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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

January 21, 2009
April 26, 2010
April 2009
February 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00828269 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C
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.

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Chronic Hepatitis C
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
No Intervention: 1
Liver tissue biopsy
Intervention: Procedure: Comparator: Fine needle aspiration biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00828269
2009_518, 123
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP