Histologic Changes and Noninvasive Assessment in Hepatitis C Patients Treated with Peginterferon Alpha-2a and Ribavirin
NCT ID: NCT01634919
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
55 participants
OBSERVATIONAL
2012-07-31
2018-02-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chronic hepatitis C
Chronic hepatitis C
chronic hepatitis C
acoustic radiation force impulse ultrasonography
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
chronic hepatitis C
acoustic radiation force impulse ultrasonography
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects with positive anti-HCV Ab in sera
* Subjects with detectable HCV RNA by quantitative real time polymerase chain reaction (PCR) (\> 50 IU/mL)
* Subjects without receiving any previous antiviral treatment
* Subjects undergoing radiologic studies (liver ultrasonography (USG), CT or MRI) to exclude the presence of hepatocellular carcinoma (HCC) within the last 1 year before enrolment
* All fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion
* Written informed consent should be obtained from all subjects.
Exclusion Criteria
* Positive test at screening for anti-hepatitis A virus (HAV) immunoglobulin M (IgM) Ab, HBsAg, anti-hepatitis D virus (HDV) Ab or anti- HIV Ab
* Histologically confirmed liver cirrhosis (F4 of fibrosis stage)
* If subjects have compromised liver function (Child-Pugh score \>6)
* Signs or symptoms of hepatocellular carcinoma within the last 1 year before enrolment
* History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia)
* Women with ongoing pregnancy or who are breast feeding
* Male partner of potentially pregnant women
* Neutrophil count \<1,500 cells/mm3 or platelet count \<75,000 cells/mm3 at screening
* Hemoglobin \<11 g/dL for females and \<12 g/dL for men at screening
* Serum creatinine level \>1.5 times the upper limit of normal at screening
* Evidence of immunosuppressive therapy
* History of severe psychiatric disease, especially depression.(Severe psychiatric disease is defined as major depression or psychosis, suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease)
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Boramae Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Won Kim
MD, PhD, Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Won Kim, Ph.D
Role: PRINCIPAL_INVESTIGATOR
SMG-SNU Boramae Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul Metropolitan Government Boramae Medical Center
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06-2012-74
Identifier Type: -
Identifier Source: org_study_id