Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04732221
Registration number
NCT04732221
Ethics application status
Date submitted
27/01/2021
Date registered
1/02/2021
Date last updated
25/05/2025
Titles & IDs
Public title
A Study of the Efficacy and Safety of Frespaciguat (MK-5475) in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)
Query!
Scientific title
A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Arterial Hypertension
Query!
Secondary ID [1]
0
0
MK-5475-007
Query!
Secondary ID [2]
0
0
5475-007
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
0
0
Query!
Hypertension, Pulmonary
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Cardiovascular
0
0
0
0
Query!
Hypertension
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Frespaciguat
Treatment: Drugs - Placebo to Frespaciguat
Experimental: Phase 2 Cohort Frespaciguat 380 µg - Participants receive frespaciguat 380 µg via oral inhalation once daily for 12 week base period and for optional 40 month extension period.
Experimental: Phase 2 Cohort Frespaciguat 100 µg - Participants receive frespaciguat 100 µg via oral inhalation once daily for 12 week base period and for optional 40 month extension period.
Experimental: Phase 2 Cohort Frespaciguat 32 µg - Participants receive frespaciguat 32 µg via oral inhalation once daily for 12 week base period and for optional 40 month extension period.
Placebo comparator: Phase 2 Cohort Placebo - Participants receive placebo via oral inhalation once daily for 12 week base period, and one of the MK-5475 doses (380, 100, or 32 µg) for the optional 40 month extension period.
Experimental: Phase 3 Cohort Frespaciguat - Participants receive one of 3 frespaciguat doses (380, 100 or 32 µg) to be selected at end of the Phase 2 Cohort, administered via oral inhalation once daily for 12-week base period and up to 40 months in the extension period
Placebo comparator: Phase 3 Cohort Placebo - Participants receive placebo via oral inhalation once daily for 12 week base period and up to 40 months in the extension period.
Treatment: Drugs: Frespaciguat
Frespaciguat (soluble guanylate cyclase stimulator) 380 µg, 100 µg or 32 µg administered as dry powder inhalation
Treatment: Drugs: Placebo to Frespaciguat
Placebo administered as dry powder inhalation
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Phase 2 Cohort: Mean Percent Change From Baseline in Pulmonary Vascular Resistance (PVR) at 12 Weeks
Query!
Assessment method [1]
0
0
PVR was calculated in participants after MK-5475 dosing at baseline and Week 12. PVR is assessed by right heart catheterization (RHC). Based on the variables obtained by right heart catheterization (RHC), the percentage change from baseline PVR was calculated. Per protocol, this outcome measure was assessed only for base period and was not assessed during extension period.
Query!
Timepoint [1]
0
0
At baseline and 12 weeks
Query!
Primary outcome [2]
0
0
Phase 3 Cohort: Mean Change From Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks
Query!
Assessment method [2]
0
0
6MWD is measured by an exercise test known as 6-Minute Walk Test (6MWT) that assesses functional capacity. It measures the distance covered over a time of 6 minutes and is intended to be used as an outcome measure by which to compare changes in excercise capacity. Each participant's 6MWD is to be measured at baseline and at 12 weeks. An increase in the distance walked during the 6MWT indicates improvement in functional exercise capacity.
Query!
Timepoint [2]
0
0
At baseline and 12 weeks
Query!
Secondary outcome [1]
0
0
Phase 2 Cohort: Mean Change From Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks
Query!
Assessment method [1]
0
0
6MWD is measured by an exercise test known as 6-Minute Walk Test (6MWT) that assesses functional capacity. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in exercise capacity. Each participant's 6MWD was measured at baseline and at 12 weeks. An increase in the distance walked during the 6MWT indicates improvement in functional exercise capacity.
Query!
Timepoint [1]
0
0
At baseline and 12 weeks
Query!
Secondary outcome [2]
0
0
Phase 2 Cohort: Mean Change From Baseline in Mean Right Atrial Pressure (mRAP) at 12 Weeks
Query!
Assessment method [2]
0
0
mRAP is the blood pressure in the right atrium of the heart. mRAP was assessed by right heart catheterization (RHC).A decrease in mRAP indicates improvement in right ventricular function, reduction of PAH related morbidity.
Query!
Timepoint [2]
0
0
At baseline and 12 weeks
Query!
Secondary outcome [3]
0
0
Phase 2 Cohort: Mean Change From Baseline in Cardiac Index (CI) at 12 Weeks
Query!
Assessment method [3]
0
0
The cardiac index (CI) is a hemodynamic measure that represents the cardiac output (CO) of an individual divided by their body surface area (BSA). Cardiac index is assessed by right heart catheterization (RHC). An increase in CI is indicates better right ventricular function and is associated with a reduction of PAH related morbidity and mortality.
Query!
Timepoint [3]
0
0
At baseline and 12 weeks
Query!
Secondary outcome [4]
0
0
Phase 2 Cohort: Mean Change From Baseline in Stroke Volume Index (SVI) at 12 Weeks
Query!
Assessment method [4]
0
0
The stroke volume index represents the amount of blood in mL, per square meter of body surface area, that is mobilized with each heart beat. SVI is assessed by RHC. An increase in SVI indicates better right ventricular function and is associated with a reduction of PAH related morbidity and mortality.
Query!
Timepoint [4]
0
0
At baseline and 12 weeks
Query!
Secondary outcome [5]
0
0
Phase 3 Cohort: Mean Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks
Query!
Assessment method [5]
0
0
6MWD is measured by an exercise test known as 6-Minute Walk Test (6MWT) that assesses functional capacity. It measures the distance covered over a time of 6 minutes and is intended to be used as an outcome measure by which to compare changes in exercise capacity. Each participant's 6MWD is to be measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicates improvement in functional exercise capacity.
Query!
Timepoint [5]
0
0
At baseline and 24 weeks
Query!
Secondary outcome [6]
0
0
Phase 3 Cohort: Proportion of Participants Whose World Health Organization Functional Class (WHO-FC) is Not Worse at 12 Week Relative to Baseline
Query!
Assessment method [6]
0
0
The World Health Organization (WHO) classification of functional status is a measure of disease severity, based on a patient's description of their level of functioning and symptoms of disease in relation to their everyday activity. Patients were to be assigned 1 of 4 WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity were to increase.
Query!
Timepoint [6]
0
0
At baseline and 12 weeks
Query!
Secondary outcome [7]
0
0
Phase 2 Cohort: Number of Participants Who Experienced an Adverse Event
Query!
Assessment method [7]
0
0
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Query!
Timepoint [7]
0
0
Up to approximately 2.25 years
Query!
Secondary outcome [8]
0
0
Phase 2 Cohort: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Query!
Assessment method [8]
0
0
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.
Query!
Timepoint [8]
0
0
Up to approximately 2.25 years
Query!
Secondary outcome [9]
0
0
Phase 3 Cohort: Number of Participants Who Experienced an Adverse Event
Query!
Assessment method [9]
0
0
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Query!
Timepoint [9]
0
0
Up to approximately 2.25 years
Query!
Secondary outcome [10]
0
0
Phase 3 Cohort: Number of Participants Who Discontinued Study Drug Due to an AE
Query!
Assessment method [10]
0
0
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.
Query!
Timepoint [10]
0
0
Up to approximately 2.25 years
Query!
Eligibility
Key inclusion criteria
* Pulmonary arterial hypertension (PAH) in one of the following groups:
* Idiopathic PAH
* Heritable PAH
* Drug and toxin-induced PAH
* PAH associated with connective tissue disease, HIV infection, or congenital heart disease.
* Diagnosis of PAH documented by right heart catheterization (RHC).
* Eligibility RHC meeting all of the following criteria:
* Mean pulmonary artery pressure (mPAP) =25 mmHg
* Pulmonary vascular resistance (PVR) of =3 Wood units
* Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) =15 mmHg.
* World Health Organization functional class (WHO-FC) symptoms between Class II and IV.
* Two 6-Minute walk distance (6MWD) measurements between 150 and 500 meters, one at screening and one at randomization.
* Stable concomitant background PAH-specific therapy.
* Body Mass Index (BMI) between 18.5 kg/m² and 40 kg/m² .
* Agree to be abstinent from heterosexual intercourse or use contraception during the intervention period and for at least 14 days after the last dose of study intervention.
* Female participants may not be pregnant or breastfeeding.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Group 2 to 5 pulmonary hypertension.
* PAH in one of the following groups:
* Long term responders to calcium channel blockers
* Overt features of venous/capillary involvement
* Evidence of more-than-mild obstructive lung disease.
* Evidence of more-than-mild parenchymal lung disease.
* Evidence of more-than-mild obstructive sleep apnea (OSA) that is untreated.
* Evidence or history of left heart disease, including any of the following:
* Left ventricular ejection fraction (LVEF) =45%
* Moderate or severe left-sided valvular disease (aortic or mitral valve stenosis or regurgitation)
* Significant left ventricular diastolic dysfunction on echocardiographic evaluation
* Presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction: BMI>30 kg/m², essential systemic hypertension, diabetes mellitus of any type, or coronary artery disease.
* Oxygen saturation measured by pulse oximetry (SpO2) <90%, despite supplemental oxygen therapy.
* Chronic renal insufficiency (eGFR <30 mL/min)
* Chronic liver disease (i.e., Child-Pugh B or C), portal hypertension, cirrhosis, or significant hepatic laboratory abnormalities.
* Current smoker or currently uses electronic cigarettes (vapes).
* History of cancer, except: nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated, with appropriate follow up, and unlikely to recur for the duration of the study.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
19/05/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
2/07/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
168
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Nepean Hospital ( Site 0184) - Kingswood
Query!
Recruitment hospital [2]
0
0
Macquarie University ( Site 0180) - Macquarie University
Query!
Recruitment hospital [3]
0
0
John Hunter Hospital ( Site 0185) - Newcastle
Query!
Recruitment postcode(s) [1]
0
0
2747 - Kingswood
Query!
Recruitment postcode(s) [2]
0
0
2109 - Macquarie University
Query!
Recruitment postcode(s) [3]
0
0
2305 - Newcastle
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Indiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Iowa
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Missouri
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Nebraska
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New Mexico
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
North Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
South Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Tennessee
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Texas
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Virginia
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
West Virginia
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
Buenos Aires
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
Caba
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Santa Fe
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Cordoba
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Bruxelles-Capitale, Region De
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Vlaams-Brabant
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Alberta
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Ontario
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Quebec
Query!
Country [28]
0
0
Colombia
Query!
State/province [28]
0
0
Antioquia
Query!
Country [29]
0
0
Colombia
Query!
State/province [29]
0
0
Distrito Capital De Bogota
Query!
Country [30]
0
0
Colombia
Query!
State/province [30]
0
0
Santander
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Finistere
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Haute-Garonne
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Nord-Pas-de-Calais
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Seine-Maritime
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Val-de-Marne
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Baden-Wurttemberg
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Bayern
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Hessen
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Niedersachsen
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Sachsen
Query!
Country [41]
0
0
Greece
Query!
State/province [41]
0
0
Thessaloniki
Query!
Country [42]
0
0
Israel
Query!
State/province [42]
0
0
Beer Sheva
Query!
Country [43]
0
0
Israel
Query!
State/province [43]
0
0
Haifa
Query!
Country [44]
0
0
Israel
Query!
State/province [44]
0
0
Holon
Query!
Country [45]
0
0
Israel
Query!
State/province [45]
0
0
Jerusalem
Query!
Country [46]
0
0
Israel
Query!
State/province [46]
0
0
Petah Tikva
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Campania
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Lazio
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Monza E Brianza
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Milano
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Pavia
Query!
Country [52]
0
0
Mexico
Query!
State/province [52]
0
0
Veracruz
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Huixquilucan
Query!
Country [54]
0
0
Mexico
Query!
State/province [54]
0
0
Mexico D.F
Query!
Country [55]
0
0
New Zealand
Query!
State/province [55]
0
0
Canterbury
Query!
Country [56]
0
0
New Zealand
Query!
State/province [56]
0
0
Auckland
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Dolnoslaskie
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Lubelskie
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Malopolskie
Query!
Country [60]
0
0
Russian Federation
Query!
State/province [60]
0
0
Kemerovskaya Oblast
Query!
Country [61]
0
0
Russian Federation
Query!
State/province [61]
0
0
Sankt-Peterburg
Query!
Country [62]
0
0
Sweden
Query!
State/province [62]
0
0
Uppsala Lan
Query!
Country [63]
0
0
Sweden
Query!
State/province [63]
0
0
Vastra Gotalands Lan
Query!
Country [64]
0
0
Turkey
Query!
State/province [64]
0
0
Izmir
Query!
Country [65]
0
0
Turkey
Query!
State/province [65]
0
0
Ankara
Query!
Country [66]
0
0
Turkey
Query!
State/province [66]
0
0
Antalya
Query!
Country [67]
0
0
Turkey
Query!
State/province [67]
0
0
Eskisehir
Query!
Country [68]
0
0
Turkey
Query!
State/province [68]
0
0
Istanbul
Query!
Country [69]
0
0
United Kingdom
Query!
State/province [69]
0
0
Glasgow City
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
London, City Of
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
Newcastle Upon Tyne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Merck Sharp & Dohme LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a two-part (Phase 2/Phase 3) study of frespaciguat, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH). The first part (Phase 2) will assess three different doses of frespaciguat compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of frespaciguat during an optional 40 month extension period. The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selected for use in the second part (Phase 3) of the study. The primary hypothesis of Phase 2 is that at least one frespaciguat dose is superior to placebo in reducing pulmonary vascular resistance (PVR) from baseline at week 12. The purpose of the second part (Phase 3) of the study is to confirm the efficacy, safety, and tolerability of frespaciguat at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years. The primary hypothesis of Phase 3 is that frespaciguat is superior to placebo in increasing 6-minute walk distance (6MWD) from baseline at week 12. Due to sponsor's decision this phase/part was not conducted.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04732221
Query!
Trial related presentations / publications
Humbert M, Hassoun PM, Chin KM, Bortman G, Patel MJ, La Rosa C, Fu W, Loureiro MJ, Hoeper MM. MK-5475, an inhaled soluble guanylate cyclase stimulator, for treatment of pulmonary arterial hypertension: the INSIGNIA-PAH study. Eur Respir J. 2024 Nov 14;64(5):2401110. doi: 10.1183/13993003.01110-2024. Print 2024 Nov.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Merck Sharp & Dohme LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/21/NCT04732221/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/21/NCT04732221/Prot_SAP_000.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Humbert M, Hassoun PM, Chin KM, Bortman G, Patel M...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT04732221
Download to PDF