Hydroxyurea + EPO for Sickle Cell Disease
(ACHiEvE-SCD Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJulia Z Xu, MD, MScGH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Julia Xu

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?The proposed study is a Phase 1/2 multi-center study evaluating the safety and efficacy of erythropoietin (EPO) in combination with hydroxyurea in the treatment of chronic anemia in patients with sickle cell disease (SCD).

Eligibility Criteria

Adults over 18 with confirmed sickle cell disease (HbSS or HbS/β0-thalassemia), not on blood transfusion programs, and without recent use of certain drugs like voxelotor or EPO. Participants must have been on a stable dose of hydroxyurea for at least 60 days and plan to continue it during the trial.

Inclusion Criteria

Screening transferrin saturation ≥ 20% and ferritin ≥ 100 ng/mL

Screening Hb ≤ 9.0 g/dL

I am 18 years old or older.

+3 more

Exclusion Criteria

I have had very high blood pressure on two separate tests.

I have had a blood clot in the last 6 months.

I have not had a serious illness, infection, or pain crisis in the last 2 weeks.

+7 more

Participant Groups

The study is testing the combination of erythropoietin (EPO) with hydroxyurea to treat chronic anemia in sickle cell disease patients. It's a Phase 1/2 trial, meaning they're looking at safety and how well it works across multiple centers.

1Treatment groups

Experimental Treatment

Group I: ErythropoietinExperimental Treatment2 Interventions

Subjects on a stable dose of hydroxyurea will be treated with increasing doses of subcutaneous erythropoietin (EPO) as tolerated for an initial 12 weeks, during which the main safety and efficacy endpoints (including the primary endpoint of hemoglobin response) will be assessed. Subjects may continue on treatment for an additional 12 weeks as clinically indicated, with assessment of additional endpoints at the end of the 24-week study period.

Hydroxyurea is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Hydroxyurea for: