Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
37 participants
INTERVENTIONAL
2017-03-02
2020-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Hydroxyurea + Metformin
Subjects who are currently taking Hydroxyurea as part of standard of care and have sickle cell anemia.
Metformin
Metfomin will be taken daily. The metformin dose will be increased during two time points per subject if protocol dose escalation criteria is met.
Questionnaires
Questionnaires will be completed to assess the impact quality of life
Group B: Metformin (Group B has closed to enrollment)
Subjects who are not taking Hydroxyurea as part of standard of care and have sickle cell anemia.
Metformin
Metfomin will be taken daily. The metformin dose will be increased during two time points per subject if protocol dose escalation criteria is met.
Questionnaires
Questionnaires will be completed to assess the impact quality of life
Interventions
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Metformin
Metfomin will be taken daily. The metformin dose will be increased during two time points per subject if protocol dose escalation criteria is met.
Questionnaires
Questionnaires will be completed to assess the impact quality of life
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age greater than or equal to 10 and less than or equal to 60 years of age.
3. If on hydroxyurea, fetal hemoglobin less than 20% at a stable dose (mg/kg) determined by the primary hematology provider over at least four months.
4. Creatinine less than or equal to 1.4 mg/dL and estimated glomerular filtration rate greater than 45 ml/min/1.73 m2
5. Liver function tests (specifically ALT and conjugated bilirubin) less than or equal to 4 times upper limits of normal.
2. Simple or chronic red blood cell transfusion therapy in the last 3 months OR a HbA level greater than 5% in SCA patients
3. Refusal to use medically effective birth control if female and sexually active.
4. If on hydroxyurea, not at stable dose of hydroxyurea for a minimum of 4 months (temporary exclusion).
5. Creatinine greater than 1.4mg/dL
6. Liver function tests (ALT and conjugated bilirubin) greater than 4 times upper limits of normal.
10 Years
60 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Baylor College of Medicine
OTHER
Responsible Party
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Titilope Fasipe
Assistant Professor
Principal Investigators
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Titilope Fasipe, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Texas Children's Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Other Identifiers
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H-38457 Metformin
Identifier Type: -
Identifier Source: org_study_id
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