Chronic Liver Disease Clinical Trial
Official title:
Improvement of the Surveillance and Control of Liver Disease and Complication Due to Chronic Hepatitis C: Project A) Antiviral Drugs Use, Efficacy, Safety and Costs; Project B) Kinetics of Virological Response.
Hepatitis C virus (HCV) infection provokes thousands of deaths every year all over the
world, being the major cause of progressive liver disease, primary hepatic cancer and liver
transplantation. Today, a "curative" therapy is available, that can eradicate the viral
infection and determine the regression of liver fibrosis, also in cirrhotic subjects.
The current standard-of-care for HCV chronic infection is combination therapy with
peginterferon (P-IFN) and ribavirin (RBV). However, this treatment is not only expensive but
determines several side effects, that can reduce drug tolerance and hence, patient adherence
to therapy. There are two types of available P-IFN on the market: P-IFN alfa-2a (Pegasys®,
F.Hoffmann-La Roche) administered at a flat-dose of 180 mcg/week and P-IFN alfa-2b
(PegIntron®, Schering-Plough) given at a weight-based dose of 50 to 150 mcg/week. Since only
a single amino acid differentiates these types of IFN, administration strategies depend on
their pegilation with molecules of 40 or 12kDa, respectively, that accounts for differences
in the pharmacokinetic and pharmacodynamic drug-profile and influences probably also
bioactivity. No comparative data are available on the benefits and costs of the licensed
Peg-IFN plus RBV for the treatment of HCV infection in the real clinical practice, even if,
the benefit and favourable cost-efficacy of this antiviral therapy is well established and
of large consensus. Recently, the first randomized controlled mega-trial to compare
antiviral therapeutic efficacy in naïve patients with HCV-genotype 1 infection during
different regimens of P-IFN alfa-2b (at low and standard-dose) and P-IFN alfa-2a plus RBV,
has been published, confirming a similar efficacy, of around 40%, obtained with the three
schedules evaluated.
In Italy, a regional program on the Surveillance and Control of HCV Infection, set up by the
Regional Health Councillorship, has led to the development of a clinical and epidemiological
observatory, constituted by a network of liver tertiary centres (Hepatological Cooperative
Network of Veneto, HepCoVe). This collaborative group is connected on-line by a common
database that, since 2003, has prospectively collected data on a cohort of more than 3000
patients with chronic HCV infection and, among them, of 506 naïve subjects that
consecutively underwent combination therapy with P-IFN alfa-2a or alfa-2b plus RBV.
The aim of this study was to rationalize and improve the social regional health program on
antiviral treatment of chronic hepatitis C by assessing the different schedules utilization
of P-IFN plus RBV as well as the respective therapeutic effectiveness, safety and costs in
the real clinical practice (Project A).
(Project B) To evaluate the viral kinetic decay during antiviral combination therapy with P-IFN alfa-2a and 2b type plus ribavirin. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03704792 -
Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference
|
N/A | |
Terminated |
NCT02949375 -
Trial to Examine the Effect of Two Doses of GRI-0621 in Patients With Chronic Liver Disease
|
Phase 2 | |
Active, not recruiting |
NCT01205074 -
¹³C-Methacetin Breath Test (MBT) Methodology Study
|
Phase 2/Phase 3 | |
Completed |
NCT00756171 -
Colesevelam Versus Placebo in Cholestatic Pruritus
|
Phase 2/Phase 3 | |
Completed |
NCT05044663 -
Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in NASH Related Compensated Advanced Chronic Liver Disease.
|
||
Recruiting |
NCT04588077 -
Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis
|
Phase 4 | |
Recruiting |
NCT04802954 -
Risk Stratification of Hepatocarcinogenesis Using a Deep Learning Based Clinical, Biological and Ultrasound Model in High-risk Patients
|
N/A | |
Recruiting |
NCT04622449 -
Etiopathogenesis of Anemia in Chronic Liver Disease
|
||
Enrolling by invitation |
NCT05836246 -
The Development of Quantitative Ultrasound Imaging Software Platform
|
||
Completed |
NCT03087344 -
Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis
|
N/A | |
Completed |
NCT04751045 -
Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies Versus Percutaneous Liver Biopsies
|
N/A | |
Not yet recruiting |
NCT04526548 -
A Diagnostic Study on Patients With Drug-induced Liver Injury
|
||
Withdrawn |
NCT02899325 -
FDGal PET/CT to Detect Hepatocellular Carcinoma
|
||
Suspended |
NCT02650011 -
Clinical Features and Natural History of Acute-on-Chronic Liver Failure in Korean Patients With Chronic Liver Disease
|
||
Terminated |
NCT02530567 -
Non-invasive Evaluation of Portal Pressure by MRI
|
N/A | |
Completed |
NCT01851252 -
MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy
|
Phase 1 | |
Terminated |
NCT01756690 -
Predicting Lung Injury From Transfusion in Patients With Liver Disease
|
N/A | |
Completed |
NCT01600105 -
Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI)
|
Phase 4 | |
Completed |
NCT01008293 -
Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
|
Phase 2/Phase 3 | |
Completed |
NCT01634698 -
Relative-dose-response Test (RDR) Adaptation for Chronic Liver Disease
|
N/A |