SR-BI and Antiviral Treatment Response in HCV

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Peginterferon alfa-2a

• Registration Number: NCT02714712
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-21
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCV group (Peginterferon alfa-2a)	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.

Primary Outcome Measures

Name	Time	Method
Serum HCV RNA levels	at 24 weeks after the end of treatment	sustained virologic response

Secondary Outcome Measures

Name	Time	Method
serum fasting blood glucose levels	at 24 weeks after the end of treatment