SR-BI and Antiviral Treatment Response in HCV

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714712
• Other study ID #: 03-XD53-105
• Status: Completed
• Phase: N/A
• First received: March 9, 2016
• Last updated: July 12, 2017
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: July 2017
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum HCV RNA levels	sustained virologic response	at 24 weeks after the end of treatment
Secondary	serum fasting blood glucose levels		at 24 weeks after the end of treatment