SR-BI and Antiviral Treatment Response in HCV

Buddhist Tzu Chi Medical Foundation

Status: Completed

Conditions: Chronic Hepatitis C

Treatments: Drug: Peginterferon alfa-2a

Study type: Observational

Funder types: Other

Identifiers

NCT02714712

03-XD53-105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 309 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

309 participants in 2 patient groups

HCV group (Peginterferon alfa-2a)

Description:

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.

Treatment:

Drug: Peginterferon alfa-2a

Control Group

Description:

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