Subcutaneous Ig NextGen 16% in PID Patients

NCT00391131 | Completed Phase 3

• 1 other identifier: CSLCT-SCIG-05-23
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 12

Brief Summary

This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig NextGen 16% in people with antibody deficiency currently being treated with IntragamP. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation manufactured using predominately chromatographic techniques. Eligible patients will switch from monthly intravenous IntragamP therapy to weekly subcutaneous Ig NextGen 16% treatment. Initial hospital training will be required for subcutaneous administration and then the patient will perform the infusion in their own home, returning once a month for a supervised infusion. Patients will be monitored on the study for up to 10 months to assess blood IgG levels and rate of serious bacterial infections.

Conditions

Primary Immunodeficiency (PID)

Keywords

PID; SCIG; Ig; Quality of Life; Serious Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Continually from Visits 7 to 12 & monthly IgG troughs

Secondary Outcomes (1)

• Safety, Tolerability, Quality of Life, Pharmacokinetics

  Visits 0, 6, 9, and12

Study Arms (1)

Ig NextGen 16%

EXPERIMENTAL

Drug: IgNextGen 16%

Interventions

IgNextGen 16% DRUG

IgNextGen 16% administered subcutaneously on a weekly basis from visit 1 to 12

Ig NextGen 16%

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females 3 years of age or greater and at least 13 kg at enrolment.
• PID patients receiving Ig replacement therapy, with a diagnosis of X-linked agammaglobulinemia (XLA) or Common Variable immunodeficiency (CVID) with severe hypogammaglobulinemia.
• Patients who have received a consistent dose of Intragam®P at 3-, 4-, 5- or 6-weekly intervals, within the range of 0.2 - 0.6 g/kg body weight, for at least six months prior to the Screening visit.
• Patients must have maintained IgG trough serum level of ≥ 5 g/L during the six months prior to Visit 0, with at least two trough levels to have been documented during this period.
• Patients and/or their legally acceptable representative/guardian must give written informed consent to participate in the study and must understand the nature of the study and must be willing to comply with all protocol requirements

You may not qualify if:

• Patients newly diagnosed with PID within six months of the Screening visit.
• Patients with known or suspected severe hypersensitivity or previous evidence of severe side effects to immunoglobulin therapy or other blood products
• Patients with known selective IgA deficiency or antibodies to IgA
• Patients receiving immunosuppressive treatment other than topical and/or inhaled steroids and low dose oral steroids.
• Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Females who are of child bearing potential must have a negative pregnancy test at screening.
• Patients with protein-losing enteropathies, and kidney diseases with substantial proteinuria
• Patients with malignancies of lymphoid cells such as chronic lymphocytic leukaemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma.
• Patients who have within 30 days priors to the study screening visit, participated in a clinical study or used an investigational compound (eg: a new chemical entity not registered for clinical use).
• Patients with any of the following abnormal lab results:
• Serum creatinine \>1.5 x Upper limit of Normal (ULN).
• Serum ALT \& AST \> 2.5 x ULN.
• Albumin \< 25 g/L
• Patients who are suffering from an acute or chronic medical condition, other than PID, which may, in the opinion of the Investigator, affect the conduct of the trial.
• Patients who are not willing or are unable to comply with protocol.

Sponsors & Collaborators

• CSL Limited: lead

Study Sites (12)

The Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Women's & Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

Frankston Hospital

Frankston, Victoria, Australia

Location

Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Location

Auckland Hospital

Auckland, New Zealand

Location

Starship Children's Hospital

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Wellington Hospital

Wellington, New Zealand

Location

Related Publications (1)

• Empson MB, Tang ML, Pearce LK, Rozen L, Gold MS, Katelaris CH, Langton D, Smart J, Smith WB, Steele RH, Ziegler JB, Maher D. Efficacy, safety and pharmacokinetics of a novel subcutaneous immunoglobulin, Evogam(R), in primary immunodeficiency. J Clin Immunol. 2012 Oct;32(5):897-906. doi: 10.1007/s10875-011-9641-4. Epub 2012 Apr 13.

  PMID: 22526590 RESULT

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Marianne Empson, Dr

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 23, 2006
• Study Start: April 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 7, 2012

Record last verified: 2012-06

Locations

NZ (4); AU (8)