Text Size

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Prevention of Rh Sensitization During Pregnancy
 Biological: Immunoglobulin Anti-RhD
Biological: Rhophylac
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Incidence, intensity, type and frequence of adverse event. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 232
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • KamRho-D
  • Rhophylac
Active Comparator: Rhophylac
Rhophylac (CSL Behring)
 Biological: Rhophylac
Single dose (300 mcg/2 mL), via intramuscular, up to 72h after delivery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666249

Contacts
Contact: Alexandre Frederico +55 11 38716399 alexandre@lalclinica.com.br

Locations
Brazil
Hospital São Lucas (Puc-Rs) Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Contact     +55 51 3320-3479     obstetriciapucrs@hotmail.com    
Principal Investigator: Julia de Barros Machado            
Cepes - Faculdade de Medicina Do Abc Not yet recruiting
Santo André, São Paulo, Brazil, 09060-650
Contact: Edna Oliveira de Souza     +55 11 49935410     cepes@fmabc.br    
Principal Investigator: Mauro Sancovski            
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Investigators
Study Director: Alexandre Frederico, Physician L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01666249     History of Changes
Other Study ID Numbers: IMUPAN1011, Version 1 from 1/10/2011
Study First Received: July 25, 2012
Last Updated: August 10, 2012
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Rh Isoimmunization
Blood Group Incompatibility
Hematologic Diseases
Immune System Diseases
Immunoglobulins
Antibodies
 Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013