Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)

PHASE3CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions
Primary Immune Deficiency (PID)
Interventions
DRUG

IntragamP

IntragamP - dosage based on previous dose of IntragamP prior to study entry. One cycle (Cycle 0)only administered, with dosage calculation based on body weight on Day 1 of the study and must be between 0.2-0.8 g/kg body weight. IntragamP to be administered intravenously.

DRUG

Ig NextGen 10%

Ig NextGen 10% - dosage based on previous dose of IntragamP in Cycle 0. Dosage calculation to use body weight on Day 1 of Cycle 1 of the study and must be between 0.2-0.8 g/kg body weight. 7 cycles administered, and patients to be dosed at 3 to 4 week intervals (in accordance with previous dosage schedule with IntragamP). Ig NextGen 10% to be administered intravenously.

Trial Locations (4)

Unknown

Flinders Medical Centre, Adelaide

Royal Adelaide Hospital, Adelaide

The Alfred Hospital, Melbourne

The Royal Melbourne Hospital, Melbourne

All Listed Sponsors
lead

CSL Limited

INDUSTRY

NCT00405184 - Ig NextGen 10% in Patients With Primary Immune Deficiency (PID) | Biotech Hunter | Biotech Hunter