NCT00327639

Brief Summary

Treatment of patients with beta thalassemia in North America has altered dramatically during the past 40 years, with improvements in transfusion therapy and introduction of iron chelation therapy. Thalassemia patients now enjoy an increased life expectancy to the fifth and sixth decades of life, with fertility and childbearing becoming important issues. Data regarding this important topic remain limited, without clear data regarding iron control including serial assessment of hepatic iron concentration, the need for assistance in becoming pregnant, and use of iron chelating agents during pregnancy. As the life expectancy increases and overall health improves in thalassemia, clear data on fertility, pregnancy complications, and the effect of pregnancy on maternal health in thalassemia patients are necessary since these will have a direct impact on patient care, quality of life, and patient expectations.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
Last Updated

May 18, 2006

Status Verified

July 1, 2005

First QC Date

May 17, 2006

Last Update Submit

May 17, 2006

Conditions

Eligibility Criteria

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

You may qualify if:

  • Thalassemia, thalassemia intermedia or E-thalassemia patients in Toronto
  • Subject has attempted conception

You may not qualify if:

  • Subject has any other form of blood disease
  • Subject has not attempted conception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Thalassemia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Nancy F Olivieri, MD

    University Health Network, Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Apostoli, B.Sc.

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 18, 2006

Study Start

July 1, 2005

Last Updated

May 18, 2006

Record last verified: 2005-07

Locations