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NCT Number: NCT00405184

Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)

This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P. Eligible patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly intervals. Patients will be monitored on the study for up to 36 weeks.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Flinders Medical Centre, Adelaide, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of PID
  • = or >6 month use of Intragam P at three- or four-weekly intervals
  • = or >6 month history of IgG trough levels of ≥ 5 g/L

Exclusion criteria

  • Newly diagnosed PID within six months prior to Screening
  • Known selective IgA deficiency or antibodies to IgA
  • Immunosuppressive treatment other than topical and/ or inhaled steroids and/ or low dose oral steroids
  • Protein-losing enteropathies, or kidney diseases
  • History of malignancies of lymphoid cells
  • Any of the following laboratory results at Screening:
  • Serum Creatinine > 1.5 times the upper normal limit (UNL)
  • AST or ALT concentration > 2.5 times the UNL
  • Albumin < 25 g/L

Treatment and study plan

IntragamP

Drug

IntragamP - dosage based on previous dose of IntragamP prior to study entry. One cycle (Cycle 0)only administered, with dosage calculation based on body weight on Day 1 of the study and must be between 0.2-0.8 g/kg body weight. IntragamP to be administered intravenously.

Ig NextGen 10%

Drug

Ig NextGen 10% - dosage based on previous dose of IntragamP in Cycle 0. Dosage calculation to use body weight on Day 1 of Cycle 1 of the study and must be between 0.2-0.8 g/kg body weight. 7 cycles administered, and patients to be dosed at 3 to 4 week intervals (in accordance with previous dosage schedule with IntragamP). Ig NextGen 10% to be administered intravenously.

Primary outcomes

  1. IgG Trough Pharmacokinetics

    Time frame: one month

Secondary outcomes

  1. Safety and tolerability, Pharmacokinetics

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

CSL Limited

Industry

Registry information

Official study title

A Multi-centre, Open-label, Cross-over Study to Compare the Pharmacokinetics, Safety and Tolerability of Ig NextGen 10% With Intragam P in Patients With Primary Immune Deficiency (PID)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 29, 2006
Registry last updated
Jun 7, 2012

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.

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