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High Infusion Speed Study (NGAM-05)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01313507
First received: March 9, 2011
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Primary Immunodeficiency Syndrome
 Biological: NewGam
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Octapharma:

Primary Outcome Measures:
  • 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    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.


Enrollment: 21
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NewGam IV infusion Biological: NewGam
NewGam IV infusion

  Eligibility

Ages Eligible for Study:   2 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313507

Locations
United States, California
University of California Irvine
Irvine, California, United States
United States, Colorado
Immunoe Research Center
Centennial, Colorado, United States
United States, Illinois
Rush Universtity Medical Center
Chicago, Illinois, United States
United States, Missouri
Cardinal Glennon Children's Hospital
St. Louis, Missouri, United States
United States, Nebraska
Midlands Pediatrics
Papillion, Nebraska, United States
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States
Sponsors and Collaborators
Octapharma
  More Information

No publications provided

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01313507     History of Changes
Other Study ID Numbers: NGAM-05
Study First Received: March 9, 2011
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Octapharma:
Primary Immunodeficiency Syndrome
PID

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013