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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2020-12-31

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).

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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).

Conditions

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Pregnancy; Fetomaternal Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Immunoglobulin Anti-RhD

Intervention Type BIOLOGICAL

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).

Interventions

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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).

Intervention Type BIOLOGICAL

Other Intervention Names

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KamRho-D

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes