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Trial · Interventional

WithdrawnPhase 1Registry data

A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure

Overview

Status
Withdrawn
Phase
Phase 1
Enrollment
0 participants (actual)
Sponsor
Stealth BioTherapeutics Inc. · Industry
Design
Randomized · Triple masking
Countries
1 country

Bulgaria

Start
May 2015
Primary completion
Sept 2015 (estimated)
Completion
Oct 2015 (estimated)
First posted
17 Mar 2015 (estimated)
Last update posted
15 Oct 2015 (estimated)
Conditions
Heart Failure

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016
  1. Ph 1

    A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure

    NCT02388529

    May 2015 to est. Oct 2015

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is a single-center, randomized, double-blind, placebo-controlled study in patients with stable heart failure to evaluate the safety, tolerability, pharmacokinetics, and efficacy of multiple ascending doses of Bendavia™ (MTP-131) intravenous infusion.

Interventions

  • MTP-131Drug
  • MTP-131Drug
  • MTP-131Drug
  • PlaceboDrug

Arms4

  • Experimental

    Low dose

  • Experimental

    Intermediate dose

  • Experimental

    High dose

  • Placebo comparator

    Placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Incidence of Adverse Events

    Time frame · Assessed up to Day 33

  2. Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort

    Time frame · Assessed up to Day 12

Secondary outcomes(1)
  1. Changes in echocardiographic LV end-systolic volume (LVESV)

    Time frame · Assessed up to Day 33

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * LVEF ≤45% by 2-D echocardiogram. * Diagnosis of New York Heart Association Class II or III HF for a minimum of 6 months prior to the Screening Visit. * HF is considered to be stable, in the judgment of the Principal Investigator and no hospitalization related to HF has occurred within the 1 month prior to the Screening Visit. * Treatment with appropriate pharmacologic therapy for HF including, but not limited to, angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB), and an evidence-based beta blocker for the treatment of HF * Females of child-bearing potential must have a negative serum pregnancy test at the Screening Visit. * Written informed consent obtained that strictly adheres to the written guidelines from the local Ethical Committee (EC). Exclusion Criteria: * Unstable angina pectoris within 1 month before initiation of screening procedures. Unstable angina is defined as the occurrence of chest pain more frequently than usual, pain at rest or upon minimal exertion, or protracted episodes of pain without any discernible trigger, and/or chest pain that persists despite use of vasodilatory therapy (e.g., nitroglycerin). * Coronary or peripheral artery revascularization procedure within 2 months prior to the Screening Visit. * An acute myocardial infarction within 3 months prior to the Screening Visit. * Supine resting heart rate ≥ 100 beats per minute after 5 minutes rest. * Uncontrolled hypertension defined as a systolic blood pressure (BP) \>180 mm Hg or a diastolic BP \>110 mm Hg on at least 2 consecutive readings. * Requirement for valve or other cardiac surgery (e.g., pericardectomy). * Cardiac surgery or valvuloplasty within 2 month prior to the Screening Visit. * General surgery within 1 month prior to the Screening Visit. * Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic left ventricular aneurysm. * Cerebrovascular accident or transient ischemic attack within 3 months prior to the Screening Visit. * Liver enzyme (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]) elevation \>3x the upper limit of normal (ULN). * Estimated glomerular filtration rate (eGFR) \<30 mL/min, using the Modification of Diet in Renal Disease (MDRD) Study equation. * Known active drug or alcohol abuse. * Active infection requiring systemic treatment or surgical intervention. * Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study. * Female patients who are pregnant or breastfeeding. * Other protocol-defined inclusion/exclusion criteria may apply.

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