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.

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).

Study Overview

• Status: Suspended
• Conditions: Pregnancy; Fetomaternal Hemorrhage
• Intervention / Treatment: Biological: Immunoglobulin Anti-RhD

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 Type: Interventional
• Enrollment (Anticipated): 347
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Ceara
    • Fortaleza, Ceara, Brazil, 60430-270
      • Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand
  • Mato Grosso
    • Cuiaba, Mato Grosso, Brazil, 78043-306
      • Instituto Tropical de Medicina Reprodutiva e Menopausa -INTRO
  • Rio Grande Do Sul
    • Canoas, Rio Grande Do Sul, Brazil, 92425-900
      • Associação Educadora São Carlos AESC - Centro de Pesquisa HRPC
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Hospital São Lucas (Puc-Rs)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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).; Other Names: KamRho-D

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Collaborators: Panamerican Medical Supply
• Investigators: Study Director: Regina M Doi, physician, Azidus Brasil Scientific Research and Development Ltda

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion: December 1, 2020

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: August 10, 2012
• First Posted (Estimate): August 16, 2012

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: FMH; anti-Rh; efficacy
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Infant, Newborn, Diseases; Anemia; Anemia, Neonatal; Hemorrhage; Fetomaternal Transfusion; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: IMUPAN1011; Emenda 3.0 - 19/09/2017 (Other Identifier: Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No