Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:47 AM
Study NCT ID:
NCT07346859
Status:
RECRUITING
Last Update Posted:
2026-01-16
First Post:
2025-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID)
Sponsor:
Biopharma Plasma LLC
Organization:
Study Overview
Official Title:
Open-label, Multicentre, Tolerability, Safety and Pharmacokinetics Study of the Medicinal Product BP-SCIG 20% (Human Normal Immunoglobulin for Subcutaneous Administration) Manufactured by BIOPHARMA PLASMA LLC, Followed by an Efficacy Assessment of Long-term Use in Patients With Primary Immunodeficiency (PID)
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
All patients will receive the investigational medicinal product BP-SCIG 20%, solution for subcutaneous administration, manufactured by BIOPHARMA PLASMA LLC. A loading dose of IMP may be required (at the Investigator's decision): at least 0.2-0.5 g/kg (1.0-2.5 mL/kg) of body weight. This dose is distributed across several days, with a maximum daily dose of 0.1 to 0.15 g/kg. After achieving a steady-state (minimal) level of IgG, maintenance doses are administered at repeated intervals (approximately once a week) to achieve a cumulative monthly dose of 0.4-0.8 g/kg.
Detailed Description:
The clinical trial will consist of three periods, namely:
screening period: lasting up to 2 months, and involving three screening visits; treatment period (from Cycle 1 visit \[the first 4 administrations of the IMP are to be performed in a hospital setting\] during the 52 weeks to the last visit of Cycle 13).
follow-up period after completion of the last cycle of the treatment period, with a duration of 1 week.
screening period: lasting up to 2 months, and involving three screening visits; treatment period (from Cycle 1 visit \[the first 4 administrations of the IMP are to be performed in a hospital setting\] during the 52 weeks to the last visit of Cycle 13).
follow-up period after completion of the last cycle of the treatment period, with a duration of 1 week.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: