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Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas

NCT03128515 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2020-02-20

No results posted yet for this study

Summary

The Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM) study is the first placebo-controlled randomized clinical trial of hydroxyurea treatment in a malaria endemic region. NOHARM has now achieved full enrollment; all children have completed the blinded portion of the protocol and are in the open-label study treatment portion.

This extension study of maximum tolerated dose (MTD), addresses the next critical set of questions about the optimal dosing and monitoring of hydroxyurea treatment for children with SCA in low-resource settings. By providing guidance about optimal hydroxyurea treatment, the NOHARM MTD Study will directly inform policies that can transform the health of African children living with SCA.

Conditions

Interventions

DRUG

Hydroxyurea

Administered once a day in tablet form (100mg or scored 1000mg) for 24 months

Sponsors & Collaborators

  • Doris Duke Charitable Foundation

    collaborator OTHER

  • Makerere University

    collaborator OTHER

  • Mulago Hospital, Uganda

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Chandy C John, M.D. · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
72 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2019-04-07
Completion
2020-01-28

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03128515 on ClinicalTrials.gov