Bairro Ingombota, Angola

  • LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

    The proposed project is a prospective, randomized controlled study to evaluate the effects of daily low dose aspirin in pregnant women with Sickle Cell Disease at the first trimester versus the second trimester of the gestation period. The study will include 450 female participants of all ages, in multiple maternity hospitals in Luanda, Angola, with an official diagnosis of Sickle Cell Disease and confirmed pregnancy. Patients who consent to take part in the study will be given 100 mg aspirin once daily either at the first trimester (6-13 weeks) or the second trimester (14-27 weeks) of the gestation period. Up to 450 participants will be randomly assigned in a 1:1 ratio to the two study treatment trimester groups (225 starting the low dose of aspirin at the first trimester and 225 starting the low dose of aspirin at the second trimester). In both treatment arms, daily use of low dose aspirin will be prescribed/administered until week 36 or time of delivery, whichever comes earlier. Study Duration: Each participant will be enrolled in the study for the duration of the pregnancy as follow: Screening Visit Randomized Treatment Period Follow Up Period (6 weeks postpartum)

    Phase

    1/2

    Span

    105 weeks

    Sponsor

    Instituto Nacional de Investigacao em Saude, Angola

    Luanda

    Recruiting

  • Study of the Role of Genetic Modifiers in Hemoglobinopathies

    Hemoglobinopathies, including sickle cell disease (SCD) and beta-thalassemia, are prevalent diseases with variable clinical manifestation and severity that are thought to be governed, in part, by genetic modifiers. Despite the identification and characterization of a few putative genetic modifiers by previous studies, these are as yet insufficient to guide treatment recommendations or risk-stratify patients reliably. Also, it is expected that many additional genetic variants exist that can modify disease and its severity. This large-scale genome-wide association study (GWAS) will utilize SNP chips to investigate the genetic profile of individuals with hemoglobinopathies, thereby addressing the challenges of previous studies related to small sample sizes and low statistical power, while promoting the participation of diverse populations worldwide. The study aims to i) discover new genetic modifiers of hemoglobinopathies, ii) validate previously reported genetic modifiers, iii) pool and analyze existing genomic data, iv) standardize phenotypic descriptions, v) develop a research resource of disease-specific data generated in INHERENT, including genomic, phenotypic, and functional data, and vi) develop risk scores that can be used for patient stratification. The main endpoints include: 1. Worldwide demography, including numbers of patients, main genotypes, and overall disease severity/burden in participating centres 2. Genetic modifiers affecting clinical or laboratory phenotypes of hemoglobinopathies, including 1. overall survival in SCD and/or thalassemia, 2. stroke and/or decreased neurocognitive function in SCD and/or thalassemia, 3. renal impairment in SCD and/or thalassemia, 4. leg ulcers in SCD, 5. priapism in SCD, 6. mild or severe acute pain and/or chronic pain syndromes in SCD, 7. pulmonary hypertension in SCD and/or thalassemia, 8. hyperhemolysis in SCD and/or thalassemia, 9. fetal hemoglobin levels, 10. degree of ineffective erythropoiesis, 11. hepatic fibrosis/cirrhosis and/or cardiac siderosis, 3. Genetic modifiers affecting response to treatment, including 1. response to hydroxyurea, 2. response to iron chelation treatment, 3. response to emerging therapeutic agents

    Phase

    N/A

    Span

    261 weeks

    Sponsor

    Cyprus Institute of Neurology and Genetics

    Luanda

    Recruiting

  • Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa

    The Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa (PUSHUP) trial is a prospective, randomized clinical trial of hydroxyurea for 400 children with SCA in Luanda, Angola. The study will prospectively evaluate the safety and efficacy of hydroxyurea with limited laboratory monitoring and will bring precision medicine to children with SCA using several novel features including measurement of hydroxyurea using a battery-powered HPLC machine and individualized dose calculations using an automated computer-based algorithm. The objective of this study is to establish evidence-based guidelines for hydroxyurea in sub-Saharan Africa, including appropriate dosing and laboratory monitoring strategy with the goal of allowing for widespread use of hydroxyurea across sub-Saharan Africa, regardless of clinical or laboratory resources.

    Phase

    3

    Span

    198 weeks

    Sponsor

    Brown University

    Luanda

    Recruiting

  • iCaReMe Global Registry

    The registry intends to provide real world data on patient management and quality of care for patients with T2DM, hypertension, heat failure and chronic kidney disease in clinical practice in many countries. To bridge this gap an observational voluntary registry is set up to capture real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart Failure and Chronic Kidney Disease. Multinational, observational registry utilizing a cloud-based eCRF, for prospective and retrospective data collection, accessible to investigators and Scientific Committee. This registry will be open to all physicians managing T2DM, HTN, HF or CKD across the world.

    Phase

    N/A

    Span

    411 weeks

    Sponsor

    AstraZeneca

    Luanda

    Recruiting

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