Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization Risk.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01666249
Recruitment Status : Unknown
Verified April 2016 by Azidus Brasil.
Recruitment status was:  Recruiting
First Posted : August 16, 2012
Last Update Posted : April 8, 2016
Panamerican Medical Supply Suprimentos Médicos Ltda.
Information provided by (Responsible Party):
Azidus Brasil

Brief Summary:
The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific antibodies against factor D and "neutralizes" D antigen present in the Rh-positive fetal red blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh). This a immunization study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization.

Condition or disease Intervention/treatment Phase
Pregnancy; Fetomaternal Hemorrhage Biological: Immunoglobulin Anti-RhD Phase 3

Detailed Description:
This a immunization, non-randomized phase III study in which women participants with RH and Coombs negative receive only one dose of 1500 IU anti-Rh immunoglobulin intramuscularly and will be following during six months to verification of negative Coombs maintenance. Safety evaluation data will include report of all adverse events (including type, frequency, intensity, seriousness, severity and action taken related to the investigational product).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Clinic Efficacy of Immunoglobulin Anti-RhD KamRho-D® (Panamerican) in Postpartum Immunization of Rh-negative and Coombs Negative Women at Sensitization Risk.
Study Start Date : February 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Immunoglobulin Anti-RhD
KamRho-D (Panamerican)
Biological: Immunoglobulin Anti-RhD
KamRho-D (Immunoglobulin Anti-RhD): single dose (300mcg/2mL), via intramuscular, up to 72h after delivery.
Other Name: KamRho-D

Primary Outcome Measures :
  1. 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 had the same ability to neutralize possible fetal red blood cells. [ Time Frame: 72 (+6) hours after immunization; 90 days after immunization and 180 days after immunization. ]

Secondary Outcome Measures :
  1. Incidence, intensity, type and frequence of adverse event. [ Time Frame: 180 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01666249

Contact: Alexandre Frederico +55 11 38716399

Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand Recruiting
Fortaleza, Ceara, Brazil, 60430-270
Contact: Daisy Lucena   
Sub-Investigator: Francisco Edson de Lucena Feitosa, MD         
Instituto Tropical de Medicina Reprodutiva e Menopausa -INTRO Recruiting
Cuiaba, Mato Grosso, Brazil, 78043-306
Contact: Jacklyne Silva Barbosa   
Sub-Investigator: Sebastião Freitas de Medeiros, MD         
Associação Educadora São Carlos AESC - Centro de Pesquisa HRPC Recruiting
Canoas, Rio Grande do Sul, Brazil, 92425-900
Contact: Heveline Roesch   
Sub-Investigator: Tiane Nogueira Salum, MD         
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Vera Lorentz         
Sub-Investigator: Eduardo Pandolfi Passos, MD         
Hospital São Lucas (Puc-Rs) Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Contact: Aline Cássia Santos    +55 51 3320-3479   
Principal Investigator: Breno José Acauan Filho, MD         
Sponsors and Collaborators
Azidus Brasil
Panamerican Medical Supply Suprimentos Médicos Ltda.
Study Director: Alexandre Frederico, Physician Azidus Brasil

Responsible Party: Azidus Brasil Identifier: NCT01666249     History of Changes
Other Study ID Numbers: IMUPAN1011
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Azidus Brasil:
FMH; anti-Rh; efficacy

Additional relevant MeSH terms:
Fetomaternal Transfusion
Pathologic Processes
Anemia, Neonatal
Hematologic Diseases
Infant, Newborn, Diseases
Immunologic Factors
Physiological Effects of Drugs