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

March 9, 2011
October 9, 2012
March 2011
September 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01313507 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
High Infusion Speed Study
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Immunodeficiency Syndrome
Biological: NewGam
NewGam IV infusion
Experimental: NewGam IV infusion
Intervention: Biological: NewGam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
2 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01313507
NGAM-05
Yes
Octapharma
Octapharma
Not Provided
Not Provided
Octapharma
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP