HealthyPhase 2NCT00952575
Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers
A Phase 2 study testing polyclonal anti-D immunoglobulin and monoclonal anti-D immunoglobulin in people with Healthy, run by Laboratoire français de Fractionnement et de Biotechnologies at 1 site in Germany.
Trial summary
This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing RhD-alloimmunisation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- polyclonal anti-D immunoglobulin and monoclonal anti-D immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy RhD-negative volunteers
- Males and definitively sterile females
- No prior sensitization to RhD antigen
Who cannot join
- Healthy RhD-positive volunteers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 a Polyclonal Anti-RhD Immunoglobulin in Healthy RhD Negative Volunteers
This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing RhD-alloimmunisation.
- Conditions
- Healthy
- Being tested
- polyclonal anti-D immunoglobulin, monoclonal anti-D immunoglobulin
- Keywords
- Prevention of foeto-maternal allo-immunisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyclonal anti-D immunoglobulinDrug
single injection of 300 µg
monoclonal anti-D immunoglobulinDrug
Comparison of different dosages of LFB-R593
| Study group | Role | What they receive |
|---|---|---|
| polyclonal anti-D immunoglobulin | Active comparator | Not described Receives: Drug: polyclonal anti-D immunoglobulin |
| Monoclonal anti-D immunoglobulin | Experimental | Not described Receives: Drug: monoclonal anti-D immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of RhD-positive red blood cells
Measured: within 2 weeks after RBC injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Thomas Kornicke, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952575
- Sponsor's protocol ID
- ADNC-0726
- Status last verified
- Sep 2011
- First submitted
- 3 Aug 2009
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 a Polyclonal Anti-RhD Immunoglobulin in Healthy RhD Negative Volunteers
- ClinicalTrials.gov ID
- NCT00952575
- Acronym / sponsor ID
- ADNC-0726
- Conditions
- Healthy
- Keywords
- Prevention of foeto-maternal allo-immunisation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Laboratoire français de Fractionnement et de BiotechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing RhD-alloimmunisation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyclonal anti-D immunoglobulin | Active comparator | Drug: polyclonal anti-D immunoglobulin |
| Monoclonal anti-D immunoglobulin | Experimental | Drug: monoclonal anti-D immunoglobulin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy RhD-negative volunteers
- Males and definitively sterile females
- No prior sensitization to RhD antigen
Key exclusion criteria (1 listed)
- Healthy RhD-positive volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyclonal anti-D immunoglobulinsingle injection of 300 µg | Drug | polyclonal anti-D immunoglobulin |
| monoclonal anti-D immunoglobulinComparison of different dosages of LFB-R593 | Drug | Monoclonal anti-D immunoglobulin |
Primary outcome
Clearance of RhD-positive red blood cells
Time frame: within 2 weeks after RBC injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kornicke principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing polyclonal anti-D immunoglobulin and monoclonal anti-D immunoglobulin in people with Healthy, run by Laboratoire français de Fractionnement et de Biotechnologies at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of RhD-positive red blood cells (time frame: within 2 weeks after RBC injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2011; AzTrials last refreshed its copy on 6 Nov 2026.