Trial record 1 of 1 for: SCARB1
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SR-BI and Antiviral Treatment Response in HCV
|ClinicalTrials.gov Identifier: NCT02714712|
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : July 14, 2017
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Information provided by (Responsible Party):
Ching-Sheng Hsu, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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.
|Condition or disease||Intervention/treatment|
|Chronic Hepatitis C||Drug: Peginterferon alfa-2a|
- 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|
|Actual Enrollment :||309 participants|
|Official Title:||Influence of Scavenger Receptor Class B Type I (SR-BI) Gene Polymorphisms on Antiviral Treatment Response, and Metabolism in Chronic Hepatitis C Patients|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||August 2016|
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.
Drug: Peginterferon alfa-2a
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 Name: Pegsys
There were 153 healthy controls negative for anti-HCV enrolled simultaneously from the database of Health Management Center.
Primary Outcome Measures :
- Serum HCV RNA levels [ Time Frame: at 24 weeks after the end of treatment ]sustained virologic response
Secondary Outcome Measures :
- serum fasting blood glucose levels [ Time Frame: at 24 weeks after the end of treatment ]
Biospecimen Retention: Samples With DNA
All enrolled subjects were genotyped for the SNPs of the SCARB1 gene and IL28B gene. All their blood specimens were collected into EDTA tubes. Human genomic DNA was extracted by standard protocols with blood RBC lysis, cell lysis, DNA binding, wash and elution. Extracted DNA normalized to 50 ng/µl was obtained. DNA quality was assessed by calculating the absorbance ratio OD260 nm/280 nm using NanoDrop model ND-1000 (Thermo Scientific, Wilmington, DE, USA). The SNP was genotyped by using the ABI TaqMan allelic discrimination kit and the ABI7900HT Sequence Detection System (Applied Biosystems, Foster City, CA, USA)
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