NCT07116772

Brief Summary

The SAFE study is a long-term research project that watches people with sickle cell anemia (SCA) over time. The main goal is to see how a medicine called hydroxyurea affects their growth, puberty, and ability to have children. A second goal is to see how hydroxyurea affects pregnancy outcomes, by comparing people who take the medicine to those who don't.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
116mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
3 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jul 2023Dec 2035

Study Start

First participant enrolled

July 10, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2035

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

February 4, 2026

Status Verified

August 1, 2025

Enrollment Period

11.9 years

First QC Date

July 23, 2025

Last Update Submit

February 3, 2026

Conditions

Sickle Cell Anemia

Keywords

HydroxyureaFertilitySickle Cell Disease

Outcome Measures

Primary Outcomes (1)

  • Clinical Outcomes

    The number of people who experience serious health events like pregnancy, stroke, cancer, or death.

    From enrollment up to 10 years after enrollment.

Secondary Outcomes (12)

  • Female Reproductive Potential and Outcomes

    From enrollment up to 10 years after enrollment.

  • Female Reproductive Potential and Outcomes

    From enrollment up to 10 years after enrollment.

  • Female Reproductive Potential and Outcomes

    From enrollment up to 10 years after enrollment.

  • Female Reproductive Potential and Outcomes

    From enrollment up to 10 years after enrollment.

  • Female Reproductive Potential and Outcomes

    From enrollment up to 10 years after enrollment.

  • +7 more secondary outcomes

Study Arms (1)

Sickle Cell Anemia

Those with sickle cell anemia (SCA).

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with sickle cell anemia who are at least 8 years old and seen in Jamaica and Dominican Republic.

You may qualify if:

  • Patients with documented sickle cell anemia (SCA).
  • At least 8 years of age at the time of enrollment.
  • Enrolled on the EXTEND or SACRED study.
  • Provide informed consent.
  • Able to take part in all parts of the study, including treatments, check-ups, and follow-up visits.

You may not qualify if:

  • Currently taking part in another treatment study (not EXTEND or SACRED).
  • Has received other treatments for sickle cell disease in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centro de Obstetricia y Ginecologia

Santo Domingo, Dominican Republic

RECRUITING

Caribbean Institute for Health Research, University of West Indies

Kingston, Jamaica

RECRUITING

Buganda Medical Centre

Mwanza, Tanzania

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and FTA dried blood spots.

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Russell E Ware, MD, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Latham, DrPh

CONTACT

513-803-7822Teresa.Latham@cchmc.org

Russell E Ware, MD, PhD

CONTACT

513-803-4597Russell.Ware@cchmc.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2025

First Posted

August 12, 2025

Study Start

July 10, 2023

Primary Completion (Estimated)

May 19, 2035

Study Completion (Estimated)

December 31, 2035

Last Updated

February 4, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Study data will be collected and managed using REDCap™ electronic data capture tools. REDCap™ is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. The REDCap™ system is available for use through institutions participating in the REDCap™ consortium. Cincinnati Children's Hospital Medical Center serves as the home institution to allow the REDCap™ system for de-identified data collection in the SAFE study.

Locations

DO(1)TA(1)JA(1)