ACT-293987 in Pulmonary Arterial Hypertension

NCT ID: NCT01112306

Last Updated: 2025-03-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

709 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-07

Study Completion Date

2021-08-26

Brief Summary

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Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

ACT-293987, twice daily

Group Type EXPERIMENTAL

ACT-293987

Intervention Type DRUG

Tablets, twice daily

Interventions

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ACT-293987

Tablets, twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who participated to the double-blind study AC-065A302 and either had a morbidity event or had completed the study as scheduled per protocol.
* Signed informed consent.

Exclusion Criteria

* Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in AC-065A302/GRIPHON.
* Severe hepatic impairment (Child-Pugh C).
* Females who are pregnant or who plan to become pregnant during the study, or are breastfeeding.
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence, or psychiatric disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aline Frey

Role: STUDY_DIRECTOR

Actelion

Locations

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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Torrance, California, United States

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Newark, Delaware, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Austell, Georgia, United States

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Carmel, Indiana, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Troy, Michigan, United States

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Rochester, Minnesota, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Newark, New Jersey, United States

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Islandia, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Bend, Oregon, United States

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Portland, Oregon, United States

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Doylestown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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York, Pennsylvania, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Adelaide, , Australia

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Bedford Park, , Australia

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Chermside, , Australia

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Concord, , Australia

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Darlinghurst, , Australia

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Fitzroy, , Australia

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Hobart, , Australia

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Murdoch, , Australia

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New Lambton, , Australia

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Parkville, , Australia

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Graz, , Austria

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Vienna, , Austria

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Minsk, , Belarus

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Brussels, , Belgium

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Leuven, , Belgium

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Santiago, , Chile

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Beijing, , China

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Guangzhou, , China

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Shanghai, , China

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Bogotá, , Colombia

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Prague, , Czechia

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Aarhus, , Denmark

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Copenhagen, , Denmark

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Bron, , France

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Le Kremlin-Bicêtre, , France

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Lille, , France

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Toulouse, , France

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Berlin, , Germany

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Cologne, , Germany

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Dresden, , Germany

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Giessen, , Germany

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Greifswald, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Leipzig, , Germany

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Löwenstein, , Germany

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Regensburg, , Germany

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Alexandroupoli, , Greece

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Athens, , Greece

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Thessaloniki, , Greece

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Budapest, , Hungary

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Debrecen, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Ahmedabad, , India

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Chennai, , India

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Hyderabad, , India

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Dublin, , Ireland

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Haifa, , Israel

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Jerusalem, , Israel

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Petah Tikva, , Israel

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Rehovot, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Kuala Lumpur, , Malaysia

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Mexico City, , Mexico

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Amsterdam, , Netherlands

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Maastricht, , Netherlands

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Rotterdam, , Netherlands

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Lima, , Peru

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Gdansk, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Otwock, , Poland

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Bucharest, , Romania

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Iași, , Romania

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Barnaul, , Russia

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Kemerovo, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Tomsk, , Russia

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Yekaterinburg, , Russia

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Belgrade, , Serbia

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Singapore, , Singapore

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Bratislava, , Slovakia

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Košice, , Slovakia

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Incheon, , South Korea

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Seoul, , South Korea

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Barcelona, , Spain

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Madrid, , Spain

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Gothenburg, , Sweden

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Linköping, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Basel, , Switzerland

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Bern, , Switzerland

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Geneva, , Switzerland

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Lausanne, , Switzerland

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Kaohsiung City, , Taiwan

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Taipei, , Taiwan

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Khon Kaen, , Thailand

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Adana, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Dnipro, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Glasgow, , United Kingdom

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London, , United Kingdom

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Countries

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United States Argentina Australia Austria Belarus Belgium Canada Chile China Colombia Czechia Denmark France Germany Greece Hungary India Ireland Israel Malaysia Mexico Netherlands Peru Poland Romania Russia Serbia Singapore Slovakia South Korea Spain Sweden Switzerland Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom

References

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Galie N, Gaine S, Channick R, Coghlan JG, Hoeper MM, Lang IM, McLaughlin VV, Lassen C, Rubin LJ, Hsu Schmitz SF, Sitbon O, Tapson VF, Chin KM. Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. Adv Ther. 2022 Jan;39(1):796-810. doi: 10.1007/s12325-021-01898-1. Epub 2021 Oct 30.

Reference Type DERIVED
PMID: 34727317 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2009-014992-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AC-065A303

Identifier Type: -

Identifier Source: org_study_id

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