Status:
COMPLETED
Pharmacokinetics and Safety of Roledumab in RhD-negative Pregnant Women Carrying an RhD-positive Foetus
Lead Sponsor:
Laboratoire français de Fractionnement et de Biotechnologies
Conditions:
Rh Disease
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to assess the pharmacokinetic profile of Roledumab 300μg IM / IV in RhD-negative pregnant women carrying an RhD-positive foetus. To assess the safety of Roledumab in RhD-nega...
Eligibility Criteria
Inclusion
- Signed and dated informed consent form provided by the subject prior to proceeding with any study-related procedure,
- At least 18 years old,
- Pregnancy between 12 and 27 weeks gestational age as confirmed by early ultrasound,
- Pregnant RhD-negative woman carrying an RhD-positive fetus confirmed by a non-invasive fetal RhD genotyping test,
- Negative serology: HIV (1 and 2), hepatitis C and hepatitis B, except for positive results due to vaccinations,
- Covered by healthcare insurance in accordance with local requirements.
Exclusion
- RhD allo-immunized subject,
- Positive for ADA test,
- Multiple fetuses,
- Occurrence of a documented potential sensitizing event in this pregnancy before the antenatal IMP administration,
- Prior administration of anti-RhD immunoglobulin during the current pregnancy,
- Known clinically relevant maternal or fetal abnormality (e.g., as determined by ultrasound or genetic testing), such as placenta previa,
- History of anaphylactic or severe systemic reaction to immunoglobulin of any origin,
- Current diagnosis of an immune disease which by itself or its treatment could impair the safety and/or efficacy evaluation of Roledumab in this study. These diseases are: All immune deficiencies, particularly those requiring IV-Ig supplementation or other systemic treatment / connective tissue and autoimmune diseases (e.g., systemic lupus erythematosus, antiphospholipid syndrome, Sjögren's syndrome, rheumatoid arthritis, ankylosing spondylarthritis) requiring systemic immunosuppressive treatment / allergic and inflammatory diseases requiring systemic immunosuppressive treatment,
- Clinically significant medical history contraindicating the participation in the study according to the judgment of the Investigator or Sponsor,
- Clinically significant laboratory (hematology, blood chemistry, or urinalysis) parameters,
- For the IM arm only, subject with coagulation disorders contraindicating intramuscular injection (patient will still be considered for the IV arm),
- Transfusion of RhD-positive blood or blood derived products within the 6 months prior to enrolment,
- Anticipated poor compliance with the study procedures,
- Subject within exclusion period further to her participation in a clinical study.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2017
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02287896
Start Date
April 1 2014
End Date
September 13 2017
Last Update
July 13 2020
Active Locations (8)
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1
Jeanne de Flandre Hospital
Lille, France, 59037
2
Croix-Rousse Maternity
Lyon, France, 69317
3
University Hospital Center
Nantes, France, 44093
4
Armand-Trousseau Hospital
Paris, France, 75012