Status:
TERMINATED
Immunogenicity, Safety, and Efficacy of Zarzio®/Filgrastim HEXAL® in Patients With Severe Chronic Neutropenia
Lead Sponsor:
Sandoz
Collaborating Sponsors:
Sandoz GmbH
Conditions:
Severe Chronic Neutropenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 neu...
Detailed Description
This was a prospective, open-label, non-comparative study. Eligible patients with Severe Chronic Neutropenia received Zarzio® for 12 months. Study visits were scheduled for screening, start of treatme...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Patients ≥ 18 years of age at the day of inclusion
- Written informed consent of patient
- Exclusion criteria:.
- Chemotherapy-induced neutropenia
- Neutropenia in combination with confirmed diagnosis of autoimmune disease, e.g. rheumatoid arthritis, Felty's syndrome, or systemic lupus erythematosus
- Myelodysplastic syndrome or leukemia
- 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
- Sickle cell disease
- History of malignancy of any organ system, treated or untreated, with the exception of localized basal cell carcinoma of the skin
- 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.
- Known or suspected hypersensitivity to rhG-CSF products
- Known or suspected hypersensitivity to any of the excipients of Sandoz' filgrastim product
- Positive result of anti-rhG-CSF antibody assessment at screening
- Absolute and relative contraindications as specified in the SmPC of Sandoz' filgrastim
- Drug abuse, substance abuse, or alcohol abuse
- 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
- Patients unwilling and/or who are not capable of ensuring compliance with the provisions of the study protocol
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01859637
Start Date
July 1 2011
End Date
September 1 2015
Last Update
March 28 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Medizinischen Hochschule (MHH) Hannover
Hanover, Germany
2
Karolinska Institut
Stockholm, Sweden