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

Phase 3

Suspended

• Conditions: Pregnancy; Fetomaternal Hemorrhage
• Interventions: Biological: Immunoglobulin Anti-RhD

• Registration Number: NCT01666249
• Lead Sponsor: Azidus Brasil

Brief 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).

Study Timeline

• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-16
• Study Start: 2014-04
• Primary Completion: 2014-11
• Study Completion: 2020-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 347

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immunoglobulin Anti-RhD	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).

Primary Outcome Measures

Name	Time	Method
Negative result for coombs test up to six months after immunization	up to six months	Will be evaluated by proportion of participants that presented negative result for coombs test until six months after passive immunization with investigational product.

Secondary Outcome Measures

Name	Time	Method
Adverse Events Report	up to six months	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.

Trial Locations

Locations (5)

Instituto Tropical de Medicina Reprodutiva e Menopausa -INTRO; 🇧🇷 Cuiaba, Mato Grosso, Brazil

Associação Educadora São Carlos AESC - Centro de Pesquisa HRPC; 🇧🇷 Canoas, Rio Grande Do Sul, Brazil

Hospital São Lucas (Puc-Rs); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand; 🇧🇷 Fortaleza, Ceara, Brazil