NCT01623895

Brief Summary

To investigate effect of genetic variations on the toxicities and find optimal target population, the investigators planned to analyze the genetic polymorphisms of UDP-glucuronosyltransferase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2007

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 14, 2014

Status Verified

December 1, 2013

Enrollment Period

5.5 years

First QC Date

June 12, 2012

Last Update Submit

July 11, 2014

Conditions

Hemosiderosis

Outcome Measures

Primary Outcomes (1)

  • Genetic polymorphism associated with side effects of deferasirox

    Genetic polymorphism associated with side effects of deferasirox \- Side effects: Increased AST or ALT \> 5 x ULN or increased bilirubin \> 3 x ULN which was thought to be caused by deferasirox Serum creatinine level increase \> 50% above the baseline value. * Biospecimen Retention: Samples With DNA * Candidate genes exhibit polymorphisms and encodes proteins that are involved in the pharmacokinetics and pharmacodynamics of deferasirox. Candidate genes : MRP2, BCRP, UGT1A subfamily

    up to 1 year

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who received deferasirox because of transfusion associated iron overload

You may qualify if:

  • Patients who received deferasirox because of transfusion associated iron overload (Transfusion associated iron overload was defined as ferritin ≥ 1,000 ng/mL in patients who needed over 8 units of RBC transfusions per a year).
  • Patients with written informed consents

You may not qualify if:

  • Patients or parents refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Candidate genes exhibit polymorphisms and encodes proteins that are involved in the pharmacokinetics and pharmacodynamics of deferasirox. Candidate genes : MRP2, BCRP, UGT1A subfamily

MeSH Terms

Conditions

Hemosiderosis

Condition Hierarchy (Ancestors)

Iron OverloadIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Ph D., Professor

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 20, 2012

Study Start

December 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 14, 2014

Record last verified: 2013-12

Locations

KR(1)