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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03022006
Enrollment
60
Registered
2017-01-16
Start date
2017-01-15
Completion date
Unknown
Last updated
2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

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.

Interventions

DRUGelbasvir, grazoprevir

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Norte Study Group
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Sustained virologic response (SVR) rate at follow-up week 12.12 week

Countries

Japan

Contacts

Primary ContactGoki Suda, Dr.
gsudgast@pop.med.hokudai.ac.jp011-716-1161
Backup ContactNaoya Sakamoto, Prof
sakamoto@med.hokudai.ac.jp011-716-1161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026