Immunogenicity, Safety, and Efficacy of Zarzio®/Filgrastim HEXAL® in Patients With Severe Chronic Neutropenia
Condition: Severe Chronic Neutropenia
MeSH terms: Neutropenia
Intervention: Filgrastim
Intervention description: Zarzio®/Filgrastim HEXAL® solution for injection was provided in prefilled syringes with two strengths at 300 μg/0.5 ml (30 MU) and 480 μg/0.5 ml (48 MU). Dosage and duration for each patient is as per the recommendations in the SmPC.
Intervention MeSH terms: Lenograstim
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Filgrastim, immunogenicity, severe chronic neutropenia

Summary:

      Purpose of the study is to investigate the safety, immunogenicity and the efficacy of
      Zarzio®/Filgrastim HEXAL® under chronic administration for 12 months in patients diagnosed
      with severe chronic neutropenia.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with established congenital, cyclic or idiopathic severe chronic neutropenia
             having an indication for treatment with Sandoz' filgrastim according to the SmPC of
             the product

          2. Patients ≥ 18 years of age at the day of inclusion

          3. Written informed consent of patient

        Exclusion criteria:.

          1. Chemotherapy-induced neutropenia

          2. Neutropenia in combination with confirmed diagnosis of autoimmune disease, e.g.
             rheumatoid arthritis, Felty's syndrome, or systemic lupus erythematosus

          3. Myelodysplastic syndrome or leukemia

          4. Thrombocytopenia (platelets < 50.000/mm3) or anemia (hemoglobin < 8 g/dl) with the
             exception of patients with Shwachman-Diamond syndrome, glycogen storage disease 1b, or
             Barth's syndrome

          5. Sickle cell disease

          6. History of malignancy of any organ system, treated or untreated, with the exception of
             localized basal cell carcinoma of the skin

          7. For patients with congenital severe chronic neutropenia only: Any cytogenetic
             aberrations in bone marrow aspirates with results not older than six months suspicious
             for malignant transformation.

          8. Known or suspected hypersensitivity to rhG-CSF products

          9. Known or suspected hypersensitivity to any of the excipients of Sandoz' filgrastim
             product

         10. Positive result of anti-rhG-CSF antibody assessment at screening

         11. Absolute and relative contraindications as specified in the SmPC of Sandoz' filgrastim

         12. Drug abuse, substance abuse, or alcohol abuse

         13. Use of any other investigational drug at the time of enrollment, or within 30 days or
             5 half-lives prior to enrollment, whichever is longer

         14. Patients unwilling and/or who are not capable of ensuring compliance with the
             provisions of the study protocol

         15. Pregnant or breastfeeding women where pregnancy is defined as the state of a female
             after conception and until the termination of gestation, confirmed by a positive serum
             hCG laboratory test

         16. Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, UNLESS they are using a highly effective method of birth control
             (i.e. one that results in a less than 1% per year failure rate when used consistently
             and correctly, such as implants, injectables, combined oral contraceptives and
             intrauterine devices (IUDs)). Periodic abstinence (e.g. calendar, ovulation,
             symptothermal, post-ovulation methods) is not acceptable.