Clinical trial NCT01313507: High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Immunodeficiency Disease
Keywords: Primary Immunodeficiency Disease
PID
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 21
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study NCT01012323 \[NGAM-01\]) for 3 months. The primary objective of the study was to assess the safety and tolerability of high infusion rates of NewGam.

Detailed description: Patients received NewGam via an infusion pump to control precise infusion rates. All NewGam infusions started at a rate of 0.01 mL/kg/min (60 mg/kg/h) for the first 30 minutes followed by 0.03 mL/kg/min (180 mg/kg/h) for the next 15 minutes. If tolerated, further increments were made at predefined patterns with the following maximum rates: 0.10 mL/kg/min (600 mg/kg/h) in the first infusion; if this was tolerated, 0.12 mL/kg/min (720 mg/kg/h) in the second infusion; if this was tolerated, 0.14 mL/kg/min (840 mg/kg/h) in all subsequent infusions.

If an adverse event occurred during an infusion, the rate was reduced to half the rate at which the event occurred or the infusion was interrupted until symptoms subsided. The infusion was then resumed at a rate tolerated by the patient.

Eligibility criteria: Inclusion Criteria:

* Completion of the main study NGAM-01.
* At each of the last 3 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.

Primary outcomes:
measure: Percentage of Participants Who Experienced at Least 1 Adverse Event Causally Related to the Administration of the Study Drug
timeFrame: Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)
measure: Percentage of Participants Who Experienced at Least 1 Adverse Event Temporally Related to the Study Drug
timeFrame: Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)
Secondary outcomes:
measure: Change From Baseline in the Quality of Life (QoL) at the End of the Study
timeFrame: Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Centennial
country: United States
facility: Immunoe Research Center
state: Colorado
city: Chicago
country: United States
facility: Rush Universtity Medical Center
state: Illinois
city: St. Louis
country: United States
facility: Cardinal Glennon Children's Hospital
state: Missouri
city: Papillion
country: United States
facility: Midlands Pediatrics
state: Nebraska
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Rush Medical Center
name: James N Moy, MD
role: PRINCIPAL_INVESTIGATOR
References: