Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Ant... | NCT00952575

Studies
Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers

NCT00952575

Sponsor

Laboratoire français de Fractionnement et de Biotechnologies

Status

Completed

Last Update Posted

Sep 13, 2011Estimated

Enrollment

78Actual

Phase

Phase 2

Conditions

Healthy

Interventions

polyclonal anti-D immunoglobulin
monoclonal anti-D immunoglobulin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Aug 3, 2009

First Submission Date that Met QC Criteria

Aug 4, 2009

First Posted Date

Aug 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2011

Last Update Posted Date

Sep 13, 2011Estimated

Name	Class
Parexel	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
polyclonal anti-D immunoglobulin	Active Comparator		Drug: polyclonal anti-D immunoglobulin
Monoclonal anti-D immunoglobulin	Experimental		Drug: monoclonal anti-D immunoglobulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
polyclonal anti-D immunoglobulin	Drug	single injection of 300 µg	polyclonal anti-D immunoglobulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clearance of RhD-positive red blood cells		within 2 weeks after RBC injection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy RhD-negative volunteers
Males and definitively sterile females
No prior sensitization to RhD antigen

Exclusion Criteria:

Healthy RhD-positive volunteers

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Kornicke	Parexel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parexel Early Phase Clinical Unit		Berlin		14050	Germany