NCT03022006

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

January 15, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

January 12, 2017

Last Update Submit

April 11, 2017

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Sustained virologic response (SVR) rate at follow-up week 12.

    12 week

Study Arms (1)

Dialysis patients with genotype 1 HCV infection

OTHER

elbasvir/grazoprevir

Drug: elbasvir, grazoprevir

Interventions

elbasvir, grazoprevirDRUG
Dialysis patients with genotype 1 HCV infection

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hokkaido University

Sapporo, Hokkaido, 060-8638, Japan

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Goki Suda, Dr

    Norte Study Group

    PRINCIPAL INVESTIGATOR

  • Naoya Sakamoto, Prof

    Norte Study Group

    STUDY DIRECTOR

Central Study Contacts

Goki Suda, Dr.

CONTACT

011-716-1161gsudgast@pop.med.hokudai.ac.jp

Naoya Sakamoto, Prof

CONTACT

011-716-1161sakamoto@med.hokudai.ac.jp

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
assistant professor

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 16, 2017

Study Start

January 15, 2017

Primary Completion

March 1, 2019

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

JP(1)