Evaluation of RNA From the Liver Tissue Obtained in Patie... | NCT00828269

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

NCT00828269

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Apr 22, 2015Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Chronic Hepatitis C

Interventions

Comparator: Fine needle aspiration biopsy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jan 21, 2009

First Submission Date that Met QC Criteria

Jan 21, 2009

First Posted Date

Jan 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2015

Last Update Posted Date

Apr 22, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	Liver tissue biopsy	Procedure: Comparator: Fine needle aspiration biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comparator: Fine needle aspiration biopsy	Procedure	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the probability that fine needle aspiration of the liver results in RNA suitable to conduct gene expression tests.		5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Comparison of qPCR and microarray signature from patients with no or minimal fibrosis to that from patients with moderate to advanced fibrosis.		5 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic

Ancestor Terms

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
123
2009_518