Fetal Hemoglobin Induction Treatment Metformin



Status:Recruiting
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:12 - 40
Updated:7/13/2018
Start Date:March 2, 2017
End Date:November 2022
Contact:Vivien Sheehan, MD
Email:vxsheeha@texaschildrens.org
Phone:832-824-4459

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Use of Metformin as a Fetal Hemoglobin Inducer in Patients With Hemoglobinopathies

The purpose of this study is to determine whether metformin is effective in the treatment for
sickle cell anemia (SCA) and non-transfusion dependent thalassemia (NTDT).

This is a dose escalation, pilot study for subjects with sickle cell anemia (SCA) disease and
non-transfusion dependent thalassemia (NTDT) to determine if metformin has a beneficial
effect on the treatment and quality of life of SCA and NTDT patients.

Inclusion Criteria:

1. Confirmed diagnosis of sickle cell anemia or non-transfusion dependent thalassemia

2. Age greater than or equal to 12 and less than or equal to 40 years of age.

3. If on hydroxyurea, fetal hemoglobin less than 20% at maximum tolerated dose

4. Creatinine less than or equal to 1.4mg/dL and estimated glomerular filtration rate
greater than 45 ml/min/1.73 m2

5. Liver function tests less than or equal to 3 times upper limits of normal

Exclusion Criteria:

1. Failure to meet inclusion criteria

2. Simple or chronic red blood cell transfusion therapy in the last 3 months OR a HbA
level >5% in SCA patients

3. Pregnancy

4. Refusal to use medically effective birth control if female and sexually active.

5. If on hydroxyurea, not at stable maximum tolerated dose for a minimum of 4 months
(temporary exclusion).

6. Creatinine greater than 1.4mg/dL,

7. Liver function tests greater than 3x upper limits of normal
We found this trial at
2
sites
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Phone: 832-824-4459
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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