Chronic Hepatitis C Clinical Trial
Official title:
Safety and Effect of Elbasvir/Grazoprevir Combination Therapy in Hemodialysis Patients With Chronic Hepatitis C
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01937975 -
The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)
|
Phase 1 | |
| Completed |
NCT03673696 -
The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT02250001 -
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
|
N/A | |
| Completed |
NCT03088917 -
'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'
|
||
| Completed |
NCT02207088 -
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
|
Phase 3 | |
| Not yet recruiting |
NCT02865369 -
Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment
|
N/A | |
| Recruiting |
NCT02638233 -
Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy
|
Phase 4 | |
| Not yet recruiting |
NCT02511496 -
Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia
|
N/A | |
| Completed |
NCT02788682 -
Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy
|
N/A | |
| Not yet recruiting |
NCT01949168 -
A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV
|
Phase 2 | |
| Completed |
NCT01439776 -
Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients
|
Phase 4 | |
| Recruiting |
NCT01360892 -
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography
|
N/A | |
| Recruiting |
NCT01360879 -
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
|
N/A | |
| Completed |
NCT00968357 -
Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed
|
Phase 2 | |
| Terminated |
NCT00962936 -
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
|
Phase 1/Phase 2 | |
| Recruiting |
NCT00575627 -
Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels
|
Phase 4 | |
| Recruiting |
NCT01178749 -
Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments
|
N/A | |
| Completed |
NCT00537407 -
A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment
|
Phase 2 | |
| Recruiting |
NCT00370617 -
Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance
|
Phase 4 | |
| Completed |
NCT01684787 -
Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients
|
Phase 4 |