Blood Draw Study for Liver Transplant Patients | NCT01525797

Studies
Blood Draw Study for Liver Transplant Patients

NCT01525797

Sponsor

Baylor Research Institute

Status

Completed

Last Update Posted

Jan 26, 2026Actual

Enrollment

221Actual

Phase

Not provided

Conditions

Liver Transplant Recipients

Interventions

Not provided

Countries

United States

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

Jan 2026

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

Oct 15, 2002Actual

Primary Completion Date

Oct 4, 2013Actual

Completion Date

Oct 4, 2013Actual

First Submitted Date

May 11, 2011

First Submission Date that Met QC Criteria

Feb 1, 2012

First Posted Date

Feb 3, 2012Estimated

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

Jan 23, 2026

Last Update Posted Date

Jan 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to see what a lab test will show and if there is a way to predict which patients will be more likely to have rejection after receiving a liver transplant.

Detailed Description

The purpose of this study is simply to see what the new oligonucleotide microarrays will show when comparing the the different patient groups. The results of this study will be one of the first steps In exploring the potential use of this new test.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

221Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify signatures predictive of graft rejection or tolerance.	Analyze the pattern of gene expression in patients undergoing solid organ transplantation	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Received a liver Transplant

Exclusion Criteria:

Received Multiple Organ Transplant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Liver Clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Goran Klintmalm, MD	Baylor Health Care System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baylor University Medical Center		Dallas	Texas	752245	United States

Label	Type	Description	Intervention Names
Control
Rejection