Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514807
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Single Arm Multicentre Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients Who Are Intolerant or Refractory to or Not Eligible for Other Cytoreductive Treatments
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to assess the efficacy of ropeginterferon alfa-2b in patients with ET who need cytoreductive treatment but are intolerant or refractory to andor ineligible for cytoreductive treatments approved and available for the treatment of ET ie HU ANA BUS and PB when they are available and approved for ET treatment
Ropeginterferon alfa-2b is currently the only interferon authorised as a cytoreductive treatment of a myeloproliferative neoplasm MPN and the long-term treatment data from its comprehensive clinical development program show its efficacy in the induction of haematologic remission resolution of disease-associated symptoms disease-modifying effect as well as its favourable safety profile Gisslinger et al 2020 Kiladjian et al 2022
Available clinical data and experience show that ropeginterferon alfa-2b normalises various haematological parameters including platelets In addition suppression of the malignant clone causing ET may be achieved at least after long-term treatment which is expected to possibly defer the onset of or avoid long-term sequelae of ET
Ropeginterferon alfa-2b is currently the only interferon authorised as a cytoreductive treatment of a myeloproliferative neoplasm MPN and the long-term treatment data from its comprehensive clinical development program show its efficacy in the induction of haematologic remission resolution of disease-associated symptoms disease-modifying effect as well as its favourable safety profile Gisslinger et al 2020 Kiladjian et al 2022
Available clinical data and experience show that ropeginterferon alfa-2b normalises various haematological parameters including platelets In addition suppression of the malignant clone causing ET may be achieved at least after long-term treatment which is expected to possibly defer the onset of or avoid long-term sequelae of ET
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None