Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00828269

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis C	Procedure: Comparator: Fine needle aspiration biopsy	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind (Subject), Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To evaluate the probability that fine needle aspiration of the liver results in RNA suitable to conduct gene expression tests. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	April 2009
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Liver tissue biopsy	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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828269

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, New York
Call for Information	Recruiting
New York, New York, United States, 10065

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_518, 123
Study First Received:	January 21, 2009
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00828269 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Merck:

Patients with Chronic Hepatitis C

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases

Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on September 10, 2009