Chronic Hepatitis CNCT01634919
Histologic Changes and Noninvasive Assessment in Hepatitis C Patients Treated with Peginterferon Alpha-2a and Ribavirin
An observational study of Chronic Hepatitis C, run by Seoul National University Boramae Hospital at 2 sites in South Korea.
Trial summary
•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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- chronic hepatitis C
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jul 2012to 9 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital-based cohort
Who may be able to join
- Male and female subjects ≥20 years of age
- 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.
Who cannot join
- History of any interferon (IFN)-based therapy before enrolment
- 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)
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- 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)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul Metropolitan Government Boramae Medical Center
Seoul, 156-707
SMG-SNU Boramae Medical Center
Seoul, 156-707
About this study
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
Read the detailed description
- 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.
- Conditions
- Chronic Hepatitis C
- Being tested
- chronic hepatitis C
- Keywords
- Chronic hepatitis C, Liver fibrosis, ARFI(Acoustic radiation force impulse)
- Medical subject headings
- Hepatitis C, Chronic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chronic hepatitis CDevice
Also called noninvasive fibrosis imaging
acoustic radiation force impulse ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Chronic hepatitis C | Chronic hepatitis C Receives: Device: chronic hepatitis C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-fibrotic response
Anti-fibrotic response, indicated by a lack of histological worsening, defined as the stabilization or the improvement of at least one stage in the histologic fibrosis staging 48 weeks after the end of treatment
Measured: 48 weeks after the end of treatment
Secondary outcomes (1)
Histologic and noninvasive fibrosis assessments
- Liver fibrosis score(according to the viral genotype or virologic response)
- Morphometric analysis of fibrosis surface area
- Acoustic radiation force impulse (ARFI) ultrasound imaging and clinical fibrosis indices (APRI, FIB-4, FibroTest®, and ELF test)
- Noninvasive tests using the tissue shear wave speed and clinical fibrosis indices
Measured: 48 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJul 2012
- Primary completion17 Feb 2017
- Study completion9 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Boramae Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Kim, Seoul National University Boramae Hospital
- Investigators
- Won Kim, Ph.D, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634919
- Sponsor's protocol ID
- 06-2012-74
- Status last verified
- Nov 2024
- First submitted
- 3 Jul 2012
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01634919
- Acronym / sponsor ID
- 06-2012-74
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Liver fibrosis, ARFI(Acoustic radiation force impulse)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Seoul National University Boramae HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 17 Feb 2017 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
•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
Detailed description
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic hepatitis C | – | Device: chronic hepatitis CChronic hepatitis C |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital-based cohort
Key inclusion criteria (7 listed)
- Male and female subjects ≥20 years of age
- 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
Key exclusion criteria (13 listed)
- History of any interferon (IFN)-based therapy before enrolment
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chronic hepatitis CAlso: noninvasive fibrosis imagingacoustic radiation force impulse ultrasonography | Device | Chronic hepatitis C |
Primary outcome
Anti-fibrotic response
Time frame: 48 weeks after the end of treatment
Anti-fibrotic response, indicated by a lack of histological worsening, defined as the stabilization or the improvement of at least one stage in the histologic fibrosis staging 48 weeks after the end of treatment
1 secondary outcome
Histologic and noninvasive fibrosis assessments
Time frame: 48 weeks after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Kim, Ph.D principal investigator
SMG-SNU Boramae Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by Seoul National University Boramae Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-fibrotic response (time frame: 48 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.