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Hydroxyurea Treatment for Adult Sickle Cell Anemia Patients in Kinshasa

NCT05681598 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2023-01-12

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy of hydroxyurea (HU) in improving disease severity in adult patients with sickle cell anemia in Kinshasa (Democratic Republic of Congo). This study aims to:

* assess the safety and efficacy of HU treatment in the Congolese environment;
* assess the reversibility of chronic cardiac lesions. Participants will take hydroxyurea for two years. The effects of the treatment will be evaluated periodically by clinical evaluation, biological tests, and echocardiographic exploration.

Conditions

  • Sickle-Cell Anaemia

Interventions

DRUG

Hydroxyurea

The treatment started with a dose of 15mg/kg/day of HU. This initial dose was increased in steps of 5mg/kg/day every three months up to 35mg/kg/day or a maximal tolerated dose.

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • University of Kinshasa

    lead OTHER

Principal Investigators

  • Prosper Lukusa Tshilobo · Center of human genetics. Faculty of medicine. University of Kinshasa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-30
Primary Completion
2020-05-16
Completion
2020-05-16

Countries

  • Democratic Republic of the Congo

Study Locations

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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 NCT05681598 on ClinicalTrials.gov