High Infusion Speed Study

Primary Immunodeficiency Syndrome Clinical Trial

— NGAM-05  

Official title:

CLINICAL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) ADMINISTERED AT HIGH INFUSION RATES TO PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES (EXTENSION OF STUDY NGAM 01)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313507
• Other study ID #: NGAM-05
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2011
• Last updated: October 9, 2012
• Start date: March 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a prospective, open-label, non-controlled, non-randomised multicentre Phase III study of two multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study) for three months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 75 Years

Eligibility

Inclusion Criteria:

• Completion of the main study NGAM 01,

• At each of the last three infusions in the main study NGAM 01, administration of NewGam at the maximum infusion rate of 0.08 mL/kg/min and without the need for premedication,

Exclusion Criteria:

• Any condition or circumstance that would have led to the exclusion of the subject from the NGAM 01 study,

• Administration of any immunoglobulin infusion other than NewGam between conclusion of the NGAM 01 study and the beginning of the present study,

• A deviation of the subject's treatment interval of more than 7 days between the last infusion of NewGam in the NGAM 01 study and the first infusion of NewGam in the present study.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immunodeficiency Syndrome

Intervention

Biological:
• NewGam
NewGam IV infusion

Locations

Country	Name	City	State
United States	Immunoe Research Center	Centennial	Colorado
United States	Rush Universtity Medical Center	Chicago	Illinois
United States	University of California Irvine	Irvine	California
United States	Midlands Pediatrics	Papillion	Nebraska
United States	Seattle Children's Hospital	Seattle	Washington
United States	Cardinal Glennon Children's Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of NewGam when administered at infusion rates from 0.08 mL/kg/min (the maximum rate in study NGAM-01) to 0.14 mL/kg/min.	Efficacy: IgG trough levels are to be recorded, as they are required for dosing.; Safety: Occurrence of AEs.; Proportion of infusions with 1 or more temporally associated AEs.; Short term tolerance parameters including vital signs.; Laboratory parameters. Quality of life.	18 months	No