Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT00610051
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2008-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure
Sponsor:
Biopeutics Co., Ltd
Organization:
Study Overview
Official Title:
Phase 3 Study of Alprostadil Continuous Intravenous Infusion to Maintain Clinical Stability in Severe Heart Failure Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
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 global multicenter, doubleblind, placebo-controlled, randomized, parallel-group study that compares ALP-1 given in a continuous infusion ( compared to placebo), 250mcg/day on majore outcomes up to 6 months after randomization in participants with advanced HF with reduced ejection fraction(HFrEF).
Detailed Description:
We anticipate needing to screen ca. 600 patients in order to ransomize our target sample size of 400 participants. Participants will be randomozed 1:1to receive either alprostadil or placebo. Based on prior data, we expect the 6-month event rate to be 64% in the control group and 47% in the intervention group.
The planned duration of following-up for each patient is 6 months on the randomized trial intervention and a final follow-up visit will be performed 30 days after stopping the trial intervention. Eligible patients will be randomzied via a centralized IXRS to eith alprstadil or placebo. The planned study dusration is approximately 3-4 years from first randomized patient to last patient.
When a participant is deemed eligible to participate in the trial, a central line which will be used for infusion of double-blind treatment will be inserted, if not already in place. Continue infusion delivery system will be operated by a pump.
Infusion of trial intervention will be initiated while the participant is in the hospital of infusion centre and the participant is to remain under observation for at least 8 hours for monitoring of vital signs and adverse event(AEs).
The planned duration of following-up for each patient is 6 months on the randomized trial intervention and a final follow-up visit will be performed 30 days after stopping the trial intervention. Eligible patients will be randomzied via a centralized IXRS to eith alprstadil or placebo. The planned study dusration is approximately 3-4 years from first randomized patient to last patient.
When a participant is deemed eligible to participate in the trial, a central line which will be used for infusion of double-blind treatment will be inserted, if not already in place. Continue infusion delivery system will be operated by a pump.
Infusion of trial intervention will be initiated while the participant is in the hospital of infusion centre and the participant is to remain under observation for at least 8 hours for monitoring of vital signs and adverse event(AEs).
Study Oversight
Has Oversight DMC:
True
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?: