WHO ICTRP trial

Anti-human globulin Rh D drug from effectiveness from review after vaccination…

RBR-27sdv5 · Registro Brasileiro de Ensaios Clinicos (ReBEC) · Recruiting

Key facts

Trial ID RBR-27sdv5
Public title Anti-human globulin Rh D drug from effectiveness from review after vaccination in women with postpartum negative factor blood and with complications risk in newborns
Scientific title Evaluation of clinical efficacy of Kamrho-D® drug (anti-human globulin Rh D - Panamerican) in postpartum women Rh negative immunization, coombs indirect negative and sensitization risk
Primary sponsor Hospital São Lucas da PUC/RS (Centro Coordenador)
Secondary sponsors LAL Clinica Pesquisa e Desenvolvimento Ltda.
Registry Registro Brasileiro de Ensaios Clinicos (ReBEC)
Recruitment status Recruiting
Study type Intervention
Phase 3
Countries Brazil
Conditions postpartum women with blood type negative Rh and indirect coombs test negative, whose newborn is positive Rh;D12.776.124.486.485.114.619.393.700
Interventions Study multicenter, prospective and non-comparative. They will be selected 232 female participants, puerperae with a negative Rh factor. The participants will receive a single dose of the drug (anti-Rh D human immunoglobulin), administered…
Registration date Feb 3, 2016
Registry page ensaiosclinicos.gov.br

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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