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

Chronic Hepatitis C Clinical Trial

Official title:

Evaluation of RNA Quality and the Reproducibility of Gene Expression Profiling From Liver Tissue Obtained by Fine Needle Aspiration in Patients With Chronic Hepatitis C.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828269
• Other study ID #: 0000-123
• Secondary ID: 1232009_518
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2009
• Last updated: April 21, 2015
• Start date: April 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the probability that fine needle aspiration of the liver results in RNA suitable to conduct gene expression tests.		5 weeks	No
Secondary	Comparison of qPCR and microarray signature from patients with no or minimal fibrosis to that from patients with moderate to advanced fibrosis.		5 weeks	No