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.|
|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Dialysis patients with genotype 1 HCV infection
Drug: elbasvir, grazoprevir
- Sustained virologic response (SVR) rate at follow-up week 12. [ Time Frame: 12 week ]
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): NCT03022006
|Contact: Goki Suda, Dr.||firstname.lastname@example.org|
|Contact: Naoya Sakamoto, Profemail@example.com|
|Sapporo, Hokkaido, Japan, 060-8638|
|Contact: Goki Suda, Dr|
|Principal Investigator:||Goki Suda, Dr||Norte Study Group|
|Study Director:||Naoya Sakamoto, Prof||Norte Study Group|