Subcutaneous Ig NextGen 16% in PID Patients

NCT ID: NCT00391131

Last Updated: 2012-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-10-31

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ig NextGen 16%

Group Type: EXPERIMENTAL

IgNextGen 16%

Intervention Type: DRUG

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

Interventions

IgNextGen 16%

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• • 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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne Empson, Dr

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Locations

The Canberra Hospital

Garran, Australian Capital Territory, Australia

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Sydney Children's Hospital

Randwick, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Women's & Children's Hospital

North Adelaide, South Australia, Australia

Frankston Hospital

Frankston, Victoria, Australia

Royal Children's Hospital

Melbourne, Victoria, Australia

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Auckland Hospital

Auckland, , New Zealand

Starship Children's Hospital

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Wellington Hospital

Wellington, , New Zealand

Countries

Australia; New Zealand

References

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.

Reference Type: RESULT

PMID: 22526590 (View on PubMed)

Other Identifiers

CSLCT-SCIG-05-23

Identifier Type: -

Identifier Source: org_study_id