Evaluation of Phlebotomy as a Treatment for Non-alcoholic... | NCT00641524

Studies
Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease

NCT00641524

Sponsor

University of Western Ontario, Canada

Status

Completed

Last Update Posted

May 13, 2016Estimated

Enrollment

45Actual

Phase

Not Applicable

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Phlebotomy

Countries

Canada

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

May 2016

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

Jan 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 17, 2008

First Submission Date that Met QC Criteria

Mar 17, 2008

First Posted Date

Mar 24, 2008Estimated

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

May 12, 2016

Last Update Posted Date

May 13, 2016Estimated

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 evaluate the use of phlebotomy (blood taking)as a treatment for patients with non-alcoholic fatty liver disease.

Detailed Description

In this study phlebotomy will be evaluated as a therapy for non-alcoholic fatty liver disease (NAFLD), a common and important cause of liver disease. Phlebotomy has been used for many years in the treatment of disorders of iron overload such as hemochromatosis, where it is well tolerated and improves symptoms and survival. There is some evidence that it is also effective in treating NAFLD. However, previous studies have not evaluated whether phlebotomy improves liver biopsy findings. We will measure the severity disease in NAFLD patients prior to phlebotomy therapy and again at the end of treatment. This will allow us to accurately determine the benefit of this therapy in these patients.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment	Other	Iron depletion via phlebotomy	Procedure: Phlebotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phlebotomy	Procedure	Phlebotomy involves the removal of blood (approximately 500mL) each week until body iron levels reach the low-normal level	treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severity of liver disease		6 months after final treatment

Secondary Outcomes

Measure	Description	Time Frame
Severity of metabolic disease		6 months after final treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18y or older
Diagnosis of Non-alcoholic Fatty Liver Disease

Exclusion Criteria:

Unable or unwilling to provide informed consent
Alcohol consumption of >10g/day for women and >20g/day for men

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Melanie D Beaton, MD	Western University, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Centre		London	Ontario	N6A 5A5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23441892	Derived	Beaton MD, Chakrabarti S, Levstik M, Speechley M, Marotta P, Adams P. Phase II clinical trial of phlebotomy for non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2013 Apr;37(7):720-9. doi: 10.1111/apt.12255. Epub 2013 Feb 26.

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D008103	Liver Cirrhosis
D024821	Metabolic Syndrome
D019190	Iron Overload

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis

ID	Term
D001800	Blood Specimen Collection
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures