Suspended

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

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What is being tested

Immunoglobulin Anti-RhD

Biological
Who is being recruted

Anemia+4

+ Anemia, Neonatal

+ Hematologic Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: April 2014
See protocol details

Summary

Principal SponsorAzidus Brasil
Last updated: November 2, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2014

Actual date on which the first participant was enrolled.

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).

NCT01666249
Principal SponsorAzidus Brasil
Last updated: November 2, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

347 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaAnemia, NeonatalHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFetomaternal Transfusion

Criteria

3 inclusion criteria required to participate
18 years old or older
Agree to participate, sign and date ICF
Mothers who are Rh-negative, negative indirect Coombs analyzed by gel agglutination method, whose just deliveries Rh positive baby
10 exclusion criteria prevent from participating
Abnormalities of the coagulation system
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand

Fortaleza, BrazilOpen Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand in Google Maps

Instituto Tropical de Medicina Reprodutiva e Menopausa -INTRO

Cuiabá, Brazil

Associação Educadora São Carlos AESC - Centro de Pesquisa HRPC

Canoas, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil
Suspended5 Study Centers