Severe Chronic Neutropenia International Registry Protocol

Recruiting
100 years or below
All
Phase N/A
1 Location

Brief description of study

The objective of the registry is to collect information on the natural course of severe chronic neutropenia (SCN) and its response to treatment with the blood-stimulating factor called granulocyte colony stimulating factor or G-CSF (Neupogen).

Detailed description of study

The objective of the registry is to collect information on the natural course of severe chronic neutropenia (SCN) and its response to treatment with the blood-stimulating factor called granulocyte colony stimulating factor or G-CSF (Neupogen).

Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Severe Chronic Neutropenia,Chronic Neutropenia,Severe Neutropenia,Neutropenia
  • Age: 100 years or below
  • Gender: All

Inclusion Criteria
A confirmed diagnosis of severe chronic neutropenia based on documented absolute neutrophil counts in the three months prior to enrollment.
Bone marrow aspiration consistent with the diagnosis of congenital, cyclic or idiopathic neutropenia.
Normal cytogenetic evaluation.
History of recurrent infections (i.e. severe mouth ulcers, gingivitis and sinusitis).
Age greater than three months.
Independent of hematological parameters, patients with the following diagnoses may be included: Shwachman-Diamond syndrome (SDS), glycogen storage disease type Ib (GSD1b), Barth syndrome.
Patients with moderately severe chronic neutropenia and recurrent severe infections (i.e., deep tissue infections of subcutaneous areas, lungs, liver, etc.).
Immune neutropenia with positive anti-neutrophil antibodies meeting criteria in 1, 3, 5 and 6.
All SCN patients previously enrolled in Amgen-sponsored SCN studies.
Exclusion Criteria
Neutropenia known to be drug induced.
Primary myelodysplasia
Primary leukemia
Aplastic anemia
Known HIV disease
Systemic autoimmune diseases such as rheumatoid arthritis or systemic lupus, erythematosus
Chemotherapy-induced neutropenia (within the last 5 years)

Updated on 04 Aug 2024. Study ID: 1011004393

Find a site

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Zip Code
Please provide your 5-digit zip code
0 0 /250
Other language

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the study team