AzTrials
AzTrials

End Stage Cardiac FailurePhase 3NCT00610051

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

A Phase 3 study testing Alprostadil in people with End Stage Cardiac Failure and HFrEF - Heart Failure With Reduced Ejection Fraction, run by Biopeutics Co., Ltd at 1 site in Austria.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Alprostadil
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
1 siteAustria
Study dates
Oct 2026to Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  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):
  3. most recent LVEF( by conventional imaging method<30% which was mwasured within 3 months prior randomization.
  4. Nt-proBNP >1500 ng/L or BNP >300 ng/L at prior randomization
  5. 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.
  6. Renal dysfunction reflected by a glomerular filtration rate (GFR) <60 mL/min approximated by the Modification of Diet in Renal Disease formula.
  7. A total symptom score of KCCQ of <70measure within 24 hours of randomization
  8. Patients on all appropriate recommended HF therapy.
  9. Patient should not be receiving continuous or planned intermittent intravenous infusions with a positive inotropic or vasodilator drug in a non-hospitalized setting
  10. 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.
  11. 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.
  12. Patients must be willing and able to give written informed consent, including local data privacy consents, as required

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pei K Wang, MD contact

+886227720395

pei@biopeutics.com

Emily Tai, MA contact

+886227720395

emilytai@biopeutics.com

Austria1 site

  • Medical university Vienna

    Vienna

Other trials in Austria

About this study

Official title: Phase 3 Study of Alprostadil Continuous Intravenous Infusion to Maintain Clinical Stability in Severe Heart Failure Patients

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).

Being tested
Alprostadil
Keywords
advanced HFrEF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlprostadilDrug

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

Study groups in NCT00610051
Study groupRoleWhat they receive
trial armActive comparator6 months central continuous infusion with Alp_1 by infusion pump.
Receives: Drug: Alprostadil
Placebo armPlacebo comparator6 months central infusion with NS by infusion pump with exact infusion rat as trial arm.
Receives: Drug: Alprostadil

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months infusion

Secondary outcomes (1)

  1. Secondary Efficacy and Safety Endpoints

    . physcians review NYHA HF functional classification

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2008 (estimated)
  2. Study startOct 2026 (estimated)
  3. Primary completionNov 2029 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This multicenter, double-blind, placebo-controlled, randomized, parallel-group trial will study up to approximately 400 patients with advanced HFrEF who are not expected to receive heart transplant or LVAD placement for 6 months after enrollment. Eligible patients will be randomized (1:1) to receive either alprostadil 250 μg/day, regardless of body weight, or placebo (normal saline) given in a continuous infusion. Primary objective is to evaluate the effect of continue alprostadil infsuion, 250 mcg/day on major outcome up to 6 months after randomization. Secondary Objectives are to assess the safety of continunous infsuion alprostadil 250mcg/day. Other Obectives are to evaluate the effictiveness and safety of continuous alprostadil infusion on other efficacy and patient health care related outcomes.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00610051
Sponsor's protocol ID
3-T02-07-0106
Status last verified
Dec 2025
First submitted
14 Jan 2008
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alprostadil in people with End Stage Cardiac Failure and HFrEF - Heart Failure With Reduced Ejection Fraction, run by Biopeutics Co., Ltd at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pei K Wang, MD (+886227720395, pei@biopeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.) (time frame: 6 months infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00610051.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in