SR-BI and Antiviral Treatment Response in HCV

NCT02714712 | Completed

• 1 other identifier: 03-XD53-105
• Study Type: observational
• Target: 309
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Serum HCV RNA levels

  sustained virologic response

  at 24 weeks after the end of treatment

Secondary Outcomes (1)

• serum fasting blood glucose levels

  at 24 weeks after the end of treatment

Study Arms (2)

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

Control Group

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

Interventions

Peginterferon alfa-2a DRUG

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

Also known as: Pegsys

HCV group (Peginterferon alfa-2a)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Related Publications (1)

• Hsu CS, Hsu SJ, Liu WL, Chen DS, Kao JH. Association of SCARB1 Gene Polymorphisms with Virological Response in Chronic Hepatitis C Patients Receiving Pegylated Interferon plus Ribavirin Therapy. Sci Rep. 2016 Aug 26;6:32303. doi: 10.1038/srep32303.

  PMID: 27561198 DERIVED

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)

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 21, 2016
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 14, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share