Kintampo

Researchers are evaluating the long-term safety and effectiveness of etavopivat, a new oral medicine being developed to treat inherited blood disorders such as sickle cell disease and thalassemia. These disorders affect hemoglobin, the protein responsible for carrying oxygen in the body. This phase 3 study aims to monitor how well etavopivat works and its safety profile over an extended period. Participants will receive one of three forms of etavopivat (A, B, or C) as oral doses. The study is open-label and multicenter, involving adults, adolescents, and children who have previously completed treatment in an etavopivat parent study and continue to benefit clinically. The treatment period can last up to 264 weeks but may end earlier if etavopivat is approved in the participant's country. During the study, researchers will track the number of treatment-emergent adverse events and adverse reactions for each participant by indication and age group from baseline through the end of the study, which can last up to 316 weeks. Participants' safety and response to long-term treatment will be closely monitored throughout this period.

Researchers are evaluating how well etavopivat works to reduce the number of vaso-occlusive crises (painful blood vessel blockages) in adolescents and adults living with sickle cell disease. The study also aims to assess if etavopivat can decrease organ damage, improve exercise tolerance, and reduce fatigue. This is a global Phase 3 study involving participants aged 12 years and older with confirmed sickle cell disease. The study is randomized, double-blind, and placebo-controlled to ensure accurate evaluation of the treatment effects. Participants will receive either etavopivat or a matching placebo by mouth. Which treatment they receive is determined randomly. The study will last about two years, during which participants will take the assigned medication and be monitored closely. Etavopivat is an investigational drug currently under evaluation in multiple studies for sickle cell disease. During the study, participants will have regular assessments including documentation of vaso-occlusive crisis events, blood tests, and physical evaluations. Researchers will track the number of crises that require medical attention over a 52-week period, as well as measures of organ health, exercise ability, and fatigue. Safety and overall health will be monitored throughout the study, with the total participation time lasting approximately two years.

Researchers are evaluating the effectiveness and safety of different anti-malarial drugs in adults, adolescents, and children with uncomplicated Plasmodium falciparum malaria. This study aims to assess how well these medications kill the malaria parasite and their potential to cure the infection, while also studying how well the drugs are tolerated and how they behave in the body to determine appropriate dosing for future research. The study is a multi-part, multi-center platform trial in Phase 2. Participants may receive one or a combination of oral anti-malarial agents, including INE963, KAE609 (Cipargamin), KLU156 (a combination of KAF156 and lumefantrine), or the standard of care drug Coartem. Treatments are given either alone or in combination, and different parts of the study include specific age and weight groups to evaluate these drugs. The study includes several parts, with participants receiving assigned treatments and being monitored closely. During the study, participants will have their parasite levels checked up to day 7 to measure how quickly the infection clears. On day 29, researchers will evaluate the clinical and parasitological response using polymerase chain reaction (PCR) tests. Participants will undergo various assessments including parasite counts, vital signs, and safety monitoring. The study involves detailed follow-up to assess treatment effectiveness and safety over time, with the total participation duration depending on the study part.

Access to quality antenatal care (ANC) and postnatal care (PNC) is essential to reducing health problems related to pregnancy and supporting positive birth experiences. The World Health Organization recommends eight ANC visits for pregnant women, but many vulnerable groups still have low coverage and inconsistent care quality. This study aims to better understand pregnancy risk factors and their link to outcomes like stillbirth, neonatal death, and maternal complications, especially in low- and middle-income countries, to help improve future maternal and newborn health strategies. The study observes pregnant women starting before 20 weeks of gestation, following them through delivery and postpartum periods. It collects data to track maternal mortality, severe maternal outcomes, anemia, stillbirth, neonatal mortality, preterm birth, low birth weight, and small-for-gestational-age babies. The study does not involve specific treatments but gathers information to evaluate risks and outcomes in different settings. Participants will provide informed consent and live within the study areas in Ghana, Kenya, Pakistan, Zambia, or India. Researchers will monitor pregnancy progress via ultrasound and assess outcomes from pregnancy identification through delivery and up to 12 months postpartum. The study aims to create a combined data set to improve understanding of risks and guide innovations to improve health for mothers and their newborns.

Researchers are evaluating the safety and effectiveness of the RTS,S/AS01 malaria vaccine through case-control studies embedded in the Malaria Vaccine Pilot Evaluation (MVPE) program conducted in Ghana, Kenya, and Malawi. This research focuses on measuring vaccine safety with attention to cerebral malaria, meningitis, and severe malaria, as well as assessing the vaccine's impact on all-cause mortality in boys and girls. The study also aims to support the use of case-control methods by immunization and malaria control programs. The study includes two main case-control components: one for clinical outcomes and one for mortality outcomes. Children aged 6 months to 59 months living in areas where the malaria vaccine is being implemented are enrolled as cases and controls. For each case identified through sentinel hospital surveillance or mortality verbal autopsies, four neighborhood controls are selected and interviewed. Data collection involves administering questionnaires at participants' homes to gather clinical and demographic information. The case-control studies will run for 45 months, recruiting thousands of cases and controls to provide strong statistical power for detecting differences in safety and mortality outcomes. Participants and their caregivers will be involved in consenting and providing information during home visits. The study collects data on diagnoses of meningitis, severe malaria, cerebral malaria, and death by gender over an average of one year. Researchers track and compare these outcomes between vaccinated and unvaccinated children using the case-control design. This approach allows monitoring vaccine safety and effectiveness while building local capacity for such evaluations.

Researchers are evaluating the safety and effectiveness of rilzabrutinib in people aged 10 to 65 years with sickle-cell disease (SCD). This multicenter study is a phase 3, randomized, double-blind, placebo-controlled trial designed to assess rilzabrutinib’s impact on clinical vaso-occlusive crises (VOC) over a 52-week period, followed by an open-label long-term extension (LTE) phase. Participants include adults and children who have had multiple VOC episodes and meet specific health criteria. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo tablets during the 52-week double-blind period (Part A). About half of the participants enrolled initially will be adults until an interim analysis is completed, after which both adults and children will be enrolled. Those who complete Part A may continue into the open-label LTE period (Part B), which lasts up to 52 weeks from the first participant’s entry into this phase. Treatment dosing remains stable and consistent throughout the study. During the study, participants will visit the study sites regularly based on a set schedule for assessments. Researchers will monitor the annualized rate of clinical VOC events at week 52 as the primary outcome. Safety and efficacy will be evaluated through medical exams, laboratory tests, and ongoing health monitoring. Participants' use of hydroxyurea and L-glutamine will be recorded, and adherence to stable dosing will be maintained throughout. The study aims to provide long-term safety and efficacy data on rilzabrutinib for this population.