A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency

February 14, 2018 updated by: Bio Products Laboratory

A Study of the Safety and Efficacy of an Intravenous Immunoglobulin (Vigam® Liquid) in Patients With Primary or Secondary Antibody Deficiency.

To determine:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cardiff, United Kingdom
        • Cardiff Royal Infirmary
      • Leicester, United Kingdom
        • Leicester Royal Infirmary
      • London, United Kingdom
        • Royal Brompton Hospital
      • London, United Kingdom
        • Royal Free Hospital
      • Newcastle, United Kingdom
        • Royal Victoria Infirmary
      • Rugby, United Kingdom
        • Hospital of St Cross
      • Somerset, United Kingdom
        • Taunton & Somerset Hospital
    • Cambridgeshire
      • Papworth Everard, Cambridgeshire, United Kingdom
        • Papworth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vigam® Liquid
Biological: Vigam® (Human Normal Immunoglobulin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IgG half-life
Time Frame: Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose
Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio Products Laboratory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Primary Completion (Actual)

July 1, 2001

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 23, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIGPSAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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