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PROTECT: Panzyga for prevention of major infections in hypogammaglobulinemic patients on B-cell depletion therapy

2025-522854-37-00Phase 3Authorised

Sponsor
Octapharma Pharmazeutika Produktionsgesellschaft mbH
Start
May 2026
Countries
10
01

Overview

Phase 3, randomised, double-blind trial in hypogammaglobulinemia, autoimmune disease, rheumatism and 13 more comparing Panzyga prophylaxis with Placebo (isotonic saline) (2 arms). Primary endpoint: Occurrence of at least one major infection or death. Planned start May 2026; status: authorised.

02

Drugs

polyvalent human immunoglobulin
03

Conditions

hypogammaglobulinemiaautoimmune diseaserheumatismmultiple sclerosis (MS)rheumatoid arthritis (RA)

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