Status:
COMPLETED
Reproductive Capacity and Iron Burden in Thalassemia
Lead Sponsor:
UCSF Benioff Children's Hospital Oakland
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
THALASSEMIA MAJOR
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
The improved long-term survival of thalassemia major (TM) patients has resulted in increased focus on the ability to preserve fertility. While the association of iron toxicity with vital organ dysfunc...
Eligibility Criteria
Inclusion
- Transfusion-dependent\* females and males with thalassemia (any genotype) who are 12 to 45 years of age.
- History of at least 5 years of chronic transfusion (defined as ≥ 8 transfusions/year) (Age of initiation of transfusions does not matter)
- Any pubertal stage.
- Liver iron evaluated by SQUID, MRI or liver biopsy within 12 months prior to enrollment in the study.
- Need to be able to stop hormonal therapy for 3 weeks (males) and one month (females) prior to study enrollment.
Exclusion
- Pregnant or lactating during study enrollment
- Unable to obtain liver iron concentration within 12 months prior or 6 months after study entry.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT02308904
Start Date
June 1 2013
End Date
September 1 2020
Last Update
December 23 2020
Active Locations (1)
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1
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609