CompletedEarly Phase 1

Fetal Hemoglobin Induction Treatment Metformin

United States37 participantsStarted 2017-03-02

Plain-language summary

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

Age range10 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Confirmed diagnosis of sickle cell anemia
✓. Age greater than or equal to 10 and less than or equal to 60 years of age.
✓. 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.
✓. Creatinine less than or equal to 1.4 mg/dL and estimated glomerular filtration rate greater than 45 ml/min/1.73 m2
✓. Liver function tests (specifically ALT and conjugated bilirubin) less than or equal to 4 times upper limits of normal.

✕. Failure to meet inclusion criteria
✕. Simple or chronic red blood cell transfusion therapy in the last 3 months OR a HbA level greater than 5% in SCA patients
✕. Refusal to use medically effective birth control if female and sexually active.
✕. If on hydroxyurea, not at stable dose of hydroxyurea for a minimum of 4 months (temporary exclusion).
✕. Creatinine greater than 1.4mg/dL
✕. Liver function tests (ALT and conjugated bilirubin) greater than 4 times upper limits of normal.

Change in Fetal Hemoglobin (HbF) Percentage (SCA) or Change in Total Hemoglobin (Hb)

Timeframe: 1 Year

NCT IDNCT02981329

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-20