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Trial · Interventional

CompletedPhase 1Registry data

A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure

Overview

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

Bulgaria

Start
Jul 2014
Primary completion
Apr 2015
Completion
Jun 2015
First posted
17 Mar 2015 (estimated)
Last update posted
17 Sept 2015 (estimated)
Conditions
Congestive Heart Failure

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 1

    A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure

    NCT02388464

    Jul 2014 to Jun 2015

Registry summary

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

This is a Phase 1, single-center, randomized, double-blind, single ascending dose, placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart failure due to left ventricular systolic dysfunction, to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of Bendavia™ (MTP-131).

Interventions

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

Arms4

  • Experimental

    Low dose

  • Experimental

    Intermediate dose

  • Experimental

    High dose

  • Experimental

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of Adverse Events

    Time frame · Assessed up to Day 7

Secondary outcomes(1)
  1. Left ventricular ejection fraction assessed by 2-D echocardiography

    Time frame · Assessed up to 24 hours post-infusion start

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.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

6 results

Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide.

Daubert et al. 2017Circulation. Heart failurecited by 147

PMID 29217757DOI 10.1161/circheartfailure.117.004389PUB-29217757

Rights unknown6 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 45 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Chronic ischemic or non-ischemic cardiomyopathy of at least 6 months duration from the time of the initial diagnosis. * LVEF ≤35% by 2-D echocardiogram. * Diagnosis of NYHA Class II or III HF for a minimum of 6 months prior to the Screening Visit. * HF is considered to be stable and no hospitalization for HF has occurred within the previous 3 months 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 (i.e. carvedilol, bisoprolol, or extended-release metoprolol). * Dose and dose regimen of pharmacologic treatments for HF must be stable for a minimum of 1 month prior to the Screening Visit. * Females of child-bearing potential must have a negative serum pregnancy test at the Screening Visit and Day 1. Exclusion Criteria: * LV end-diastolic dimension (LVEDD), by the same method as qualifying LVEF, is \>80 mm or LVEDD indexed to body surface area is \>0.45. * 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. * Placement of an automated implantable cardioverter defibrillator (AICD) or any hardware associated with resynchronization therapy. * Atrial fibrillation at the Screening or Baseline Visits. * 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 * Cardiac surgery or valvuloplasty within 2 months 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. * Estimated glomerular filtration rate (eGFR) \<40 mL/min, using the Modification of Diet in Renal Disease (MDRD) Study equation * Serologic evidence of hepatitis B or C infection. * Known acquired immunodeficiency syndrome or HIV-positive status, or diagnosis of immunodeficiency. * Other protocol-defined inclusion/exclusion criteria may apply.

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