NCT02246842

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

September 15, 2014

Last Update Submit

March 12, 2018

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guildford Clinical Pharmacology Unit

Unit 34, Surrey Technology Centre, Surrey Research Park, Occam Road, Guildford, Surrey, GU2 7YG, United Kingdom

Location

Related Links

MeSH Terms

Interventions

Rho(D) Immune Globulin

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Dr A Sutton, MB BS, FFARCSI

    Guildford Clinical Pharmacology Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 23, 2014

Study Start

May 1, 2004

Primary Completion

December 1, 2004

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations

GB(1)