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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00828269
First Posted: January 23, 2009
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828269


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00828269     History of Changes
Other Study ID Numbers: 0000-123
123
2009_518
First Submitted: January 21, 2009
First Posted: January 23, 2009
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Patients with Chronic Hepatitis C

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