A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®

January 23, 2018 updated by: Bio Products Laboratory

A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam® Given Via the Subcutaneous Route in Primary Antibody Deficient Patients.

The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®) given subcutaneously by weekly infusion to patients with primary antibody deficiency.

The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly infusion to patients with primary antibody deficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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
      • Birmingham, United Kingdom
        • Birmingham Children's Hospital
      • Cardiff, United Kingdom
        • University Hospital of Wales
      • Leeds, United Kingdom
        • St James' University Hospital
      • Leicester, United Kingdom
        • Leicester Royal Infirmary
      • London, United Kingdom
        • Great Ormond Street Hospital
      • London, United Kingdom
        • St Bartholomew's Hospital
      • Oxford, United Kingdom
        • John Radcliffe Hospital
      • Salford, United Kingdom
        • Hope Hospital
      • Sheffield, United Kingdom
        • Northern General Hospital
      • Southampton, United Kingdom
        • Southampton General Hospital
      • Surrey, United Kingdom
        • St Helier Hospital, Carshalton
    • Cambridgeshire
      • Papworth Everard, Cambridgeshire, United Kingdom
        • Papworth Hospital
    • Lancashire
      • Preston, Lancashire, United Kingdom
        • Royal Preston Hospital
    • West Midlands
      • Dudley, West Midlands, United Kingdom
        • Guest 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The main criteria for inclusion in the study were as follows:

    • A diagnosis of primary antibody deficiency;
    • No lower or upper age limit (any age was eligible);
    • With stable disease and receiving immunoglobulin (IVIG or SCIG) therapy for at least six months prior to starting the study;
    • Written informed consent (patient/parent/guardian).

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?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subgam®
Biological: Subgam® (Human Normal Immunoglobulin Solution)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L
Time Frame: Before each infusion in the first 6 months of the study (approximately 30 infusions)
Before each infusion in the first 6 months of the study (approximately 30 infusions)

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.

General Publications

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

June 1, 2000

Primary Completion (Actual)

January 1, 2005

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)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCIG01

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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