Clinical trial NCT01666249: 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
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Pregnancy; Fetomaternal Hemorrhage
Keywords: FMH; anti-Rh; efficacy
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
Collaborators: name: Panamerican Medical Supply
First posted: 2012-08-16
Enrollment: 347
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Negative result for coombs test up to six months after immunization
timeFrame: up to six months
Secondary outcomes:
measure: Adverse Events Report
timeFrame: up to six months
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand
state: Ceara
city: Cuiaba
country: Brazil
facility: Instituto Tropical de Medicina Reprodutiva e Menopausa -INTRO
state: Mato Grosso
city: Canoas
country: Brazil
facility: Associação Educadora São Carlos AESC - Centro de Pesquisa HRPC
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas (Puc-Rs)
state: Rio Grande Do Sul
Study officials:
affiliation: Azidus Brasil Scientific Research and Development Ltda
name: Regina M Doi, physician
role: STUDY_DIRECTOR
References: