The study duration for individual patients will be up to 55 weeks for the 4-weekly and 3- weekly schedule of the treatment which includes 3 weeks for screening, 48 weeks for Study Medication administration and 4 weeks for follow-up assessments
Eligible subjects will receive either test or reference as per the randomization in 1:1 ratio. Test group: V-Immune will be administered at 200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose. Reference group: Immuglo will be administered at 200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
V-Immune will be administered at 200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose
Immuglo will be administered at 200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose
All India Institute of Medical Sciences
Nagpur, Maharashtra, India
Jyoti Nursing Home (P) Ltd.
Jaipur, Rajasthan, India
Primary - Incidence of acute serious bacterial infections
incidence of acute serious bacterial infections per patient will be assessed at 52 weeks
Time frame: 52 weeks
Secondary - Pharmacokinetics
To assess the Ig serum concentration - Cmax
Time frame: 52 weeks
Secondary Pharmacokinetics
To assess the IgG serum concentration Tmax
Time frame: 52 weeks
Safety of IVIG
Safety will be assessed
Time frame: 52 weeks
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