NCT02246855

Brief Summary

The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).

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

August 1, 2004

Completed
4 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 2, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
Last Updated

February 27, 2018

Status Verified

August 1, 2014

Enrollment Period

4 months

First QC Date

September 2, 2014

Last Update Submit

February 26, 2018

Conditions

Healthy

Keywords

Subjects

Outcome Measures

Primary Outcomes (1)

  • PK parameters for serum immunoglobulin G (IgG)

    Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85

Study Arms (3)

Vigam® Liquid infused at up to 3mL/min

EXPERIMENTAL

Gammaplex® (Human Normal Immunoglobulin)

Biological: Gammaplex® (Human Normal Immunoglobulin)

Gammaplex® infused at up to 3mL/min

EXPERIMENTAL

Gammaplex® (Human Normal Immunoglobulin)

Biological: Gammaplex® (Human Normal Immunoglobulin)

Gammaplex® infused at up to 6mL/min

EXPERIMENTAL

Gammaplex® (Human Normal Immunoglobulin)

Biological: Gammaplex® (Human Normal Immunoglobulin)

Interventions

Gammaplex® (Human Normal Immunoglobulin)BIOLOGICAL
Gammaplex® infused at up to 3mL/minGammaplex® infused at up to 6mL/minVigam® Liquid infused at up to 3mL/min

Eligibility Criteria

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

You may not qualify if:

  • Female volunteers of childbearing potential had a negative pregnancy test before entering the study and had to use either a double barrier method of contraception or use the oral contraceptive pill.
  • Postmenopausal or surgically sterile female volunteers could be enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology Research Unit (CPRU)

Level 7, Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Interventions

gamma-Globulins

Intervention Hierarchy (Ancestors)

ImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • David Wessels, MBChB MBA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 23, 2014

Study Start

August 1, 2004

Primary Completion

December 1, 2004

Last Updated

February 27, 2018

Record last verified: 2014-08

Locations

GB(1)