Non-inferiority of Immunoglobulin Anti-RhD KamRho-D® Compared to Rhopphylac® in Postpartum Immunization of Rh-negative, Coombs Negative Women at Risk of Sensitization.

Condition(s) targeted: Prevention of Rh Sensitization During Pregnancy

Intervention: Immunoglobulin Anti-RhD (Biological); Rhophylac (Biological)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Official(s) and/or principal investigator(s):
Alexandre Frederico, Physician, Study Director, Affiliation: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Overall contact:
Alexandre Frederico, Phone: +55 11 38716399, Email: alexandre@lalclinica.com.br

The hypothesis of this trial is that the test drug (KamRho-D ® - T) is not inferior to the

comparator drug (Rhophylac ® - C) for immunization of Rh negative mothers at risk of

sensitization. The primary aim is to evaluate the clinical non-inferiority of the test drug

(KamRho-D ® - Panamerican) compared to the comparator drug (Rhophylac ® - CSL Behring) after

passive immunization in Rh-negative mothers, negative indirect Coombs, whose baby is Rh positive, through the incidence of non positivization of the indirect Coombs test 06 months after delivery. The secondary objective is to assess aspects of drug safety, such as: type, frequency and intensity of adverse events between groups.

Official title: Phase III Study of the Evaluation of the Non-inferiority of Immunoglobulin Anti-RhD KamRho-D® (Panamerican) Compared to Rhopphylac® (CSL Behring)in Postpartum Immunization of Rh-negative, Coombs Negative Women at Risk of Sensitization.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Primary outcome: The primary endpoint will be the maintenance of the negative result for the indirect Coombs test 06 months after delivery, proving that the test drug and the comparator drug had the same ability to neutralize possible fetal red blood cells.

Secondary outcome: Incidence, intensity, type and frequence of adverse event.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Agree to participate, sign and date the Informed Consent;

- 18 years old or older;

- Mothers who are Rh-negative, negative indirect Coombs analyzed by gel agglutination

method, whose just deliveries Rh positive baby. Exclusion Criteria:

- Be participating simultaneously or have participated in another clinical trial within

the last 12 months;

- Mothers who are allergic to any components of the formula;

- Mothers who have a history of IgA deficiency or IgA antibody present;

- Mothers who have a history of autoimmune hemolytic anemia with hemolysis or with

pre-existing risk of hemolysis;

- Mothers who have indirect Coombs test positive in the beginning of the treatment;

- Rh-negative mothers whose delivered Rh-negative babies;

- Abnormalities of the coagulation system;

- Patients who made use of vaccines made with live pathogens in the last 03 months or

will make during the study;

- Patients with clinical diagnosis of prenatal liver and / or severe nephropathy;

- Principal Investigator of the study criteria;

Alexandre Frederico, Phone: +55 11 38716399, Email: alexandre@lalclinica.com.br

Hospital São Lucas (Puc-Rs), Porto Alegre, Rio Grande do Sul 90610-000, Brazil; Not yet recruiting
Phone: +55 51 3320-3479, Email: obstetriciapucrs@hotmail.com
Julia de Barros Machado, Principal Investigator

Cepes - Faculdade de Medicina Do Abc, Santo André, São Paulo 09060-650, Brazil; Not yet recruiting
Edna Oliveira de Souza, Phone: +55 11 49935410, Email: cepes@fmabc.br
Mauro Sancovski, Principal Investigator

Starting date: February 2013
Last updated: August 10, 2012