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
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04796337
Registration number
NCT04796337
Ethics application status
Date submitted
22/02/2021
Date registered
12/03/2021
Titles & IDs
Public title
A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)
Query!
Scientific title
An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
Query!
Secondary ID [1]
0
0
A011-12
Query!
Secondary ID [2]
0
0
7962-004
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SOTERIA
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
0
0
Query!
PAH
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: Other - Sotatercept
Experimental: Sotatercept Treatment - Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg SC for Visit 1. Dose will escalate to 0.7 mg/kg SC at Visit 2 through remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and if at dose \< 0.7 mg/kg SC can titrate up to 0.7 mg/kg SC for the remainder of the study.
Treatment: Other: Sotatercept
Sotatercept subcutaneous injection at a dose of 0.3 to 0.7 mg/kg.
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants Who Experience an Adverse Event (AE)
Query!
Assessment method [1]
0
0
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who experience an AE will be reported.
Query!
Timepoint [1]
0
0
Up to approximately 50 months
Query!
Primary outcome [2]
0
0
Number of Participants Who Discontinue Study Treatment Due to an AE
Query!
Assessment method [2]
0
0
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Query!
Timepoint [2]
0
0
Up to approximately 50 months
Query!
Primary outcome [3]
0
0
Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
Query!
Assessment method [3]
0
0
ADAs will be detected in serum. The number of participants with detectable ADAs will be presented.
Query!
Timepoint [3]
0
0
Up to approximately 50 months
Query!
Primary outcome [4]
0
0
Laboratory parameters (Hematology): Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin and Hematocrit
Query!
Assessment method [4]
0
0
Blood samples will be collected to determine concentration of red blood cell count, white blood cell count, platelet count, hemoglobin and hematocrit at designated timepoints up to approximately 50 months.
Query!
Timepoint [4]
0
0
Up to approximately 50 months
Query!
Primary outcome [5]
0
0
Laboratory parameters (Serum Chemistry): Concentration of Blood Urea, Creatinine, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, Magnesium, Carbon Dioxide, and Albumin
Query!
Assessment method [5]
0
0
Blood samples will be collected to determine concentration of blood urea, creatinine, total bilirubin, direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP, sodium, potassium, chloride, calcium, phosphorous, glucose, magnesium, carbon dioxide, and albumin at designated time points for up to approximately 50 months.
Query!
Timepoint [5]
0
0
Up to approximately 50 months
Query!
Primary outcome [6]
0
0
Laboratory parameter: Concentration of Follicle Stimulating Hormone (FSH)
Query!
Assessment method [6]
0
0
Blood samples will be collected to determine concentration of FSH level at designated time points up to approximately 50 months.
Query!
Timepoint [6]
0
0
Up to approximately 50 months
Query!
Primary outcome [7]
0
0
Change From Baseline in Body Weight
Query!
Assessment method [7]
0
0
Change from baseline in body weight will be reported at designated time points up to approximately 48 months.
Query!
Timepoint [7]
0
0
Baseline and up to approximately 48 months
Query!
Primary outcome [8]
0
0
Change From Baseline in Blood Pressure
Query!
Assessment method [8]
0
0
Change from baseline in systolic and diastolic blood pressure will be reported at designated time points up to approximately 48 months.
Query!
Timepoint [8]
0
0
Baseline and up to approximately 48 months
Query!
Primary outcome [9]
0
0
Change From Baseline in Electrocardiogram (ECG)
Query!
Assessment method [9]
0
0
Change from baseline in ECG (12-lead) for the determination of QTcF interval will be reported at designated time points up to approximately 48 months.
Query!
Timepoint [9]
0
0
Baseline and up to approximately 48 months
Query!
Primary outcome [10]
0
0
Laboratory parameters (Urinalysis): pH, Specific Gravity, Protein, Glucose, Bilirubin, Ketones, Blood, Leukocyte Esterase, Urobilinogen, and Nitrite
Query!
Assessment method [10]
0
0
Urine samples will be collected to determine pH, specific gravity, protein, glucose, bilirubin, ketones, blood, leukocyte esterase, urobilinogen, and nitrite at designated timepoints up to approximately 48 months.
Query!
Timepoint [10]
0
0
Up to approximately 48 months
Query!
Secondary outcome [1]
0
0
Change From Baseline in 6-Minute Walk Distance (6MWD)
Query!
Assessment method [1]
0
0
The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). The change from baseline in 6MWD will be reported.
Query!
Timepoint [1]
0
0
Baseline and up to approximately 48 months
Query!
Secondary outcome [2]
0
0
Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels
Query!
Assessment method [2]
0
0
NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP level will be reported.
Query!
Timepoint [2]
0
0
Baseline and up to approximately 48 months
Query!
Secondary outcome [3]
0
0
Change From Baseline in the Percentage of Participants Who Improve in modified New York Heart Association (NYHA)/ World Health Organization classification of functional status (WHO FC)
Query!
Assessment method [3]
0
0
The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. The change from baseline in the percentage of participants who improve in WHO FC will be reported.
Query!
Timepoint [3]
0
0
Baseline and up to approximately 48 months
Query!
Secondary outcome [4]
0
0
Change From Baseline in Pulmonary Vascular Resistance (PVR)
Query!
Assessment method [4]
0
0
PVR is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization (RHC). The change from baseline in PVR will be reported.
Query!
Timepoint [4]
0
0
Baseline and up to approximately 48 months
Query!
Secondary outcome [5]
0
0
Overall Survival (OS)
Query!
Assessment method [5]
0
0
Overall survival is defined as the time from the start of the first sotatercept treatment in the individual participant's parent study or in this study, if the participant was completely on placebo in the parent study, to the date of death in this study, regardless of the actual cause of the participant's death.
Query!
Timepoint [5]
0
0
Up to approximately 78 months
Query!
Secondary outcome [6]
0
0
Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator
Query!
Assessment method [6]
0
0
The simplified French risk scoring system was based on the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for the diagnosis and treatment of pulmonary hypertension (PH). In this study, the noninvasive parameters were used to determine the score. 'Low risk' was defined as attaining or maintaining all 3 low-risk criteria: WHO FC I or II, 6MWD \> 440 m, and NT-proBNP \<300 ng/L. The change from baseline in percentage of participants who maintained or achieved a low risk score using the simplified French risk score calculator will be reported.
Query!
Timepoint [6]
0
0
Baseline and up to approximately 48 months
Query!
Secondary outcome [7]
0
0
Change From Baseline in Borg Dyspnea Scale Category Ratio 10 (Borg CR 10) Score
Query!
Assessment method [7]
0
0
The Borg CR 10 Scale assesses the severity of shortness of breath as perceived by the participant. Participants will be asked: How much difficulty is your breathing causing you right now?". The score of the item ranges from 0 (no difficulty in breathing) to10 (maximum difficulty in breathing). Higher score indicates more severe dyspnea. The change from baseline in Borg CR10 scale score will be reported.
Query!
Timepoint [7]
0
0
Baseline and up to approximately 48 months
Query!
Eligibility
Key inclusion criteria
* Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
* Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements
* Must have the ability to understand and provide documented informed consent
* Females of childbearing potential must:
* Have a negative pregnancy test as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
* If sexually active, have used, and agree to continue to use highly effective contraception in combination with a barrier method without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug
* Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug
* Male participants must:
* Agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
* Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug
* Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Did not participate in a sotatercept PAH parent trial
* Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
* Presence of an ongoing serious adverse event (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
* Pregnant or breastfeeding females
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
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
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
12/05/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/11/2027
Query!
Actual
Query!
Sample size
Target
700
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital ( Site 1106) - Camperdown
Query!
Recruitment hospital [2]
0
0
Saint Vincents Hospital Sydney ( Site 1102) - Darlinghurst
Query!
Recruitment hospital [3]
0
0
John Hunter Hospital ( Site 1101) - New Lambton
Query!
Recruitment hospital [4]
0
0
The Prince Charles Hospital ( Site 1104) - Brisbane
Query!
Recruitment hospital [5]
0
0
Princess Alexandra Hospital ( Site 1108) - Woolloongabba
Query!
Recruitment hospital [6]
0
0
Royal Adelaide Hospital ( Site 1109) - Adelaide
Query!
Recruitment hospital [7]
0
0
Royal Hobart Hospital ( Site 1107) - Hobart
Query!
Recruitment hospital [8]
0
0
Fiona Stanley Hospital ( Site 1103) - Perth
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [3]
0
0
2305 - New Lambton
Query!
Recruitment postcode(s) [4]
0
0
4032 - Brisbane
Query!
Recruitment postcode(s) [5]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [6]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [7]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [8]
0
0
6150 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Iowa
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
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nebraska
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nevada
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Mexico
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Ohio
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oklahoma
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oregon
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Rhode Island
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
South Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Tennessee
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Texas
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Utah
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Washington
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Wisconsin
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Buenos Aires
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Caba
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Cordoba
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Santa Fe
Query!
Country [34]
0
0
Austria
Query!
State/province [34]
0
0
Oberosterreich
Query!
Country [35]
0
0
Austria
Query!
State/province [35]
0
0
Steiermark
Query!
Country [36]
0
0
Austria
Query!
State/province [36]
0
0
Tirol
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Wien
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Bruxelles-Capitale, Region De
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Vlaams-Brabant
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
Minas Gerais
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Rio Grande Do Sul
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Santa Catarina
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Sao Paulo
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Alberta
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Manitoba
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Ontario
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Quebec
Query!
Country [48]
0
0
Colombia
Query!
State/province [48]
0
0
Antioquia
Query!
Country [49]
0
0
Colombia
Query!
State/province [49]
0
0
Cundinamarca
Query!
Country [50]
0
0
Colombia
Query!
State/province [50]
0
0
Valle Del Cauca
Query!
Country [51]
0
0
Croatia
Query!
State/province [51]
0
0
Splitsko-dalmatinska Zupanija
Query!
Country [52]
0
0
Croatia
Query!
State/province [52]
0
0
Zagrebacka Zupanija
Query!
Country [53]
0
0
Czechia
Query!
State/province [53]
0
0
Praha 2
Query!
Country [54]
0
0
Czechia
Query!
State/province [54]
0
0
Praha 4
Query!
Country [55]
0
0
Denmark
Query!
State/province [55]
0
0
Hovedstaden
Query!
Country [56]
0
0
Denmark
Query!
State/province [56]
0
0
Midtjylland
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Alpes-Maritimes
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Bas-Rhin
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Calvados
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Finistere
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Gironde
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Haute-Garonne
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Herault
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Indre-et-Loire
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Isere
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Loire-Atlantique
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Loire
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Maine-et-Loire
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Meurthe-et-Moselle
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Nord
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Rhone-Alpes
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Val-de-Marne
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Vienne
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Baden-Wurttemberg
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Bayern
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Hessen
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Niedersachsen
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Nordrhein-Westfalen
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Saarland
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Sachsen-Anhalt
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Sachsen
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Berlin
Query!
Country [83]
0
0
Greece
Query!
State/province [83]
0
0
Attiki
Query!
Country [84]
0
0
Greece
Query!
State/province [84]
0
0
Thessaloniki
Query!
Country [85]
0
0
Israel
Query!
State/province [85]
0
0
Ashdod
Query!
Country [86]
0
0
Israel
Query!
State/province [86]
0
0
Ashkelon
Query!
Country [87]
0
0
Israel
Query!
State/province [87]
0
0
Haifa
Query!
Country [88]
0
0
Israel
Query!
State/province [88]
0
0
Jerusalem
Query!
Country [89]
0
0
Israel
Query!
State/province [89]
0
0
Kfar Saba
Query!
Country [90]
0
0
Israel
Query!
State/province [90]
0
0
Petach Tikvah
Query!
Country [91]
0
0
Israel
Query!
State/province [91]
0
0
Ramat Gan
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Friuli-Venezia Giulia
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Lombardia
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Napoli
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
Roma
Query!
Country [96]
0
0
Korea, Republic of
Query!
State/province [96]
0
0
Kyonggi-do
Query!
Country [97]
0
0
Korea, Republic of
Query!
State/province [97]
0
0
Incheon
Query!
Country [98]
0
0
Korea, Republic of
Query!
State/province [98]
0
0
Seoul
Query!
Country [99]
0
0
Mexico
Query!
State/province [99]
0
0
Distrito Federal
Query!
Country [100]
0
0
Mexico
Query!
State/province [100]
0
0
Nuevo Leon
Query!
Country [101]
0
0
Mexico
Query!
State/province [101]
0
0
Huixquilucan
Query!
Country [102]
0
0
Netherlands
Query!
State/province [102]
0
0
Gelderland
Query!
Country [103]
0
0
Netherlands
Query!
State/province [103]
0
0
Limburg
Query!
Country [104]
0
0
Netherlands
Query!
State/province [104]
0
0
Noord-Holland
Query!
Country [105]
0
0
Netherlands
Query!
State/province [105]
0
0
Zuid-Holland
Query!
Country [106]
0
0
New Zealand
Query!
State/province [106]
0
0
Waikato
Query!
Country [107]
0
0
New Zealand
Query!
State/province [107]
0
0
Auckland
Query!
Country [108]
0
0
Poland
Query!
State/province [108]
0
0
Malopolskie
Query!
Country [109]
0
0
Poland
Query!
State/province [109]
0
0
Mazowieckie
Query!
Country [110]
0
0
Portugal
Query!
State/province [110]
0
0
Setubal
Query!
Country [111]
0
0
Portugal
Query!
State/province [111]
0
0
Coimbra
Query!
Country [112]
0
0
Portugal
Query!
State/province [112]
0
0
Lisboa
Query!
Country [113]
0
0
Serbia
Query!
State/province [113]
0
0
Juznobacki Okrug
Query!
Country [114]
0
0
Serbia
Query!
State/province [114]
0
0
Nisavski Okrug
Query!
Country [115]
0
0
Serbia
Query!
State/province [115]
0
0
Sumadijski Okrug
Query!
Country [116]
0
0
Serbia
Query!
State/province [116]
0
0
Beograd
Query!
Country [117]
0
0
Spain
Query!
State/province [117]
0
0
Cantabria
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Islas Baleares
Query!
Country [119]
0
0
Spain
Query!
State/province [119]
0
0
Madrid
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
Barcelona
Query!
Country [121]
0
0
Spain
Query!
State/province [121]
0
0
Salamanca
Query!
Country [122]
0
0
Spain
Query!
State/province [122]
0
0
Toledo
Query!
Country [123]
0
0
Sweden
Query!
State/province [123]
0
0
Skane Lan
Query!
Country [124]
0
0
Sweden
Query!
State/province [124]
0
0
Uppsala Lan
Query!
Country [125]
0
0
Sweden
Query!
State/province [125]
0
0
Vasterbottens Lan
Query!
Country [126]
0
0
Sweden
Query!
State/province [126]
0
0
Vastra Gotalands Lan
Query!
Country [127]
0
0
Switzerland
Query!
State/province [127]
0
0
Zurich
Query!
Country [128]
0
0
Taiwan
Query!
State/province [128]
0
0
Kaohsiung
Query!
Country [129]
0
0
Taiwan
Query!
State/province [129]
0
0
Taichung
Query!
Country [130]
0
0
Taiwan
Query!
State/province [130]
0
0
Tainan
Query!
Country [131]
0
0
United Kingdom
Query!
State/province [131]
0
0
Cambridgeshire
Query!
Country [132]
0
0
United Kingdom
Query!
State/province [132]
0
0
England
Query!
Country [133]
0
0
United Kingdom
Query!
State/province [133]
0
0
Glasgow City
Query!
Country [134]
0
0
United Kingdom
Query!
State/province [134]
0
0
London, City Of
Query!
Country [135]
0
0
United Kingdom
Query!
State/province [135]
0
0
North Yorkshire
Query!
Country [136]
0
0
United Kingdom
Query!
State/province [136]
0
0
Newcastle Upon Tyne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04796337
Query!
Trial related presentations / publications
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
Toll Free Number
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-888-577-8839
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04796337