Phase 2
Completed N=62
Pharmacokinetics and Safety of Roledumab in RhD-negative Pregnant Women Carrying an RhD-positive Foetus
Rh Disease
Source: ClinicalTrials.gov NCT02287896 ↗
Enrolled (actual)
62
Serious AEs
38.7%
Results posted
Aug 2019
Primary outcomePrimary: CL/F : Apparent Clearance — 0.0106 L/h
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-negative pregnant women and in RhD-positive fetus and newborns.
In addition the efficacy of Roledumab 300μg IM and IV to prevent RhD alloimmunisation in RhD-negative pregnant women carrying an RhD-positive fetus and the immunogenicity of Roledumab will be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CL/F : Apparent Clearance |
0.0106 | — |
| PRIMARY V2/F : Central Volume of Distribution |
4.02 | — |
| PRIMARY t 1/2 : Terminal Half-life |
481.7 | — |
| PRIMARY C Max |
21.6; 71.8 | — |
| PRIMARY T Max |
167.21; 1.00 | — |
| PRIMARY T 1/2 |
462; 412 | — |
| PRIMARY AUC 0-t |
16600; 24900 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02287896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.