A Phase II, open-label, randomised, dose-finding study to compare the efficacy (in terms of clearance of RhD-positive RBCs) and safety of LFB-R593, a monoclonal anti-RhD antibody, vs Rhophylac®, a polyclonal anti-RhD immunoglobulin in healthy RhD negative volunteers

• Conditions: Prophyllaxis against RhD isoimmunisation during pregnancy (anti-D prophylaxis)Treatment of RhD negative individuals after incompatible transfusions with blood components containing RhD-positive red blood cells.; MedDRA version: 9.1Level: LLTClassification code 10019513Term: Hemolytic disease of fetus or newborn, due to isoimmunization; MedDRA version: 9.1Level: LLTClassification code 10044360Term: Transfusion with incompatible blood

• Registration Number: EUCTR2009-011017-24-DE
• Lead Sponsor: FB Biotechnologies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Healthy Rh(D) negative volunteers with positive tests for blood group antigens
Cellano (Kell) and Lu(b)
- No prior sensitisation to Rh(D) as measured by a negative test for anti-D
antibodies (Indirect Coombs test)
- Males and definitively sterile females (post-menopausal since at least 1 year
confirmed by FSH >40 U/l or hysterectomised women)
- Age from 18 to 60 years
- Signed and dated informed consent form prior to proceeding with any
study-related procedure

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Rh(D) positive, including Rh(D)weak positive healthy volunteers.
- Detection of antibodies against any erythrocyte antigen in antibody screening
(RBC irregular antibody screening using indirect Coombs test)
- Known history of hypersensitivity to any drugs, and of relevant/clinically
significant allergic reactions of any origin
- Known history of anaphylactic or severe systemic reaction to globulin of any origin.
- Known history of immune disorders
- Hepatic, renal, endocrine or metabolic disorders
- Subjects with clinically significant changes in laboratory values
- Concomitant drug treatment (except paracetamol) within 28 days prior to the
study entry.
- Therapy with an immuno-stimulating or –suppressive drug or any other therapy
influencing the immune system including vaccinations, in the last 3 months prior to
study entry.
- Previous administration of monoclonal or polyclonal antibody within the past year.
- Treatment with any investigational product or participation in another clinical study
within 30 days prior to the screening visit or within a time period of 5 half-lives of
the previous investigational product, which ever is longer.
- Subjects with abnormalities in physical examination or vital signs or laboratory
results or 12-lead ECG that, in the opinion of the Investigator, are deemed to be
clinically significant.
- Vulnerable subjects (e.g. persons kept in detention)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified