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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04583423




Registration number
NCT04583423
Ethics application status
Date submitted
5/10/2020
Date registered
12/10/2020

Titles & IDs
Public title
A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
Scientific title
A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.
Secondary ID [1] 0 0
MK-3655-001
Secondary ID [2] 0 0
3655-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MK-3655
Treatment: Drugs - Placebo

Experimental: MK-3655 50 mg - Following a 2-week placebo run-in, participants will receive MK-3655 50 mg by subcutaneous (SC) injection once every 4 weeks (Q4W) for 52 weeks.

Experimental: MK-3655 100 mg - Following a 2-week placebo run-in, participants will receive MK-3655 100 mg by SC injection Q4W for 52 weeks.

Experimental: MK-3655 300 mg - Following a 2-week placebo run-in, participants will receive MK-3655 300 mg by SC injection Q4W for 52 weeks.

Placebo comparator: Placebo - Following a 2-week placebo run-in, participants will receive Placebo by SC injection Q4W for 52 weeks.


Treatment: Drugs: MK-3655
MK-3655 50, 100 or 300 dose for injection

Treatment: Drugs: Placebo
Matching placebo to MK-3655
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 52 Weeks
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Percentage of Participants Who Experienced an Adverse Event (AE)
Timepoint [2] 0 0
Up to 64 weeks
Primary outcome [3] 0 0
Percentage of Participants Discontinuing Study Medication Due to an AE
Timepoint [3] 0 0
Up to 52 weeks
Secondary outcome [1] 0 0
Mean Percent Relative Reduction From Baseline in Liver Fat Content (LFC) After 24 Weeks
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Percentage of Participants With =1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis Assessed With the NASH CRN Scoring System After 52 Weeks
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of Participants With =2 Point Improvement in NAS With =1 Point Improvement in Inflammation or Ballooning Without Worsening of Fbrosis by Histology (Evaluated by BICR) After 52 Weeks
Timepoint [3] 0 0
Week 52

Eligibility
Key inclusion criteria
* Has histological confirmation of NASH
* Is a male or female aged 18 years to 80 years (in Japan and Taiwan aged 20 to 80 years)
* Has a body mass index (BMI) =25 kg/m^2 and =50 kg/m^2 and stable weight for the past 3 months
* Has no history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM controlled by diet or stable doses of antihyperglycemic agents (AHAs)
* Contraceptive use by male participants should be consistent with local regulations.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and she is not a woman of child-bearing potential (WOCBP) OR she is a WOCBP and uses a contraceptive method that is highly effective during the intervention period and for at least 16 weeks after the last dose of study intervention.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Has presence of cirrhosis on liver biopsy
* Has Type 1 diabetes
* Has a history of malignancy, unless cancer free =5 years, or is under evaluation for active or suspected malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Has a history of bariatric surgery =5 years before study participation
* Has undergone a major surgical procedure =3 months before study participation or has major surgery planned during the study
* Has a history or evidence of chronic liver disease other than NASH. Individuals with a history of Hepatitis B or C may be eligible for participation.
* Has significant systemic or major illnesses other than liver disease, including recent events (=6 months before study entry) of congestive heart failure, unstable coronary artery disease, arterial revascularization, pulmonary disease, renal failure, stroke, transient ischemic attack, or organ transplantation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/04/2023
Sample size
Target
Accrual to date
Final
183
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital ( Site 0102) - Camperdown
Recruitment hospital [2] 0 0
St George Hospital ( Site 0104) - Kogarah
Recruitment hospital [3] 0 0
Flinders Medical Centre ( Site 0107) - Bedford Park
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
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California
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United States of America
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Colorado
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Florida
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United States of America
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Georgia
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United States of America
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Iowa
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United States of America
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Louisiana
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United States of America
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Mississippi
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United States of America
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Missouri
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Nevada
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New York
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Pennsylvania
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Santa Fe
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Biobio
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Chile
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Coquimbo
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Chile
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Los Rios
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Chile
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Region M. De Santiago
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Chile
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Valparaiso
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China
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Beijing
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China
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Chongqing
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China
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Guangdong
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China
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Ningxia
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China
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Shanghai
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China
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Zhejiang
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Colombia
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Distrito Capital De Bogota
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France
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Alpes-Maritimes
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France
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Aquitaine
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France
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Auvergne
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France
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Bourgogne
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France
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Franche-Comte
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France
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Haute-Vienne
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France
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Hauts-de-Seine
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France
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Meurthe-et-Moselle
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France
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Nord
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France
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Val-de-Marne
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France
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Paris
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Germany
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Baden-Wurttemberg
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Germany
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Hessen
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Germany
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Rheinland-Pfalz
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Germany
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Sachsen
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Germany
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Berlin
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Greece
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Kentriki Makedonia
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Ramat Hasharon
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Israel
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Tel Aviv
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Italy
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Lombardia
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Italy
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Modena
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Italy
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Roma
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Italy
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Verona
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Japan
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Aichi
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Ehime
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Gifu
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Hokkaido
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Ishikawa
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Japan
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Kagawa
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Japan
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Kanagawa
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Japan
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Nara
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Japan
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Osaka
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Japan
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Fukui
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Japan
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Hiroshima
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Japan
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Kagoshima
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Japan
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Kyoto
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Japan
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Okayama
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Japan
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Tokyo
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Pusan-Kwangyokshi
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Korea, Republic of
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Seoul
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Korea, Republic of
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Incheon
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Malaysia
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Kuala Lumpur
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Mexico
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Distrito Federal
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Jalisco
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Mexico City
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New Zealand
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Canterbury
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Auckland
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Puerto Rico
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Rio Piedras
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Puerto Rico
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San Juan
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Russian Federation
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Moskva
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Russian Federation
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Sankt-Peterburg
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Spain
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Cantabria
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Spain
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La Coruna
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Barcelona
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Sweden
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Stockholms Lan
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Sweden
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Uppsala Lan
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Taiwan
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Chiayi
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Taiwan
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Taichung
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Taiwan
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Taoyuan
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Taiwan
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Turkey
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Ankara
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Turkey
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Istanbul
Country [109] 0 0
Turkey
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Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director, MD
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04583423