E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
Isoimmunization of RhD negative mothers with a RhD positive foetus |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039038 |
E.1.2 | Term | Rhesus isoimmunization |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Russian Federation |
Czechia |
Hungary |
Italy |
Poland |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |