NCT00168012

Brief Summary

The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency. As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

February 11, 2011

Status Verified

February 1, 2011

First QC Date

September 12, 2005

Last Update Submit

February 10, 2011

Conditions

AgammaglobulinemiaIgG DeficiencyCommon Variable Immunodeficiency

Keywords

Immunoglobulin intravenousAgammaglobulinemiaHypogammaglobulinemiaCommon variable immunodeficiencyImmunoglobulin GChildren

Outcome Measures

Primary Outcomes (1)

  • Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.

Secondary Outcomes (4)

  • Rate of acute serious bacterial infections

  • Number of days out of work/school due to underlying PID

  • Number of infections

  • Rate, severity and relationship of all adverse events

Interventions

Immunoglobulins Intravenous (Human)DRUG

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary immunodeficiency
  • Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10

You may not qualify if:

  • Allergic reactions to immunoglobulins or other blood products
  • Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day
  • History of cardiac insufficiency
  • Epilepsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Berger M, Cunningham-Rundles C, Bonilla FA, Melamed I, Bichler J, Zenker O, Ballow M. Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. J Clin Immunol. 2007 Sep;27(5):503-9. doi: 10.1007/s10875-007-9096-9. Epub 2007 May 4.

    PMID: 17479360RESULT

MeSH Terms

Conditions

AgammaglobulinemiaIgG DeficiencyCommon Variable Immunodeficiency

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Blood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDysgammaglobulinemia

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

September 1, 2004

Study Completion

September 1, 2005

Last Updated

February 11, 2011

Record last verified: 2011-02