Authorised Therapeutic exploratory (Phase II) Severe chronic neutropenia (SCN)

Use of pegfilgrastim in severe chronic neutropenia

EU CTIS ID: 2024-519009-36-01

What this study is testing

Evaluation of the pegG-CSF efficacy in maintaining absolute neutrophil values above 1000/mmc in patients affected with severe chronic neutropenia (SCN) already being treated with G-CSF (once daily) and anti-infective therapy.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patients, none age limits, affected with either congenital or acquired chronic neutropenia defined as absolute neutrophil count < 500/mmc (based on three consecutive tests at least one week apart within a minimum three-months period) already being treated with G-CSF (daily).

You likely can't join if

  • Subjects affected with autoimmune neutropenias or idiopathic neutropenia that are not being treated/occasionally treated with growth factor
  • Subjects affected with iatrogenic neutropenia anticancer drug-induced
  • Subject affected with neutropenia induced by myelodysplastic syndrome and or leukemia with/without clonal cytogenetic abnormalities
  • Subject affected with acquired or congenital neutropenia diagnosis
  • Subjects affected with hepatic or renal impairment
  • Subjects affected with homozygous sickle cell disease or subjects affected with double heterozygosity inheritance of HbS and β-thalassemia
See the full eligibility criteria
Who can join
  • Patients, none age limits, affected with either congenital or acquired chronic neutropenia defined as absolute neutrophil count < 500/mmc (based on three consecutive tests at least one week apart within a minimum three-months period) already being treated with G-CSF (daily).
What rules you out
  • Subjects affected with autoimmune neutropenias or idiopathic neutropenia that are not being treated/occasionally treated with growth factor
  • Subjects affected with iatrogenic neutropenia anticancer drug-induced
  • Subject affected with neutropenia induced by myelodysplastic syndrome and or leukemia with/without clonal cytogenetic abnormalities
  • Subject affected with acquired or congenital neutropenia diagnosis
  • Subjects affected with hepatic or renal impairment
  • Subjects affected with homozygous sickle cell disease or subjects affected with double heterozygosity inheritance of HbS and β-thalassemia
  • Pregnancy and nursing woman

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.