Status:

COMPLETED

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

Lead Sponsor:

Bio Products Laboratory

Conditions:

Primary Antibody Deficiency

Eligibility:

All Genders

Phase:

PHASE3

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 object...

Eligibility Criteria

Inclusion

  • 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

  • \-

Key Trial Info

Start Date :

June 1 2000

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT02247141

Start Date

June 1 2000

Last Update

January 24 2018

Active Locations (14)

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Page 1 of 4 (14 locations)

1

Papworth Hospital

Papworth Everard, Cambridgeshire, United Kingdom

2

Royal Preston Hospital

Preston, Lancashire, United Kingdom

3

Guest Hospital

Dudley, West Midlands, United Kingdom

4

Birmingham Children's Hospital

Birmingham, United Kingdom

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