NCT00828269

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

January 21, 2009

Last Update Submit

April 21, 2015

Conditions

Chronic Hepatitis C

Keywords

Patients with Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

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

    5 weeks

Secondary Outcomes (1)

  • Comparison of qPCR and microarray signature from patients with no or minimal fibrosis to that from patients with moderate to advanced fibrosis.

    5 weeks

Study Arms (1)

1

NO INTERVENTION

Liver tissue biopsy

Procedure: Comparator: Fine needle aspiration biopsy

Interventions

Comparator: Fine needle aspiration biopsyPROCEDURE

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

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 23, 2009

Study Start

April 1, 2009

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

April 22, 2015

Record last verified: 2015-04