Pregnancy; Fetomaternal Hemorrhage Clinical Trial
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.
| Verified date | November 2022 |
| Source | Azidus Brasil |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Suspended |
| Enrollment | 347 |
| Est. completion date | December 2020 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Associação Educadora São Carlos AESC - Centro de Pesquisa HRPC | Canoas | Rio Grande Do Sul |
| Brazil | Instituto Tropical de Medicina Reprodutiva e Menopausa -INTRO | Cuiaba | Mato Grosso |
| Brazil | Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand | Fortaleza | Ceara |
| Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital São Lucas (Puc-Rs) | Porto Alegre | Rio Grande Do Sul |
| Lead Sponsor | Collaborator |
|---|---|
| Azidus Brasil | Panamerican Medical Supply |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |