Fetal Hemoglobin Induction Treatment Metformin

• Status: Completed
• Trial end date: 2020-07-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether metformin is effective in the treatment for sickle cell anemia (SCA).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Pfizer
• Treatments: Hydroxyurea; Metformin

Criteria

Inclusion Criteria:

1. Confirmed diagnosis of sickle cell anemia

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.

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 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.