Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C (0000-123)

Phase 1

Completed

• Conditions: Chronic Hepatitis C

• Registration Number: NCT00828269
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to evaluate the quality of the RNA and the reproducibility of gene expression profiling from liver tissue samples obtained by fine needle aspiration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-23
• Study Start: 2009-04
• Primary Completion: 2010-02
• Study Completion: 2010-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patient has chronic hepatitis C (Genotype 1)
• Patient has the ability to avoid use of anticoagulants, nonsteroidal anti-inflammatory drugs and aspirin for at least 5 days before the liver biopsy

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Exclusion Criteria

• Patient has received any approved or investigational drugs for the treatment of hepatitis C in the six months before the liver biopsy
• Patient has HIV or Hepatitis B virus
• Patient has been diagnosed with liver cancer
• Patient has evidence of cirrhosis on any previous liver biopsy
• Patient has confirmed alcohol abuse in the last 12 months
• Patient has participated in any investigational drug study within 90 days before the current study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the probability that fine needle aspiration of the liver results in RNA suitable to conduct gene expression tests.	5 weeks

Secondary Outcome Measures

Name	Time	Method
Comparison of qPCR and microarray signature from patients with no or minimal fibrosis to that from patients with moderate to advanced fibrosis.	5 weeks