CClinicalTrials.gg
Sign In
Not yet recruitingNCT00610051Updated Dec 15, 2025

ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure

A Phase 3 interventional study of Alprostadil in End Stage Cardiac Failure, HFrEF - Heart Failure With Reduced Ejection Fraction and NYHF Class III-IV, sponsored by Biopeutics Co., Ltd. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by Biopeutics Co., Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • End Stage Cardiac Failure
  • HFrEF - Heart Failure With Reduced Ejection Fraction
  • NYHF Class III-IV

Keywords

  • advanced HFrEF
03

In context

Lead sponsor

This is the only study on the registry with Biopeutics Co., Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  1. Patients older than 18 years of age, of any gender/sex and race/ethnicity

  2. Patients with a diagnosis of advanced HFrEF as evidenced by (all must apply):

    1. most recent LVEF( by conventional imaging method\<30% which was mwasured within 3 months prior randomization.
    2. Nt-proBNP >1500 ng/L or BNP >300 ng/L at prior randomization
    3. New York Heart Association (NYHA) functional class IIIb or IV, i.e., chronic dyspnoea or fatigue at rest or with minimal exertion for at least one month prior to consent.
    4. Renal dysfunction reflected by a glomerular filtration rate (GFR) \<60 mL/min approximated by the Modification of Diet in Renal Disease formula.
    5. A total symptom score of KCCQ of \<70measure within 24 hours of randomization
    6. Patients on all appropriate recommended HF therapy.
  3. Patient should not be receiving continuous or planned intermittent intravenous infusions with a positive inotropic or vasodilator drug in a non-hospitalized setting
  4. Patients should not be considered as candidates for heart transplantation or LVAD for at least 6 months from randomization according to the opinion of the treating physician.

  5. Women of childbearing potential (i.e., who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must commit either to abstain continuously from heterosexual sexual contact or to use at least one "highly effective" method of birth control (e.g., intrauterine device [IUD], hormonal contraception, tubal ligation, or partner's vasectomy) or two "effective" methods (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to screening and throughout study participation.

    Note: As alprostadil is not genotoxic and female sexual partners of male study participants are not likely to have substantial exposure via semen, there are no contraception requirements for men.

  6. Patients must be willing and able to give written informed consent, including local data privacy consents, as required
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    trial arm

    6 months central continuous infusion with Alp\_1 by infusion pump.

    Drug: Alprostadil

  • Placebo comparator
    Placebo arm

    6 months central infusion with NS by infusion pump with exact infusion rat as trial arm.

    Drug: Alprostadil

Interventions

  • DrugAlprostadil

    central venous access continuous delivery with 500mcg/48 hours in active arm

06

What researchers measure

Primary outcomes

  1. Time to all-cause mortality (defined as death, heart transplant, LVAD placement, mechanical circulatory support, or HF event(* hospitalization for HF or unplanned intravenous therapy for HF, ie diurectics, inotropes, vassopressors, or vasodilators.)

    To access the effect of continue 6-months ALP-1infusion at a fixed dose of at 500mcg/48 hr. in patinets with advanced heart failure with reduced ejection fraction(HrEF) compare to placebo.

    Time frame: 6 months infusion

Secondary outcomes

  1. Secondary Efficacy and Safety Endpoints

    . physcians review NYHA HF functional classification

    Time frame: 6 months

07

Study locations

1 site
  • Medical university Vienna
    Vienna, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00610051
Lead sponsor
Biopeutics Co., Ltd
Responsible party
Sponsor
First posted
Feb 7, 2008
Start date
Oct 2026 (estimated)
Primary completion
Nov 2029 (estimated)
Completion
Dec 2030 (estimated)
Last update
Dec 15, 2025

Study contacts

Pei K Wang, MD
Contact
pei@biopeutics.com
+886227720395
Emily Tai, MA
Contact
emilytai@biopeutics.com
+886227720395
Martin Huelsmann, MD
principal investigator · Medical university Vienna, Department of Cardiology
Noemi Pavo, MD PhD
principal investigator · Medical University Vienna, department of Cardiology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion