A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infections in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy ("PROTECT")

Condition studied

Prevention of a Major infection in patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions receiving treatment with B-cell depletion therapy.

Investigational medicinal product(s)

Eligibility

Primary endpoint

Occurrence of at least one major infection or death in patients with or without primary infection prophylaxis with Panzyga. Major infections will be recorded throughout the study along with the type and severity of infection and time to resolution. Each patient will be counted only once for the primary endpoint calculation. Each potential infection will be assessed by an Independent Adjudication Committee (IAC) consisting of clinical experts.

Endpoint detail

1. Efficacy Endpoint: The time to first major infection (as assessed by the IAC) or death., 2. Safety Endpoint: Incidence of AEs, 3. Safety Endpoint: Changes from Baseline in physical examinations, and clinical laboratory parameters.