Chronic Hepatitis C Clinical Trial
Official title:
A Single Center, Prospective Study Evaluating the Anti-fibrotic Effect of Combination Therapy of Peginterferon Alpha-2a Plus Ribavirin in Patients With Chronic Hepatitis C, Based on Histologic Changes and Noninvasive Fibrosis Assessments
•The purpose of this study is to compare the performance between liver biopsy and non-invasive fibrosis assessments evaluating anti-fibrotic efficacy of peginterferon plus ribavirin in patients with hepatitis C pre- and post-treatment
- Patients with histologically advanced hepatitis C receiving peginterferon plus ribavirin
combination therapy have showed 30-40% of a sustained virologic response (SVR) rate and
50% of histologic improvement.
- The histologic change of liver is the most important prognosticator to predict further
clinical outcomes in advanced hepatitis C patients following peginterferon-based
antiviral therapy.
- Although liver biopsy remains the gold standard for histologic assessment, it has
several shortcomings in terms of poor repeatability due to its invasiveness and poor
reproducibility due to sampling error and intra- or inter-observer variability.
- Treatment-naïve patients with chronic hepatitis C will receive PEGASYS® 180 mcg once
weekly and ribavirin twice daily for 24 or 48 weeks depending on the genotype of
hepatitis C virus (HCV).
- All subjects will be followed for up to 48 weeks after treatment cessation.
- Liver biopsy will be done at baseline and the end of follow-up for the evaluation of
histologic response.
- Noninvasive tests for liver fibrosis (ARFI elastography, APRI, FIB-4, FibroTest®, and
ELF test) will be assessed per 24 weeks during the whole study period.
- The results of this study will provide insight into the histo-physical link between
histologic changes and liver stiffness dynamics during and after peginterferon alpha-2a
plus ribavirin treatment in patients with advanced hepatitis C.
- Therefore, noninvasive fibrosis assessments may be useful to trace fibrosis outcomes in
patients with advanced hepatitis C receiving antiviral therapy.
;
| 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 |