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Pharmacokinetics and Safety of Roledumab in RhD-negative Pregnant Women Carrying an RhD-positive Foetus

NCT02287896 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-07-13

Study results available
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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.

Conditions

  • Rh Disease

Interventions

DRUG

ROLEDUMAB

See Arm description

Sponsors & Collaborators

  • Laboratoire français de Fractionnement et de Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Norbert WINER, MD · Nantes University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-09-13
Completion
2017-09-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02287896 on ClinicalTrials.gov