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

This study is currently recruiting participants.
Verified April 2016 by Azidus Brasil
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666249
First Posted: August 16, 2012
Last Update Posted: April 8, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Panamerican Medical Supply Suprimentos Médicos Ltda.
Information provided by (Responsible Party):
Azidus Brasil
July 25, 2012
August 16, 2012
April 8, 2016
February 2013
November 2016   (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 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. ]
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. ]
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 ]
Same as current
Not Provided
Not Provided
 
Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization Risk.
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.
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.
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).
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pregnancy; Fetomaternal Hemorrhage
Biological: Immunoglobulin Anti-RhD
KamRho-D (Immunoglobulin Anti-RhD): single dose (300mcg/2mL), via intramuscular, up to 72h after delivery.
Other Name: KamRho-D
Experimental: Immunoglobulin Anti-RhD
KamRho-D (Panamerican)
Intervention: Biological: Immunoglobulin Anti-RhD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
232
November 2017
November 2016   (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;
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact: Alexandre Frederico +55 11 38716399 alexandre@lalclinica.com.br
Brazil
 
 
NCT01666249
IMUPAN1011
Yes
Not Provided
Plan to Share IPD: Undecided
Azidus Brasil
Azidus Brasil
Panamerican Medical Supply Suprimentos Médicos Ltda.
Study Director: Alexandre Frederico, Physician Azidus Brasil
Azidus Brasil
April 2016

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