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

Primary Purpose

Pregnancy; Fetomaternal Hemorrhage

Status

Suspended

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Immunoglobulin Anti-RhD

About this trial

This is an interventional prevention trial for Pregnancy; Fetomaternal Hemorrhage focused on measuring FMH; anti-Rh; efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand
Instituto Tropical de Medicina Reprodutiva e Menopausa -INTRO
Associação Educadora São Carlos AESC - Centro de Pesquisa HRPC
Hospital de Clínicas de Porto Alegre
Hospital São Lucas (Puc-Rs)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Immunoglobulin Anti-RhD

Arm 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01666249

First Posted

July 25, 2012

Last Updated

November 1, 2022

Sponsor

Azidus Brasil

Collaborators

Panamerican Medical Supply

1. Study Identification

Unique Protocol Identification Number

NCT01666249

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Suspended

Why Stopped

Suspended for indetermined period.

Study Start Date

April 2014 (Actual)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

December 2020 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Azidus Brasil

Collaborators

Panamerican Medical Supply

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy; Fetomaternal Hemorrhage

Keywords

FMH; anti-Rh; efficacy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

347 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immunoglobulin Anti-RhD

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Immunoglobulin Anti-RhD

Other Intervention Name(s)

KamRho-D

Intervention Description

Primary Outcome Measure Information:

Title

Negative result for coombs test up to six months after immunization

Description

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

Time Frame

up to six months

Secondary Outcome Measure Information:

Title

Adverse Events Report

Description

Time Frame

up to six months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Regina M Doi, physician

Organizational Affiliation

Azidus Brasil Scientific Research and Development Ltda

Official's Role

Study Director

Facility Information:

Facility Name

Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand

City

Fortaleza

State/Province

Ceara

ZIP/Postal Code

60430-270

Country

Brazil

Facility Name

Instituto Tropical de Medicina Reprodutiva e Menopausa -INTRO

City

Cuiaba

State/Province

Mato Grosso

ZIP/Postal Code

78043-306

Country

Brazil

Facility Name

Associação Educadora São Carlos AESC - Centro de Pesquisa HRPC

City

Canoas

State/Province

Rio Grande Do Sul

ZIP/Postal Code

92425-900

Country

Brazil

Facility Name

Hospital de Clínicas de Porto Alegre

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Hospital São Lucas (Puc-Rs)

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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