Pregnancy; Fetomaternal Hemorrhage
Conditions
Keywords
FMH; anti-Rh; efficacy
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).
Interventions
BIOLOGICALImmunoglobulin Anti-RhD
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).
Sponsors
Panamerican Medical Supply
Azidus Brasil
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative result for coombs test up to six months after immunization | up to six months | Will be evaluated by proportion of participants that presented negative result for coombs test until six months after passive immunization with investigational product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Report | up to six months | 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. |
Countries
Brazil
Outcome results
None listed