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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Azidus Brasil
Sponsor:
Collaborator:
Panamerican Medical Supply Suprimentos Médicos Ltda.
Information provided by (Responsible Party):
Azidus Brasil
ClinicalTrials.gov Identifier:
NCT01666249
First received: July 25, 2012
Last updated: April 7, 2016
Last verified: April 2016
  Purpose
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). This a immunization study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization.

Condition Intervention Phase
Pregnancy; Fetomaternal Hemorrhage
Biological: Immunoglobulin Anti-RhD
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Clinic Efficacy of Immunoglobulin Anti-RhD KamRho-D® (Panamerican) in Postpartum Immunization of Rh-negative and Coombs Negative Women at Sensitization Risk.

Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • The primary endpoint will be the maintenance of the negative result for the indirect Coombs test 06 months after delivery, proving that the test drug had the same ability to neutralize possible fetal red blood cells. [ Time Frame: 72 (+6) hours after immunization; 90 days after immunization and 180 days after immunization. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence, intensity, type and frequence of adverse event. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 232
Study Start Date: February 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immunoglobulin Anti-RhD
KamRho-D (Panamerican)
Biological: Immunoglobulin Anti-RhD
KamRho-D (Immunoglobulin Anti-RhD): single dose (300mcg/2mL), via intramuscular, up to 72h after delivery.
Other Name: KamRho-D

Detailed Description:
This a immunization, non-randomized phase III study in which women participants with RH and Coombs negative receive only one dose of 1500 IU anti-Rh immunoglobulin intramuscularly and will be following during 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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agree to participate, sign and date the Informed Consent;
  • 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 in 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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666249

Contacts
Contact: Alexandre Frederico +55 11 38716399 alexandre@lalclinica.com.br

Locations
Brazil
Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand Recruiting
Fortaleza, Ceara, Brazil, 60430-270
Contact: Daisy Lucena       daisydelucena@yahoo.com.br   
Sub-Investigator: Francisco Edson de Lucena Feitosa, MD         
Instituto Tropical de Medicina Reprodutiva e Menopausa -INTRO Recruiting
Cuiaba, Mato Grosso, Brazil, 78043-306
Contact: Jacklyne Silva Barbosa       jacklynepesquisa@yahoo.com.br   
Sub-Investigator: Sebastião Freitas de Medeiros, MD         
Associação Educadora São Carlos AESC - Centro de Pesquisa HRPC Recruiting
Canoas, Rio Grande do Sul, Brazil, 92425-900
Contact: Heveline Roesch       heveline.roesch@hrpc.com.br   
Sub-Investigator: Tiane Nogueira Salum, MD         
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact       vlfreitas@hcpa.edu.br   
Contact: Vera Lorentz         
Sub-Investigator: Eduardo Pandolfi Passos, MD         
Hospital São Lucas (Puc-Rs) Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Contact: Aline Cássia Santos    +55 51 3320-3479    dq.acassia@gmail.com   
Principal Investigator: Breno José Acauan Filho, MD         
Sponsors and Collaborators
Azidus Brasil
Panamerican Medical Supply Suprimentos Médicos Ltda.
Investigators
Study Director: Alexandre Frederico, Physician Azidus Brasil
  More Information

Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT01666249     History of Changes
Other Study ID Numbers: IMUPAN1011 
Study First Received: July 25, 2012
Last Updated: April 7, 2016
Health Authority: Brazil: National Health Surveillance Agency
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Azidus Brasil:
FMH; anti-Rh; efficacy

Additional relevant MeSH terms:
Hemorrhage
Fetomaternal Transfusion
Pathologic Processes
Anemia, Neonatal
Anemia
Hematologic Diseases
Infant, Newborn, Diseases
Vaccines
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 06, 2016