Heart FailurePhase 1NCT02388529
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure
A Phase 1 study testing MTP-131 in people with Heart Failure, run by Stealth BioTherapeutics Inc. at 1 site in Bulgaria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- MTP-131
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBulgaria
- Study dates
- May 2015to Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure Due to Reduced Left Ventricular Ejection Fraction
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.
- Conditions
- Heart Failure
- Being tested
- MTP-131, Placebo
- Keywords
- Heart Failure, Bendavia™, MTP-131
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTP-131Drug
MTP-131 (low dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
MTP-131Drug
MTP-131 (intermediate dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
MTP-131Drug
MTP-131 (high dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
PlaceboDrug
Placebo Comparator (at each dose cohort) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Drug: MTP-131 |
| Intermediate dose | Experimental | Not described Receives: Drug: MTP-131 |
| High dose | Experimental | Not described Receives: Drug: MTP-131 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Measured: Assessed up to Day 33
Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort
Measured: Assessed up to Day 12
Secondary outcomes (1)
Changes in echocardiographic LV end-systolic volume (LVESV)
Measured: Assessed up to Day 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stealth BioTherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Carr, PharmD, Study director, Stealth BioTherapeutics Inc.Sotir Marchev, MD,PhD, FESC, Principal investigator, Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388529
- Sponsor's protocol ID
- SPIHF-202
- Status last verified
- Oct 2015
- First submitted
- 1 Mar 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure Due to Reduced Left Ventricular Ejection Fraction
- ClinicalTrials.gov ID
- NCT02388529
- Acronym / sponsor ID
- SPIHF-202
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Bendavia™, MTP-131
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stealth BioTherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: MTP-131 |
| Intermediate dose | Experimental | Drug: MTP-131 |
| High dose | Experimental | Drug: MTP-131 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTP-131MTP-131 (low dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days | Drug | Low dose |
| MTP-131MTP-131 (intermediate dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days | Drug | Intermediate dose |
| MTP-131MTP-131 (high dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days | Drug | High dose |
| PlaceboPlacebo Comparator (at each dose cohort) administered as once-daily 1- hour intravenous infusion for 5 consecutive days | Drug | Placebo |
Primary outcome
Incidence of Adverse Events
Time frame: Assessed up to Day 33
Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort
Time frame: Assessed up to Day 12
1 secondary outcome
Changes in echocardiographic LV end-systolic volume (LVESV)
Time frame: Assessed up to Day 33
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Carr, PharmD study director
Stealth BioTherapeutics Inc.
Sotir Marchev, MD,PhD, FESC principal investigator
Bulgaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MTP-131 in people with Heart Failure, run by Stealth BioTherapeutics Inc. at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 15 Oct 2015. 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 Bulgaria. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Assessed up to Day 33). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2015.