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SR-BI and Antiviral Treatment Response in HCV

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ClinicalTrials.gov Identifier: NCT02714712
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Ching-Sheng Hsu, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Brief Summary:
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

Detailed Description:
  1. Purpose of study: To examine the impacts of single nucleotide polymorphisms (SNPs) relevant to SR-BI on CHC patients.
  2. Study Design To enroll 400 CHC patients during a 3-year period
  3. Specify objectives of study when collecting extra specimen from participants Collect blood samples for genomic DNA to examine the SR-BI gene polymorphisms.
  4. Expected Endpoints of Treatment Sustained virologic response (SVR) means undetectable serum HCV RNA levels 24 weeks after completion of antiviral therapy.

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Study Type : Observational
Actual Enrollment : 309 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


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.
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

Control Group
There were 153 healthy controls negative for anti-HCV enrolled simultaneously from the database of Health Management Center.



Primary Outcome Measures :
  1. Serum HCV RNA levels [ Time Frame: at 24 weeks after the end of treatment ]
    sustained virologic response


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  1. Naive to IFN treatment and other experimental antiviral or immunosuppressive therapy before enrollment.
  2. Serum alanine aminotransferase levels, at least, twice the upper limit of normal on two occasions within the previous 6 months.

Exclusion Criteria:

  1. Positive for hepatitis B surface antigen
  2. Positive for human immunodeficiency virus antibody
  3. Had a known history or evidence of autoimmune liver disease, inheritable disorders, renal insufficiency, malignancy
  4. Had a history of daily alcohol consumption greater than 20 gram or active drug abuse.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ching-Sheng Hsu, Attending physician, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT02714712     History of Changes
Other Study ID Numbers: 03-XD53-105
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share data when requested
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Peginterferon alfa-2a
Interferon-alpha
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs