MedDRA version: 20.0 Level: LLT Classification code 10039038 Term: Rhesus isoimmunization System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: IMMUNORHO
Product Name: IMMUNORHO
Pharmaceutical Form: Solution for injection
INN or Proposed INN: HUMAN ANTI-D IMMUNOGLOBULIN
Other descriptive name: VIRUS INACTIVATED HUMAN ANTI-D IMMUNO
Sponsors
Kedrion S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have voluntarily given written Informed Consent and Authorization to Access Personal Health Information after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 2. Age =18 years at the time of screening. 3. Rh(D) negative. 4. Pregnancy is at week 25 day 0-6 up to week 26 day 0-6 of gestation 5. Negative for anti-D antibodies. 6. Carrying a Rh(D) positive (including Dweak and Dpartial ) foetus as determined by antepartum foetal/maternal non-invasive genotyping. 7. Individuals who can comply with study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior administration of RhD immunoglobulin during the current pregnancy. 2. History of allergies or severe reactions to immunoglobulins or other blood products. 3. Amniocentesis, chorionic villus biopsy, or cordocentesis performed or planned for the current pregnancy. 4. Known clinically relevant maternal or foetal abnormality, such as placenta previa for the current pregnancy. 5. Intra-operative cell salvage performed or planned for the current pregnancy. 6. Blood or blood component transfusion within 6 months of study entry. 7. Diagnosis of selective IgA deficiency with anti-IgA antibody. 8. Participation in any interventional drug/device clinical trial within 30 days or 5 half-lives whatever is longer prior to Informed Consent. 9. Any other medical condition that could interfere with study assessment or interpretation of the data. 10. Multiple pregnancy. 11. Live attenuated viral vaccine administration within 2-4 weeks before IMMUNORHO or planned within 3 months after the last administration of IMMUNORHO. 12. History of malignancy requiring surgery, systemic therapy, or radiation within the prior 5 years or considered not in full remission (except for curatively treated basal or squamous cell carcinoma of the skin or cured cervical carcinoma-in-situ). 13. In the opinion of the Investigator, have issues or concerns that may compromise the safety of the subject, impact the subject’s compliance with the protocol requirements, or confound the reliability of the data acquired. 14. Be a Kedrion, Parexel, clinical site employee, or their close relative regardless of direct involvement in research activities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy objective: To assess the efficacy of IMMUNORHO in the prevention of Rh(D) isoimmunization in Rh(D) negative women pregnant with a Rh(D) positive foetus (including D, Dweak and Dpartial ), as measured by the incidence rate of anti-D antibodies at 24 weeks (corresponding to the 6 months timepoint in the EMA guideline) after last treatment administered;Secondary Objective: Secondary Efficacy objective: To assess the efficacy of IMMUNORHO in the prevention of Rh(D) isoimmunization in Rh(D) negative women pregnant with a Rh(D) positive foetus (including D, Dweak and Dpartial ), as measured by the incidence rate of anti-D antibodies at 12 weeks (corresponding to the 3 months timepoint in the EMA guideline) after last treatment administered Safety Objective: To assess the safety of IMMUNORHO in the prevention of Rh(D) isoimmunization in Rh(D) negative women pregnant with a Rh(D) positive foetus (including D, Dweak and Dpartial ) from Baseline visit to 24 weeks (corresponding to 6 months) after last treatment administered Pharmacokinetic Objective: To characterize the pharmacokinetics (PK) of anti-D immunoglobulin after IMMUNORHO administration in Rh(D) negative pregnant women;Primary end point(s): Primary Efficacy Endpoints Incidence rate of anti-D antibodies evaluated at 24 weeks (corresponding to the 6 months timepoint in the EMA guideline) after treatment (last dose received). ;Timepoint(s) of evaluation of this end point: 24 weeks after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints Incidence rate of anti D antibodies evaluated at 12 weeks (corresponding to the 3 months timepoint in the EMA guideline) after treatment (last dose received).;Timepoint(s) of evaluation of this end point: 12 weeks after treatment | — |
Countries
Czechia, Czech Republic, Hungary, Italy, Poland, Russian Federation
Contacts
Public ContactClinical Trial Manager
Kedrion S.p.A.
Outcome results
None listed