NCT02247154

Brief Summary

To determine:

  1. 1.The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency (PAD or SAD).
  2. 2.The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.
  3. 3.The half-life of Vigam® Liquid after 4 months of treatment.
  4. 4.The subclass and total gammaglobulin concentrations after each infusion of Vigam® Liquid.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

8 active sites

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

April 1, 1999

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
13.2 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 15, 2018

Status Verified

February 1, 2018

Enrollment Period

2.3 years

First QC Date

September 2, 2014

Last Update Submit

February 14, 2018

Conditions

Primary or Secondary Antibody Deficiency

Outcome Measures

Primary Outcomes (1)

  • IgG half-life

    Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose

Study Arms (1)

Vigam® Liquid

EXPERIMENTAL
Biological: Vigam® (Human Normal Immunoglobulin)

Interventions

Vigam® (Human Normal Immunoglobulin)BIOLOGICAL
Vigam® Liquid

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18-80 years) with PAD or SAD
  • With a low serum IgG (\<6 g/l) and a history of recurrent infections
  • Requiring and eligible for polyvalent intravenous immunoglobulin (IVIG) replacement therapy
  • Non-reactive for HBsAg and with an alanine aminotransferase (ALT) level less than twice upper limit of normal prior to entry into the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Papworth Hospital

Papworth Everard, Cambridgeshire, United Kingdom

Location

Cardiff Royal Infirmary

Cardiff, United Kingdom

Location

Leicester Royal Infirmary

Leicester, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

Royal Victoria Infirmary

Newcastle, United Kingdom

Location

Hospital of St Cross

Rugby, United Kingdom

Location

Taunton & Somerset Hospital

Somerset, United Kingdom

Location

Related Links

MeSH Terms

Interventions

gamma-Globulins

Intervention Hierarchy (Ancestors)

ImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 23, 2014

Study Start

April 1, 1999

Primary Completion

July 1, 2001

Last Updated

February 15, 2018

Record last verified: 2018-02

Locations

GB(8)