Stable Coronary Heart DiseasePhase 2NCT03351738

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease

A Phase 2 study testing MEDI5884 in people with Stable Coronary Heart Disease, run by MedImmune LLC at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease. Read more about this study

Who is it for?: Ages 45 to 80 years
Conditions the study is for: Stable Coronary Heart Disease
What is being tested?: MEDI5884
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 133 participants
Where: 23 sitesUnited States
Study dates: 13 Dec 2017to 9 Nov 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of stable coronary heart disease prior to screening
Currently receiving high intensity statin(s)

Who cannot join

Unstable cardiovascular conditions
Any planned arterial revascularizations
Fasting Laboratory values at screening: Triglycerides > 500 mg/dl, Low Density Lipoprotein-Cholesterol > 100 mg/dL
Any disease or condition or laboratory value that would place the participant at an unacceptable risk.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Research Site
Anniston, Alabama, 36207
Research Site
Cincinnati, Ohio, 45219
Research Site
El Cajon, California, 92020
Research Site
Evanston, Illinois, 60201
Research Site
Fargo, North Dakota, 58103
Research Site
Fleming Island, Florida, 32003
Research Site
Huntsville, Alabama, 35801
Research Site
Indianapolis, Indiana, 46260
Research Site
Jacksonville, Florida, 32216
Research Site
Kingsport, Tennessee, 37660
Research Site
Lincoln, California, 95648
Research Site
Louisville, Kentucky, 40213
Research Site
Marion, Ohio, 43302
Research Site
McAllen, Texas, 78503
Research Site
Northridge, California, 91325
Research Site
Oklahoma City, Oklahoma, 73134
Research Site
Pembroke Pines, Florida, 33024
Research Site
Port Orange, Florida, 32127
Research Site
Rapid City, South Dakota, 57701
Research Site
San Antonio, Texas, 78228
Research Site
Savannah, Georgia, 31406
Research Site
Stow, Ohio, 44224
Research Site
Waterbury, Connecticut, 06708

Other trials in United States

About this study

Official title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Subjects With Stable Coronary Heart Disease

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease.

Read the detailed description

A Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Participants with Stable Coronary Heart Disease.

Conditions: Stable Coronary Heart Disease
Being tested: MEDI5884, Placebo
Keywords: Coronary heart disease, Pharmacokinetic, Pharmacodynamics
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDI5884Drug
Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
PlaceboDrug
Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.

Study groups in NCT03351738
Study group	Role	What they receive
Placebo	Placebo comparator	Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61. Receives: Drug: Placebo
MEDI5884 50 mg	Experimental	Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61. Receives: Drug: MEDI5884
MEDI5884 100 mg	Experimental	Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61. Receives: Drug: MEDI5884
MEDI5884 200 mg	Experimental	Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61. Receives: Drug: MEDI5884
MEDI5884 350 mg	Experimental	Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61. Receives: Drug: MEDI5884
MEDI5884 500 mg	Experimental	Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61. Receives: Drug: MEDI5884

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Measured: Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline
Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.
Measured: Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Vital Signs From Baseline
Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.
Measured: Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline
Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.
Measured: Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Physical Examinations From Baseline
Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.
Measured: Day 1 (Baseline) through Day 241

Secondary outcomes (6)

Change From Baseline in Apolipoprotein B
Change from baseline in apolipoprotein B is reported.
Measured: Day 1 (Baseline), and Days 31, 61, and 91
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
Percent change from baseline in HDL-C is reported.
Measured: Day 1 (Baseline), and Days 31, 61, and 91
Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884
AUC30d after the last dose of MEDI5884 is reported.
Measured: Day 61 (pre-dose), and on Days 64, 68, 71, and 91
Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose
Maximum observed serum concentration (Cmax) of MEDI5884 after the last dose is reported.
Measured: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose
Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI5884 after the last dose is reported.
Measured: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884
Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post baseline-positive only) and treatment-boosted ADA (baseline ADA titer that was boosted to a 4-fold or higher level following drug administration).
Measured: Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 20179 Nov 2018

First posted24 Nov 2017
Study start13 Dec 2017
Primary completion9 Nov 2018
Study completion9 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stable Coronary Heart DiseaseStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03351738
Sponsor's protocol ID: D7870C00002
Status last verified: Mar 2020
First submitted: 12 Oct 2017
Last updated: 23 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ruff CT, Koren MJ, Grimsby J, Rosenbaum AI, Tu X, Karathanasis SK, Falloon J, Hsia J, Guan Y, Conway J, Tsai LF, Hummer BT, Hirshberg B, Kuder JF, Murphy SA, George RT, Sabatine MS. LEGACY: Phase 2a Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of the Anti-EL (Endothelial Lipase) Antibody MEDI5884 in Patients With Stable Coronary Artery Disease. Arterioscler Thromb Vasc Biol. 2021 Dec;41(12):3005-3014. doi: 10.1161/ATVBAHA.120.315757. Epub 2021 Oct 28.
PubMed 34706556

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
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All Stable Coronary Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Subjects With Stable Coronary Heart Disease
ClinicalTrials.gov ID: NCT03351738
Acronym / sponsor ID: D7870C00002
Conditions: Stable Coronary Heart Disease
Keywords: Coronary heart disease, Pharmacokinetic, Pharmacodynamics
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: 13 Dec 2017 (actual)
Primary completion: 9 Nov 2018 (actual)
Study completion: 9 Nov 2018 (actual)
First posted: 24 Nov 2017 (actual)
Results: Posted 19 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Experimental	Drug: MEDI5884Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Experimental	Drug: MEDI5884Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Experimental	Drug: MEDI5884Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Experimental	Drug: MEDI5884Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Experimental	Drug: MEDI5884Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Who may qualify

Ages: 45 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of stable coronary heart disease prior to screening
Currently receiving high intensity statin(s)

Key exclusion criteria (4 listed)

Unstable cardiovascular conditions
Any planned arterial revascularizations
Fasting Laboratory values at screening: Triglycerides > 500 mg/dl, Low Density Lipoprotein-Cholesterol > 100 mg/dL
Any disease or condition or laboratory value that would place the participant at an unacceptable risk.

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
MEDI5884Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.	Drug	MEDI5884 100 mg, MEDI5884 200 mg, MEDI5884 350 mg, MEDI5884 50 mg, MEDI5884 500 mg
PlaceboParticipants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.	Drug	Placebo

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 (Baseline) through Day 241
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline
Time frame: Day 1 (Baseline) through Day 241
Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.
Number of Participants With Clinically Important Changes in Vital Signs From Baseline
Time frame: Day 1 (Baseline) through Day 241
Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.
Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline
Time frame: Day 1 (Baseline) through Day 241
Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.
Number of Participants With Clinically Important Changes in Physical Examinations From Baseline
Time frame: Day 1 (Baseline) through Day 241
Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.

6 secondary outcomes

Change From Baseline in Apolipoprotein B
Time frame: Day 1 (Baseline), and Days 31, 61, and 91
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
Time frame: Day 1 (Baseline), and Days 31, 61, and 91
Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884
Time frame: Day 61 (pre-dose), and on Days 64, 68, 71, and 91
Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose
Time frame: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose
Time frame: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884
Time frame: Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241

Results and safety

Results posted to the registry on 19 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	23	23
MEDI5884 50 mg	20	19
MEDI5884 100 mg	24	24
MEDI5884 200 mg	22	21
MEDI5884 350 mg	21	21
MEDI5884 500 mg	22	22

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Time frame: Day 1 (Baseline) through Day 241. Count of participants. Unit: Participants

Measure	Placebo n = 23	MEDI5884 50 mg n = 20	MEDI5884 100 mg n = 24	MEDI5884 200 mg n = 22	MEDI5884 350 mg n = 21	MEDI5884 500 mg n = 22
TEAEs	17	10	11	12	13	13
TESAEs	2	2	1	0	4	0

Population analysed: As-treated population: All participants who received any dose of study drug and analyzed according to actual treatment they received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated anti-drug antibodies (ADA), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) levels at Day 151 visit.

Primary outcome: Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline

Time frame: Day 1 (Baseline) through Day 241. Count of participants. Unit: Participants

Measure	Placebo n = 23	MEDI5884 50 mg n = 20	MEDI5884 100 mg n = 24	MEDI5884 200 mg n = 22	MEDI5884 350 mg n = 21	MEDI5884 500 mg n = 22
Value	0	0	0	0	0	0

Population analysed: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.

Primary outcome: Number of Participants With Clinically Important Changes in Vital Signs From Baseline

Time frame: Day 1 (Baseline) through Day 241. Count of participants. Unit: Participants

Measure	Placebo n = 23	MEDI5884 50 mg n = 20	MEDI5884 100 mg n = 24	MEDI5884 200 mg n = 22	MEDI5884 350 mg n = 21	MEDI5884 500 mg n = 22
Value	0	0	0	0	0	0

Primary outcome: Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline

Time frame: Day 1 (Baseline) through Day 241. Count of participants. Unit: Participants

Measure	Placebo n = 23	MEDI5884 50 mg n = 20	MEDI5884 100 mg n = 24	MEDI5884 200 mg n = 22	MEDI5884 350 mg n = 21	MEDI5884 500 mg n = 22
Value	0	0	0	0	0	0

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 through Day 241. Other adverse events reported at 4.3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 23 (8.7%)	9 of 23 (39.1%)	0 of 23
MEDI5884 50 mg	2 of 20 (10%)	9 of 20 (45%)	0 of 20
MEDI5884 100 mg	1 of 24 (4.2%)	6 of 24 (25%)	0 of 24
MEDI5884 200 mg	0 of 22 (0%)	12 of 22 (54.5%)	0 of 22
MEDI5884 350 mg	4 of 21 (19%)	13 of 21 (61.9%)	0 of 21
MEDI5884 500 mg	0 of 22 (0%)	13 of 22 (59.1%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34706556Ruff CT, Koren MJ, Grimsby J, Rosenbaum AI, Tu X, Karathanasis SK, Falloon J, Hsia J, Guan Y, Conway J, Tsai LF, Hummer BT, Hirshberg B, Kuder JF, Murphy SA, George RT, Sabatine MS. LEGACY: Phase 2a Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of the Anti-EL (Endothelial Lipase) Antibody MEDI5884 in Patients With Stable Coronary Artery Disease. Arterioscler Thromb Vasc Biol. 2021 Dec;41(12):3005-3014. doi: 10.1161/ATVBAHA.120.315757. Epub 2021 Oct 28.
D7870C00002 Clinical Protocol RedactedLink provided by the sponsor.
D7870C00002 Statistical Analysis Plan RedactedLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Michael J Koren, MD, FACC principal investigator

Jacksonville Center For Clinical Research

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI5884 in people with Stable Coronary Heart Disease, run by MedImmune LLC at 23 sites in United States.

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. 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 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?

Yes. Results are posted in the registry (first posted 19 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) (time frame: Day 1 (Baseline) through Day 241). 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?

On the ClinicalTrials.gov record for NCT03351738, which also lists 1 linked publication.

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 23 Mar 2020.