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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Comparator: Fine needle aspiration biopsy
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Hepatitis C focused on measuring Patients with Chronic Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    1

    Arm Description

    Liver tissue biopsy

    Outcomes

    Primary Outcome Measures

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

    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.

    Full Information

    First Posted
    January 21, 2009
    Last Updated
    April 21, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00828269
    Brief Title
    Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C (0000-123)
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    March 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C
    Keywords
    Patients with Chronic Hepatitis C

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    No Intervention
    Arm Description
    Liver tissue biopsy
    Intervention Type
    Procedure
    Intervention Name(s)
    Comparator: Fine needle aspiration biopsy
    Intervention Description
    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 Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

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

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