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Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00828269
First received: January 21, 2009
Last updated: April 26, 2010
Last verified: April 2010
History of Changes
  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 1

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

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 ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00828269     History of Changes
Other Study ID Numbers: 2009_518, 123
Study First Received: January 21, 2009
Last Updated: April 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Merck:
Patients with Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on June 17, 2013