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OpenTrials
Completed

NCT Number: NCT02247154

A Study of the Safety and Efficacy of 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.

Completed

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Key information

Conditions

Primary or Secondary Antibody Deficiency

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

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

  • 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

-

Treatment and study plan

Vigam® (Human Normal Immunoglobulin)

Biological

Primary outcomes

  1. IgG half-life

    Time frame: Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose

Sponsors and collaborators

Lead sponsor

Bio Products Laboratory

Other

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2001
First posted
Sep 23, 2014
Registry last updated
Feb 15, 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.