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Follow-up of Severe Congenital Neutropenia Patients Receiving PegGCSF (PD lasta); Study of Early and Late Drug Complications

Follow-up of Severe Congenital Neutropenia Patients Receiving PegGCSF (PD lasta); Study of Early and Late Drug Complications

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150125020786N3
Enrollment
10
Registered
2018-07-08
Start date
2018-07-23
Completion date
Unknown
Last updated
2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Neutropenia. Neutropenia

Interventions

PegGCSF produced by Pouyesh Darou Prescribed weekly or every 2 weeks and the dose will be adjusted based on response to drug.

Sponsors

Pouyesh Darou biopharmaceutical Co.
Lead Sponsor
Immunology, Asthma and Allergy research Institute
Collaborator

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

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

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 ...

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Infection. Timepoint: Monthly. Method of measurement: Clinical questionnare.;Hospitalization rate. Timepoint: Monthly. Method of measurement: Clinical questionnare.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzieh Maddah

Immunology, Asthma and Allergy Research Institute

marzieh.maddah@gmail.com+98 21 6693 5855

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026