Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT00405184
First received: November 27, 2006
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Primary Immune Deficiency (PID)
Drug: IntragamP
Drug: Ig NextGen 10%
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • IgG Trough Pharmacokinetics [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability, Pharmacokinetics [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: May 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: IntragamP
    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.
    Drug: Ig NextGen 10%
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405184

Locations
Australia, South Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
Sponsors and Collaborators
CSL Limited
Investigators
Principal Investigator: Karl Bleasel, Dr Melbourne Health
  More Information

Publications:
Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT00405184     History of Changes
Other Study ID Numbers: CSLCT-PID-05-22
Study First Received: November 27, 2006
Last Updated: June 5, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by CSL Limited:
PID
IVIg
IntragamP

ClinicalTrials.gov processed this record on November 20, 2014