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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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.

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.

Detailed Summary: 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).
Sponsor: Azidus Brasil

Current 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 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. ]

Original 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. [ Time Frame: 72 (+6) hours after immunization; 90 days after immunization and 180 days after immunization. ]

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

Original Secondary Outcome: Same as current

Information By: Azidus Brasil

Dates:
Date Received: July 25, 2012
Date Started: February 2013
Date Completion: November 2017
Last Updated: April 7, 2016
Last Verified: April 2016