Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-10
Brief Title:
P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk
Sponsor:
PharmaEssentia
Organization:
PharmaEssentia
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b P1101 in Adult Patients With Pre-fibroticEarly Primary Myelofibrosis PMF or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b P1101 in adult patients with Primary Myelofibrosis PMF at early stage or low to medium risk
Participants will receive the study drugplacebo bi-weekly and have an assessment visit every 4 weeks The ratio of study drug to placebo group is 21
Participants will receive the study drugplacebo bi-weekly and have an assessment visit every 4 weeks The ratio of study drug to placebo group is 21
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None