Primary infection prophylaxis in patients with chronic lymphocytic leukemia (CLL) and secondary hypogammaglobulinemia.
Conditions
Brief summary
Since the study objective is to show the benefit of Panzyga administration as primary infection prophylaxis, the primary endpoint is not the major infection rate but occurrence of at least one major infection in CLL patients with or without primary infection prophylaxis with Panzyga. Please refer to the Protocol for more information on the Primary endpoint.
Detailed description
1. Overall infection rate: infection rate for all infections., 2. Frequency of prophylaxis with anti-infectives (antibacterials and antivirals)., 3. Duration of prophylaxis with anti-infectives (antibacterials and antivirals).
Interventions
Sponsors
Octapharma Pharmazeutika Produktionsgesellschaft mbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Since the study objective is to show the benefit of Panzyga administration as primary infection prophylaxis, the primary endpoint is not the major infection rate but occurrence of at least one major infection in CLL patients with or without primary infection prophylaxis with Panzyga. Please refer to the Protocol for more information on the Primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall infection rate: infection rate for all infections., 2. Frequency of prophylaxis with anti-infectives (antibacterials and antivirals)., 3. Duration of prophylaxis with anti-infectives (antibacterials and antivirals). | — |
Countries
Czechia, Denmark, Greece, Hungary, Italy, Poland, Spain
Outcome results
None listed