Skip to main content
OpenTrials
Completed

NCT Number: NCT02247141

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Antibody Deficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Papworth Hospital, Papworth Everard, Cambridgeshire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Subgam® (Human Normal Immunoglobulin Solution)

Biological

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bio Products Laboratory

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2005
First posted
Sep 23, 2014
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.