A Study Comparing the Pharmacokinetics and Tolerance of D... | NCT02246842

Studies
A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers.

NCT02246842

Sponsor

Bio Products Laboratory

Status

Completed

Last Update Posted

Mar 14, 2018Actual

Enrollment

Not provided

Phase

Phase 1

Conditions

Healthy

Interventions

D-Gam® (human anti-D immunoglobulin)
Rhophylac® (human anti-D immunoglobulin)

Countries

United Kingdom

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

Mar 2018

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

May 2004

Primary Completion Date

Dec 2004Actual

Completion Date

Not provided

First Submitted Date

Sep 15, 2014

First Submission Date that Met QC Criteria

Sep 19, 2014

First Posted Date

Sep 23, 2014Estimated

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

Mar 12, 2018

Last Update Posted Date

Mar 14, 2018Actual

Description Module

Brief Summary

The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.

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 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
D-Gam®	Experimental	D-Gam® (human anti-D immunoglobulin)	Biological: D-Gam® (human anti-D immunoglobulin)
Rhophylac®	Active Comparator	Human Anti-D Immunoglobulin	Biological: Rhophylac® (human anti-D immunoglobulin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
D-Gam® (human anti-D immunoglobulin)	Biological		D-Gam®
Rhophylac® (human anti-D immunoglobulin)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax for anti-D		Pre-dose, 1, 8, 24, 32, 48, 72 & 96 hours; 1, 2, 3, 4, 5, 6, 8, 10, 12 & 14 weeks post-dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females
Ages of 18 and 55 years
Bodyweight of 50-85kg.

Exclusion Criteria:

Clinically relevant abnormalities at physical examination, ECG or laboratory tests.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr A Sutton, MB BS, FFARCSI	Guildford Clinical Pharmacology Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guildford Clinical Pharmacology Unit		Unit 34, Surrey Technology Centre, Surrey Research Park	Occam Road, Guildford, Surrey	GU2 7YG	United Kingdom

Label	URL
Sponsor's Homepage	View source

Intervention Browse Module

MeSH Terms

ID	Term
D018029	Rho(D) Immune Globulin

Ancestor Terms

ID	Term
D007074	Immunoglobulin G
D007132	Immunoglobulin Isotypes
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided