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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Evaluation of the Clinic Efficacy of Immunoglobulin Anti-RhD KamRho-D® (Panamerican) in Postpartum Immunization of Rh and Coombs Negative Women at Sensitization Risk.

Conditions
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Pregnancy; Fetomaternal Hemorrhage

Intervention / Treatment
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* Biological: Immunoglobulin Anti-RhD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Agree to participate, sign and date ICF; 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 at 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunoglobulin Anti-RhD<br>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). | Biological: Immunoglobulin Anti-RhD<br>* 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).<br>* Other names: KamRho-D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative result for coombs test up to six months after immunization | Will be evaluated by proportion of participants that presented negative result for coombs test until six months after passive immunization with investigational product. | up to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events Report | Safety of human immunoglobulin anti-RhD will be verified through adverse events reported by participants throughout study. The adverse events will be classified about the type, frequency, intensity, seriousness, severity and relation to the study drug. | up to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMH; anti-Rh; efficacy