NCT01666249

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 and Coombs Negative Women at Sensitization Risk.

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 347 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This a open, prospective, multicenter, single-arm, phase III study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization. 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).

Detailed description

This a phase III study in which women participants with RH and Coombs negative will receive only one dose of 1500 IU anti-Rh immunoglobulin intramuscularly up to 72 hours post exposition (child-birth) and will be following until 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).

Conditions

• Pregnancy; Fetomaternal Hemorrhage

Interventions

Type	Name	Description
BIOLOGICAL	Immunoglobulin Anti-RhD	Participants will receive a single intramuscular administration of 300 mcg/2mL, correponding 1500 UI of Human Immunoglobulin Anti-RhD (Kamrho-D - Panamerican), up to 72 hours post exposition (child-birth).

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-11-01
• Completion: 2020-12-01
• First posted: 2012-08-16
• Last updated: 2022-11-02

Locations

5 sites across 1 country: Brazil