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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247141
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Primary Antibody Deficiency Biological: Subgam® (Human Normal Immunoglobulin Solution) Phase 3

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Study Type : Interventional  (Clinical Trial)
Official Title: A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam® Given Via the Subcutaneous Route in Primary Antibody Deficient Patients.
Study Start Date : June 2000
Actual Primary Completion Date : January 2005


Arm Intervention/treatment
Experimental: Subgam® Biological: Subgam® (Human Normal Immunoglobulin Solution)



Primary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247141


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT02247141    
Other Study ID Numbers: SCIG01
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Common Variable Immunodeficiency
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs