A study to test the efficacy and safety of IMMUNORHO in the prevention of immune response of Rh(D) negative Women Pregnant with Rh(D) positive Foetuses

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 276

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 25 (from day 0 to day 7) to 26 (day 7) weeks 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 276
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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