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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: Fine needle aspiration biopsy

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

Primary outcomes

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

Time frame: 5 weeks

Secondary outcomes

Comparison of qPCR and microarray signature from patients with no or minimal fibrosis to that from patients with moderate to advanced fibrosis.

Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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.

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jan 23, 2009
Registry last updated: Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed