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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Procedure: Comparator: Fine needle aspiration biopsy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00828269

123

2009_518

0000-123

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

12 participants in 1 patient group

1

No Intervention group

Description:

Liver tissue biopsy

Treatment:

Procedure: Comparator: Fine needle aspiration biopsy