Health Condition 1: D849- Immunodeficiency, unspecified
Conditions
Interventions
Intervention1: Human Normal Immunoglobulin (IVIG) for Intravenous use: Recommended starting dose of 400-800 mg per kg per infusion, followed by 200-800
mg per kg per infusion every 21 or 28 days, intr
Sponsors
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with a confirmed clinical diagnosis of a PID 2. Has received 200-800 mg/kg of licensed IVIG therapy at 21 or 28 days intervals for 3 months 3. 2 documented IgG trough levels of more than equal to 5 g per L are obtained at 2 infusion cycles 4. Subject is willing to comply with all requirements of the protocol 5. Females of child-bearing potential with a negative urine pregnancy test
Exclusion criteria
Exclusion criteria: 1. Has secondary immunodeficiency 2. Newly diagnosed and has not been treated with immunoglobulin history of repeated reactions or hypersensitivity to IVIG 3. Has received blood products 4. Has an acute infection 5. Has profound anemia 6. Severe chronic condition such as renal failure, etc 7. Has a history of a malignant disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| measures the incidence of acute serious bacterial infectionsTimepoint: End of study 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Unable to perform normal daily activitiesTimepoint: End of study 12 months;Unscheduled physician/clinic visitsTimepoint: End of study 12 months;Hospitalizations/admission in hospital due to infectionTimepoint: End of study 12 months;Use of Therapeutic antibiotics and duration of their useTimepoint: End of study 12 months;Incidence of new infections other than acute serious bacterial infectionsTimepoint: End of study 12 months | — |
Countries
India
Contacts
Public ContactDr Rajan Manguesh
Bharat serums and Vaccines Ltd
Outcome results
None listed