Heart FailurePhase 2NCT01798745
A Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-54452840 in Participants With Heart Failure and Anti-beta1-adrenergic Receptor Autoantibodies
A Phase 2 study testing JNJ-54452840 in people with Heart Failure, run by Janssen Research & Development, LLC.
Trial summary
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of JNJ-54452840 in participants with heart failure and anti-beta1-adrenergic receptor autoantibodies. 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?
- JNJ-54452840
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2015
- Phase
- Phase 2
- 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
- Must have documented medical history of symptomatic (ie, showing symptoms) reduced ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) heart failure due to either ischemic etiology (decreased blood supply to heart) or non-ischemic dilated cardiomyopathy (heart is weakened and enlarged) for at least 4 months prior to the screening visit
- Must have heart failure classified by the New York Heart Association classification system as class I through IIIa
- Must have a left ventricular ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) of < = 45%
- Must have blood levels of anti-beta1-adrenergic receptor autoantibodies (antibodies that are involved in developing heart failure) that are above the reference range
- Must have been receiving guideline-directed medical therapy for heart failure for at least 4 months prior to screening and, in addition, be receiving stable and individually optimized drug doses for at least 2 months prior to screening.
Who cannot join
- History of, or current active illness that, in the opinion of the investigator, would make participation not in the best interest (eg, compromise the well-being) of the patient or that could interfere with the study assessments
- Left ventricular end-diastolic diameter index (a measure of the heart's performance) of <= 32 mm/m2
- N-terminal pro-brain natriuretic peptide level (a biologic molecule that has been shown to predict cardiac events) that is <= 200 pg/mL in participants with normal sinus rhythm or <= 800 pg/mL in participants with atrial fibrillation
- Chronic treatment with immunosuppressive drugs (except for <= 5 mg/day prednisone-equivalent dose)
- Known allergies to peptides or proteins, such as albumin.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Pharmacokinetic and Pharmacodynamic Two Part Cohort Study of JNJ-54452840 in Subjects With Reduced Systolic Function Heart Failure and Elevated Levels of Anti-Beta 1 Adrenergic Receptor Autoantibodies
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of JNJ-54452840 in participants with heart failure and anti-beta1-adrenergic receptor autoantibodies. The safety and tolerability of JNJ-54452840 will also be assessed.
Read the detailed description
This study will be randomized (the study treatment is assigned by chance), double-blind (neither investigator nor participant knows the treatment received), and placebo-controlled (one of the study treatments is inactive). This study will be conducted in participants with reduced systolic function heart failure (a reduced amount of blood is pumped around the body compared with a normal heart) and elevated levels of anti-beta1-adrenergic receptor autoantibodies (antibodies that may be involved in development, progression, or worsening of heart failure). The study will be conducted in 2 parts; participants will receive single doses of JNJ-54452840 in Part 1 and multiple doses in Part 2. Each part of the study will consist of 3 phases; a screening phase, a double-blind treatment phase, and a follow-up phase. There will be 2 cohorts (groups) of participants in Part 1 of the study. In Part 1 (Cohort A), participants will be randomly assigned to 1 of 4 treatment groups: a single intravenous (medication is injected into a vein) dose of 20 mg JNJ-54452840; a single intravenous dose of 80 mg JNJ-54452840; a single intravenous dose of 160 mg JNJ-54452840; or matching placebo (inactive medication). In Part 1 (Cohort B), participants will be randomly assigned to 1 of 2 treatment groups; a single intravenous dose of less than or equal to 240 mg JNJ-54452840 (as determined by the Data Review Committee after review of Cohort A data) or matching placebo. There will be 4 cohorts of participants in Part 2 of the study; the dose of JNJ-54452840 used in each cohort, initiation of each cohort, and the sequence will be decided by the Data Review Committee. In Part 2 (Cohort C), participants will be randomly assigned to 1 of 2 treatment groups: JNJ-54452840 or matching placebo given intravenously once daily for 3 days. In Part 2 (Cohort D), participants will be randomly assigned to 1 of 2 treatment groups: JNJ-54452840 or matching placebo given intravenously once daily for 5 days. In Part 2 (Cohort E), participants will be randomly assigned to 1 of 2 treatment groups: JNJ-54452840 or matching placebo given intravenously once weekly on Days 1, 8, 15, and 22. In Part 2 (Cohort F), participants will be randomly assigned to 1 or more treatment groups involving regimen(s) as explored in Cohorts C, D, or E. Single doses of JNJ-54452840 will not be greater than 240 mg for any Cohort. The active to placebo randomization ratio for each cohort following Cohort A (ie, Cohorts B, C, D, E, and F) will be determined by the Data Review Committee. Participants will come to the study center each time they receive study medication and will remain at the center for at least two hours following each injection. Blood samples will be drawn at time points during the screening period and treatment period for participants in both Part 1 and Part 2 of the study. Participants will return to the study center after the double-blind treatment phase on Day 29 and then for follow-up visits on Days 57 and 85. Participants in Part 1 or Part 2 will be involved in the study for approximately 112 days. Participant safety will be monitored. The study drug, JNJ-54452480 is being investigated for the treatment of heart failure.
- Conditions
- Heart Failure
- Being tested
- JNJ-54452840, Placebo
- Keywords
- Heart failure, JNJ-54452840, Anti-beta-1 adrenergic receptor auto antibodies, Beta-1 adrenergic receptor, Antibodies, Auto antibodies, Systolic function
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-54452840Drug
Once daily intravenous injection(s) (medication is injected into a vein) at doses ranging from 20 mg to 240 mg, given as a single injection (Cohorts A and B); injections given once daily over 3 to 5 days (Cohorts C, D, and F); or injections given once weekly up to Day 22 (Cohorts E and F).
PlaceboOther
Once daily matching intravenous injection(s) (medication is injected into a vein) given as a single injection (Cohorts A and B); injections given once daily over 3 to 5 days (Cohorts C, D, and F); or injections given once weekly up to Day 22 (Cohorts E and F).
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: JNJ-54452840 20 mg | Experimental | Each patient will receive 20 mg of JNJ-54452840 as a single dose. Receives: Drug: JNJ-54452840 |
| Cohort A: JNJ-54452840 80 mg | Experimental | Each patient will receive 80 mg of JNJ-54452840 as a single dose. Receives: Drug: JNJ-54452840 |
| Cohort A: JNJ-54452840 160 mg | Experimental | Each patient will receive 160 mg of JNJ-54452840 as a single dose. Receives: Drug: JNJ-54452840 |
| Cohort A: Placebo | Placebo comparator | Each patient will receive matching placebo as a single dose. Receives: Other: Placebo |
| Cohort B: JNJ-54452840 <= 240 mg | Experimental | Each patient will receive JNJ-54452840 at a dose of less than or equal to 240 mg as a single dose (dose determined by the Data Monitoring Committee). Receives: Drug: JNJ-54452840 |
| Cohort B: Placebo | Placebo comparator | Each patient will receive matching placebo as a single dose. Receives: Other: Placebo |
| Cohort C: JNJ-54452840 for 3 days | Experimental | Each patient will receive JNJ-54452840 once daily for 3 days at a dose determined by the Data Monitoring Committee (daily dose not exceeding 240 mg). Receives: Drug: JNJ-54452840 |
| Cohort C: Placebo | Placebo comparator | Each patient will receive matching placebo once daily for 3 days. Receives: Other: Placebo |
| Cohort D: JNJ-54452840 for 5 days | Experimental | Each patient will receive JNJ-54452840 once daily for 5 days at a dose determined by the Data Monitoring Committee (daily dose not exceeding 240 mg). Receives: Drug: JNJ-54452840 |
| Cohort D: Placebo | Placebo comparator | Each patient will receive matching placebo once daily for 5 days. Receives: Other: Placebo |
| Cohort E: JNJ-54452840 weekly | Experimental | Each patient will receive JNJ-54452840 once weekly on Days 1, 8, 15, and 22 at a dose determined by the Data Monitoring Committee (daily dose not exceeding 240 mg). Receives: Drug: JNJ-54452840 |
| Cohort E: Placebo | Placebo comparator | Each patient will receive matching placebo once weekly on Days 1, 8, 15, and 22. Receives: Other: Placebo |
| Cohort F: JNJ-54452840 multiple dose | Experimental | Each patient will receive JNJ-54452840 once daily (for 3 or 5 days) or once weekly (up to Day 22) as determined by the Data Monitoring Committee and as explored in Cohorts C, D, and E (daily dose not exceeding 240 mg). Receives: Drug: JNJ-54452840 |
| Cohort F: Placebo | Placebo comparator | Each patient will receive matching placebo once daily (for 3 or 5 days) or once weekly (up to Day 22). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of anti-beta1-adrenergic receptor autoantibody bound JNJ-54452840
Serum levels of bound JNJ-54452840 (ie, amount of drug that is attached to anti-beta1-adrenergic receptor autoantibodies) will be used to determine pharmacokinetic parameters for JNJ-54452840 (measurements describing how the body affects the drug).
Measured: Up to Day 7
Serum levels of free JNJ-54452840
Serum levels of free JNJ-54452840 (ie, amount of drug that is not attached to anti-beta1-adrenergic receptor autoantibodies) will be used to determine pharmacokinetic parameters for JNJ-54452840 (measurements describing how the body affects the drug).
Measured: Up to Day 7
Serum levels of total JNJ-54452840
Serum levels of total JNJ-54452840 (ie, bound drug plus free drug) will be used to determine pharmacokinetic parameters for JNJ-54452840 (measurements describing how the body affects the drug).
Measured: Up to Day 7
Serum levels of anti-beta1-adrenergic receptor autoantibodies
Blood levels of anti-beta1-adrenergic receptor autoantibodies will be used to determine the pharmacodynamics of JNJ-54452840 (ie, how the drug affects the body).
Measured: Up to Day 85
Beta1-adrenergic receptor activation
Beta1-adrenergic receptor activation will be used to determine the pharmacodynamics of JNJ-54452840 (ie, how the drug affects the body).
Measured: Up to Day 29
Secondary outcomes (1)
Number of patients with adverse events
Number of patients with adverse events will be used as a measure of safety and tolerability
Measured: Up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: study not required for development
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.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798745
- Sponsor's protocol ID
- CR100985
- Other IDs
- 54452840HFA2003, 2012-005302-22
- Status last verified
- Apr 2014
- First submitted
- 22 Feb 2013
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Pharmacokinetic and Pharmacodynamic Two Part Cohort Study of JNJ-54452840 in Subjects With Reduced Systolic Function Heart Failure and Elevated Levels of Anti-Beta 1 Adrenergic Receptor Autoantibodies
- ClinicalTrials.gov ID
- NCT01798745
- Acronym / sponsor ID
- CR100985
- Conditions
- Heart Failure
- Keywords
- Heart failure, JNJ-54452840, Anti-beta-1 adrenergic receptor auto antibodies, Beta-1 adrenergic receptor, Antibodies, Auto antibodies, Systolic function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study not required for development
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Feb 2013 (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.
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of JNJ-54452840 in participants with heart failure and anti-beta1-adrenergic receptor autoantibodies. The safety and tolerability of JNJ-54452840 will also be assessed.
Detailed description
This study will be randomized (the study treatment is assigned by chance), double-blind (neither investigator nor participant knows the treatment received), and placebo-controlled (one of the study treatments is inactive). This study will be conducted in participants with reduced systolic function heart failure (a reduced amount of blood is pumped around the body compared with a normal heart) and elevated levels of anti-beta1-adrenergic receptor autoantibodies (antibodies that may be involved in development, progression, or worsening of heart failure). The study will be conducted in 2 parts; participants will receive single doses of JNJ-54452840 in Part 1 and multiple doses in Part 2. Each part of the study will consist of 3 phases; a screening phase, a double-blind treatment phase, and a follow-up phase. There will be 2 cohorts (groups) of participants in Part 1 of the study. In Part 1 (Cohort A), participants will be randomly assigned to 1 of 4 treatment groups: a single intravenous (medication is injected into a vein) dose of 20 mg JNJ-54452840; a single intravenous dose of 80 mg JNJ-54452840; a single intravenous dose of 160 mg JNJ-54452840; or matching placebo (inactive medication). In Part 1 (Cohort B), participants will be randomly assigned to 1 of 2 treatment groups; a single intravenous dose of less than or equal to 240 mg JNJ-54452840 (as determined by the Data Review Committee after review of Cohort A data) or matching placebo. There will be 4 cohorts of participants in Part 2 of the study; the dose of JNJ-54452840 used in each cohort, initiation of each cohort, and the sequence will be decided by the Data Review Committee. In Part 2 (Cohort C), participants will be randomly assigned to 1 of 2 treatment groups: JNJ-54452840 or matching placebo given intravenously once daily for 3 days. In Part 2 (Cohort D), participants will be randomly assigned to 1 of 2 treatment groups: JNJ-54452840 or matching placebo given intravenously once daily for 5 days. In Part 2 (Cohort E), participants will be randomly assigned to 1 of 2 treatment groups: JNJ-54452840 or matching placebo given intravenously once weekly on Days 1, 8, 15, and 22. In Part 2 (Cohort F), participants will be randomly assigned to 1 or more treatment groups involving regimen(s) as explored in Cohorts C, D, or E. Single doses of JNJ-54452840 will not be greater than 240 mg for any Cohort. The active to placebo randomization ratio for each cohort following Cohort A (ie, Cohorts B, C, D, E, and F) will be determined by the Data Review Committee. Participants will come to the study center each time they receive study medication and will remain at the center for at least two hours following each injection. Blood samples will be drawn at time points during the screening period and treatment period for participants in both Part 1 and Part 2 of the study. Participants will return to the study center after the double-blind treatment phase on Day 29 and then for follow-up visits on Days 57 and 85. Participants in Part 1 or Part 2 will be involved in the study for approximately 112 days. Participant safety will be monitored. The study drug, JNJ-54452480 is being investigated for the treatment of heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Cohort A: JNJ-54452840 20 mg | Experimental | Drug: JNJ-54452840Each patient will receive 20 mg of JNJ-54452840 as a single dose. |
| Cohort A: JNJ-54452840 80 mg | Experimental | Drug: JNJ-54452840Each patient will receive 80 mg of JNJ-54452840 as a single dose. |
| Cohort A: JNJ-54452840 160 mg | Experimental | Drug: JNJ-54452840Each patient will receive 160 mg of JNJ-54452840 as a single dose. |
| Cohort A: Placebo | Placebo comparator | Other: PlaceboEach patient will receive matching placebo as a single dose. |
| Cohort B: JNJ-54452840 <= 240 mg | Experimental | Drug: JNJ-54452840Each patient will receive JNJ-54452840 at a dose of less than or equal to 240 mg as a single dose (dose determined by the Data Monitoring Committee). |
| Cohort B: Placebo | Placebo comparator | Other: PlaceboEach patient will receive matching placebo as a single dose. |
| Cohort C: JNJ-54452840 for 3 days | Experimental | Drug: JNJ-54452840Each patient will receive JNJ-54452840 once daily for 3 days at a dose determined by the Data Monitoring Committee (daily dose not exceeding 240 mg). |
| Cohort C: Placebo | Placebo comparator | Other: PlaceboEach patient will receive matching placebo once daily for 3 days. |
| Cohort D: JNJ-54452840 for 5 days | Experimental | Drug: JNJ-54452840Each patient will receive JNJ-54452840 once daily for 5 days at a dose determined by the Data Monitoring Committee (daily dose not exceeding 240 mg). |
| Cohort D: Placebo | Placebo comparator | Other: PlaceboEach patient will receive matching placebo once daily for 5 days. |
| Cohort E: JNJ-54452840 weekly | Experimental | Drug: JNJ-54452840Each patient will receive JNJ-54452840 once weekly on Days 1, 8, 15, and 22 at a dose determined by the Data Monitoring Committee (daily dose not exceeding 240 mg). |
| Cohort E: Placebo | Placebo comparator | Other: PlaceboEach patient will receive matching placebo once weekly on Days 1, 8, 15, and 22. |
| Cohort F: JNJ-54452840 multiple dose | Experimental | Drug: JNJ-54452840Each patient will receive JNJ-54452840 once daily (for 3 or 5 days) or once weekly (up to Day 22) as determined by the Data Monitoring Committee and as explored in Cohorts C, D, and E (daily dose not exceeding 240 mg). |
| Cohort F: Placebo | Placebo comparator | Other: PlaceboEach patient will receive matching placebo once daily (for 3 or 5 days) or once weekly (up to Day 22). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have documented medical history of symptomatic (ie, showing symptoms) reduced ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) heart failure due to either ischemic etiology (decreased blood supply to heart) or non-ischemic dilated cardiomyopathy (heart is weakened and enlarged) for at least 4 months prior to the screening visit
- Must have heart failure classified by the New York Heart Association classification system as class I through IIIa
- Must have a left ventricular ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) of < = 45%
- Must have blood levels of anti-beta1-adrenergic receptor autoantibodies (antibodies that are involved in developing heart failure) that are above the reference range
- Must have been receiving guideline-directed medical therapy for heart failure for at least 4 months prior to screening and, in addition, be receiving stable and individually optimized drug doses for at least 2 months prior to screening.
Key exclusion criteria (5 listed)
- History of, or current active illness that, in the opinion of the investigator, would make participation not in the best interest (eg, compromise the well-being) of the patient or that could interfere with the study assessments
- Left ventricular end-diastolic diameter index (a measure of the heart's performance) of <= 32 mm/m2
- N-terminal pro-brain natriuretic peptide level (a biologic molecule that has been shown to predict cardiac events) that is <= 200 pg/mL in participants with normal sinus rhythm or <= 800 pg/mL in participants with atrial fibrillation
- Chronic treatment with immunosuppressive drugs (except for <= 5 mg/day prednisone-equivalent dose)
- Known allergies to peptides or proteins, such as albumin.
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 |
|---|---|---|
| JNJ-54452840Once daily intravenous injection(s) (medication is injected into a vein) at doses ranging from 20 mg to 240 mg, given as a single injection (Cohorts A and B); injections given once daily over 3 to 5 days (Cohorts C, D, and F); or injections given once weekly up to Day 22 (Cohorts E and F). | Drug | Cohort A: JNJ-54452840 160 mg, Cohort A: JNJ-54452840 20 mg, Cohort A: JNJ-54452840 80 mg, Cohort B: JNJ-54452840 <= 240 mg, Cohort C: JNJ-54452840 for 3 days, Cohort D: JNJ-54452840 for 5 days, Cohort E: JNJ-54452840 weekly, Cohort F: JNJ-54452840 multiple dose |
| PlaceboOnce daily matching intravenous injection(s) (medication is injected into a vein) given as a single injection (Cohorts A and B); injections given once daily over 3 to 5 days (Cohorts C, D, and F); or injections given once weekly up to Day 22 (Cohorts E and F). | Other | Cohort A: Placebo, Cohort B: Placebo, Cohort C: Placebo, Cohort D: Placebo, Cohort E: Placebo, Cohort F: Placebo |
Primary outcome
Serum levels of anti-beta1-adrenergic receptor autoantibody bound JNJ-54452840
Time frame: Up to Day 7
Serum levels of bound JNJ-54452840 (ie, amount of drug that is attached to anti-beta1-adrenergic receptor autoantibodies) will be used to determine pharmacokinetic parameters for JNJ-54452840 (measurements describing how the body affects the drug).
Serum levels of free JNJ-54452840
Time frame: Up to Day 7
Serum levels of free JNJ-54452840 (ie, amount of drug that is not attached to anti-beta1-adrenergic receptor autoantibodies) will be used to determine pharmacokinetic parameters for JNJ-54452840 (measurements describing how the body affects the drug).
Serum levels of total JNJ-54452840
Time frame: Up to Day 7
Serum levels of total JNJ-54452840 (ie, bound drug plus free drug) will be used to determine pharmacokinetic parameters for JNJ-54452840 (measurements describing how the body affects the drug).
Serum levels of anti-beta1-adrenergic receptor autoantibodies
Time frame: Up to Day 85
Blood levels of anti-beta1-adrenergic receptor autoantibodies will be used to determine the pharmacodynamics of JNJ-54452840 (ie, how the drug affects the body).
Beta1-adrenergic receptor activation
Time frame: Up to Day 29
Beta1-adrenergic receptor activation will be used to determine the pharmacodynamics of JNJ-54452840 (ie, how the drug affects the body).
1 secondary outcome
Number of patients with adverse events
Time frame: Up to Day 85
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 9 Apr 2014.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-54452840 in people with Heart Failure, run by Janssen Research & Development, LLC.
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 5 inclusion and 5 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 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Serum levels of anti-beta1-adrenergic receptor autoantibody bound JNJ-54452840 (time frame: Up to Day 7). The study lists 5 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 9 Apr 2014.