Immunogenicity, Safety, and Efficacy of Zarzio®/Filgrastim HEXAL® in Patients With Severe Chronic Neutropenia

Severe Chronic Neutropenia Clinical Trial

Official title:

Twelve-month Study on the Immunogenicity, Safety, and Efficacy of Zarzio®/Filgrastim HEXAL® in Patients With Severe Chronic Neutropenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01859637
• Other study ID #: EP06-401
• Status: Terminated
• Phase: Phase 4
• First received: May 8, 2013
• Last updated: November 4, 2015
• Start date: May 2011
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

Purpose of the study is to investigate the safety, immunogenicity and the efficacy of Zarzio®/Filgrastim HEXAL® under chromic administration.

Study was initiated as a post marketing authorization commitment to European Medicines Agency (EMA). Subsequent submission of long term safety and immunogenicity data from pooled studies and post-marketing experience have addressed the commitment and study no longer necessary to be continued and hence prematurely terminated.

No patients were ongoing in the study at the time of study termination.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neutropenia
• Severe Chronic Neutropenia

Intervention

Drug:
• Eligible patients will be treated with Zarzio®/Filgrastim HEXAL®

Locations

Country	Name	City	State
Germany	Medizinischen Hochschule (MHH) Hannover	Hannover
Sweden	Karolinska Institut	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Countries where clinical trial is conducted

Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity: Incidences of antibodies will be determined	Descriptive analyses	12 months	Yes
Secondary	Safety: to assess the incidence of (S)AEs	vital signs, blood chemistry, urinanalysis	12 months	Yes