Prevention of a Major infection in patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions receiving treatment with B-cell depletion therapy.
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Octapharma Pharmazeutika Produktionsgesellschaft mbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed