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

Azidus

Status and phase: Suspended; Phase 3

Conditions: Pregnancy; Fetomaternal Hemorrhage

Treatments: Biological: Immunoglobulin Anti-RhD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01666249

IMUPAN1011

Emenda 3.0 - 19/09/2017 (Other Identifier)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 347 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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347 participants in 1 patient group

Immunoglobulin Anti-RhD

Experimental group

Description:

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).

Treatment:

Biological: Immunoglobulin Anti-RhD