High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam) (NGAM-05)

Octapharma

Status and phase

Completed

Phase 3

Conditions

Primary Immunodeficiency Disease

Treatments

Biological: NewGam

Study type

Interventional

Funder types

Industry

Identifiers

NCT01313507

NGAM-05

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

2 to 75 years old

Volunteers

No Healthy Volunteers

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.