Type: DRUG

Interventions

elbasvir, grazoprevir

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Norte Study Group

OTHER

Sponsor Role: lead

Responsible Party

Goki Suda

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Goki Suda, Dr

Role: PRINCIPAL_INVESTIGATOR

Norte Study Group

Naoya Sakamoto, Prof

Role: STUDY_DIRECTOR

Norte Study Group

Locations

Hokkaido University

Sapporo, Hokkaido, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Goki Suda, Dr.

Role: CONTACT

gsudgast@pop.med.hokudai.ac.jp

011-716-1161

Naoya Sakamoto, Prof

Role: CONTACT

sakamoto@med.hokudai.ac.jp

011-716-1161

Facility Contacts

Goki Suda, Dr

Role: primary

Other Identifiers

016-0273

Identifier Type: -

Identifier Source: org_study_id