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

NCT ID: NCT00828269

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-03-31

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.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

1

Liver tissue biopsy

Group Type: NO_INTERVENTION

Comparator: Fine needle aspiration biopsy

Intervention Type: PROCEDURE

Visit 1: Screening Visit 2 (7-14 days from screening): Core needle biopsy and fine needle aspiration biopsy - liver.

Visit 3:(7 days from visit 2): Fine needle aspiration biopsy - liver. Visit 4: (14 days from Visit 3): follow-up visit

Interventions

Comparator: Fine needle aspiration biopsy

Visit 1: Screening Visit 2 (7-14 days from screening): Core needle biopsy and fine needle aspiration biopsy - liver.

Visit 3:(7 days from visit 2): Fine needle aspiration biopsy - liver. Visit 4: (14 days from Visit 3): follow-up visit

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

123

Identifier Type: -

Identifier Source: secondary_id

2009_518

Identifier Type: -

Identifier Source: secondary_id

0000-123

Identifier Type: -

Identifier Source: org_study_id