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

NCT00610051 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 3-T02-07-0106
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

advanced HFrEF

Outcome Measures

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.

  6 months infusion

Secondary Outcomes (1)

• Secondary Efficacy and Safety Endpoints

  6 months

Study Arms (2)

trial arm

ACTIVE COMPARATOR

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

Drug: Alprostadil

Placebo arm

PLACEBO COMPARATOR

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

Drug: Alprostadil

Interventions

Alprostadil DRUG

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

Placebo arm; trial arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Biopeutics Co., Ltd: lead

Study Sites (1)

Medical university Vienna

Vienna, Austria

Location

MeSH Terms

Interventions

Alprostadil

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Martin Huelsmann, MD

  Medical university Vienna, Department of Cardiology

  PRINCIPAL INVESTIGATOR

• Noemi Pavo, MD PhD

  Medical University Vienna, department of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei K Wang, MD

CONTACT

+886227720395; pei@biopeutics.com

Emily Tai, MA

CONTACT

+886227720395; emilytai@biopeutics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The party or parties involved in the study trials who are prevented from having knowledge of the interventions assigned to individual participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: February 7, 2008
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)