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

This study is not yet open for participant recruitment.
Verified August 2012 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Sponsor:
Information provided by (Responsible Party):
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01666249
First received: July 25, 2012
Last updated: August 10, 2012
Last verified: August 2012

July 25, 2012
August 10, 2012
February 2013
February 2015   (final data collection date for primary outcome measure)
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. [ Time Frame: 72 (+6) hours after immunization; 90 days after immunization and 180 days after immunization. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01666249 on ClinicalTrials.gov Archive Site
Incidence, intensity, type and frequence of adverse event. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Non-inferiority of Immunoglobulin Anti-RhD KamRho-D® Compared to Rhopphylac® in Postpartum Immunization of Rh-negative, Coombs Negative Women at Risk of Sensitization.
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Prevention of Rh Sensitization During Pregnancy
  • Biological: Immunoglobulin Anti-RhD
    KamRho-D (Immunoglobulin Anti-RhD): single dose (300mcg/2mL), via intramuscular, up to 72h after delivery.
    Other Names:
    • KamRho-D
    • Rhophylac
  • Biological: Rhophylac
    Single dose (300 mcg/2 mL), via intramuscular, up to 72h after delivery.
  • Experimental: Immunoglobulin Anti-RhD
    KamRho-D (Panamerican)
    Intervention: Biological: Immunoglobulin Anti-RhD
  • Active Comparator: Rhophylac
    Rhophylac (CSL Behring)
    Intervention: Biological: Rhophylac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
232
February 2015
February 2015   (final data collection date for primary outcome measure)

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;
Female
18 Years and older
Yes
Contact: Alexandre Frederico +55 11 38716399 alexandre@lalclinica.com.br
Brazil
 
NCT01666249
IMUPAN1011, Version 1 from 1/10/2011
Yes
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Not Provided
Study Director: Alexandre Frederico, Physician L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP