Follow-up of Severe Congenital Neutropenia Patients Receiving PegGCSF (PD lasta); Study of Early and Late Drug Complications
Phase 1
Recruiting
- Conditions
- Congenital Neutropenia.Neutropenia
- Registration Number
- IRCT20150125020786N3
- Lead Sponsor
- Pouyesh Darou biopharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Adult patients and children with severe congenital neutropenia over 12 years
Severe Congenital Neutropenia Patients
Myeloid maturation arrest in bone marrow
Already successfully treated with Filgrastim
Negative mutation in GCSF receptor
Normal spleen and liver in abdominal sonography
Consent to Participate in study and sign inform consent
Cooperative patient for close follow-up
Exclusion Criteria
Secondary neutropenia due to chemotherapy or other diseases
Life-threatening complications such as anaphylaxis or splenic rupture due to Filgrastim
Uncooperative patient for close follow-up
Severe Spleenomegaly
patients with other chronic diseases such as heart or hepatic disease or ...
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute Neutrophil Count. Timepoint: first day of study , 7th day, 14th day, 21st day, 28th day, 35th day, 42nd day, 49th day, 56th day, 3th day, 70th day, 77th day, 84th day, 91st day then every month until reciving the drug. Method of measurement: Blood Sample.
- Secondary Outcome Measures
Name Time Method Infection. Timepoint: Monthly. Method of measurement: Clinical questionnare.;Hospitalization rate. Timepoint: Monthly. Method of measurement: Clinical questionnare.