- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02714712
SR-BI and Antiviral Treatment Response in HCV
July 12, 2017 updated by: Ching-Sheng Hsu, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Influence of Scavenger Receptor Class B Type I (SR-BI) Gene Polymorphisms on Antiviral Treatment Response, and Metabolism in Chronic Hepatitis C Patients
The scavenger receptor type B class I (SR-BI) is a receptor for high-density lipoproteins (HDL) and one of entry factors for hepatitis C virus (HCV).
The investigators aimed to examine the association of single nucleotide polymorphisms (SNPs) of the SCARB1 gene, which encodes SR-BI, with virologic responses to pegylated interferon-based treatment in Asian chronic hepatitis C (CHC) patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Purpose of study: To examine the impacts of single nucleotide polymorphisms (SNPs) relevant to SR-BI on CHC patients.
- Study Design To enroll 400 CHC patients during a 3-year period
- Specify objectives of study when collecting extra specimen from participants Collect blood samples for genomic DNA to examine the SR-BI gene polymorphisms.
- Expected Endpoints of Treatment Sustained virologic response (SVR) means undetectable serum HCV RNA levels 24 weeks after completion of antiviral therapy.
Study Type
Observational
Enrollment (Actual)
309
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
HCV genotype 1 or 2 patients who received pegylated interferon alfa-2a (Peg-IFN alfa-2a) plus ribavirin therapy were consecutively enrolled from the gastroenterological clinics
Description
Inclusion Criteria:
- Naive to IFN treatment and other experimental antiviral or immunosuppressive therapy before enrollment.
- Serum alanine aminotransferase levels, at least, twice the upper limit of normal on two occasions within the previous 6 months.
Exclusion Criteria:
- Positive for hepatitis B surface antigen
- Positive for human immunodeficiency virus antibody
- Had a known history or evidence of autoimmune liver disease, inheritable disorders, renal insufficiency, malignancy
- Had a history of daily alcohol consumption greater than 20 gram or active drug abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HCV group (Peginterferon alfa-2a)
A total of 156 chronic HCV genotype 1 or 2 patients who received Peginterferon alfa-2a (Peg-IFN alfa-2a) plus ribavirin therapy were consecutively enrolled from the gastroenterological clinics.
|
Peginterferon alfa-2a 180μg plus daily oral weight-based ribavirin (1,000 mg for body weight 75 kg or less, 1,200 mg for body weight greater than 75 kg) for 24 or 48 weeks
Other Names:
|
Control Group
There were 153 healthy controls negative for anti-HCV enrolled simultaneously from the database of Health Management Center.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum HCV RNA levels
Time Frame: at 24 weeks after the end of treatment
|
sustained virologic response
|
at 24 weeks after the end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum fasting blood glucose levels
Time Frame: at 24 weeks after the end of treatment
|
at 24 weeks after the end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
March 9, 2016
First Submitted That Met QC Criteria
March 16, 2016
First Posted (Estimate)
March 21, 2016
Study Record Updates
Last Update Posted (Actual)
July 14, 2017
Last Update Submitted That Met QC Criteria
July 12, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Peginterferon alfa-2a
Other Study ID Numbers
- 03-XD53-105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Share data when requested
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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