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A Long-term Extension Study of PCI-32765 (Ibrutinib)

NCT ID: NCT01804686

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-09

Study Completion Date

2027-01-29

Brief Summary

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The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.

Detailed Description

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This is an open-label (identity of assigned study drug will be known) study designed to collect long-term safety and efficacy data and provide ibrutinib access to participants in completed ibrutinib studies. PCI-32765 (Ibrutinib) is a first-in-class, potent, orally-administered, covalently-binding small molecule inhibitor of bruton's tyrosine kinase. "PCI-32765" and "ibrutinib" refer to the same molecule; hereafter, "ibrutinib" will be used. Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.

Conditions

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Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Diffuse Large B-cell Lymphoma Waldenstrom Macroglobulinemia Chronic Graft Versus Host Disease

Keywords

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Chronic lymphocytic leukemia Small lymphocytic lymphoma Mantle cell lymphoma Follicular lymphoma Diffuse large B-cell lymphoma PCI-32765 Ibrutinib Bruton's tyrosine kinase inhibitor IMBRUVICA JNJ-54179060

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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Ibrutinib

Group Type EXPERIMENTAL

Ibrutinib

Intervention Type DRUG

Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.

Interventions

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Ibrutinib

Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.

Intervention Type DRUG

Other Intervention Names

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PCI-32765

Eligibility Criteria

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Inclusion Criteria

* Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib
* Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
* Agrees to protocol-defined use of effective contraception
* Negative blood or urine pregnancy test at screening

Exclusion Criteria

* Requires anticoagulation with warfarin or equivalent vitamin K antagonists
* Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
* Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmacyclics LLC.

INDUSTRY

Sponsor Role collaborator

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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City of Hope Cancer Center

Duarte, California, United States

Site Status COMPLETED

University of California San Diego Medical Center

La Jolla, California, United States

Site Status COMPLETED

University of California Los Angeles

Los Angeles, California, United States

Site Status COMPLETED

St. Joseph Hospital Center for Cancer Prevention and Treatment

Orange, California, United States

Site Status RECRUITING

Stanford University Medical Center

Stanford, California, United States

Site Status COMPLETED

Stanford University

Stanford, California, United States

Site Status COMPLETED

Norwalk Medical Group

Norwalk, Connecticut, United States

Site Status COMPLETED

Northwest Georgia Oncology Centers PC

Marietta, Georgia, United States

Site Status COMPLETED

Northwestern University Hospital

Chicago, Illinois, United States

Site Status COMPLETED

Indiana University

Goshen, Indiana, United States

Site Status COMPLETED

Kansas University Medical Center

Westwood, Kansas, United States

Site Status COMPLETED

Louisville Oncology Suburban - Norton Cancer Institute

Louisville, Kentucky, United States

Site Status COMPLETED

Dana Farber Cancer Center

Boston, Massachusetts, United States

Site Status COMPLETED

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status COMPLETED

Battle Creek Health Systm

Battle Creek, Michigan, United States

Site Status COMPLETED

Karmanos Cancer Institute - Wayne State University

Detroit, Michigan, United States

Site Status COMPLETED

Washington University

St Louis, Missouri, United States

Site Status COMPLETED

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status COMPLETED

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status COMPLETED

Weill Medical College of Cornell University

New York, New York, United States

Site Status COMPLETED

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status COMPLETED

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States

Site Status COMPLETED

The Ohio State University- James Cancer Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Willamette Valley Cancer Center

Eugene, Oregon, United States

Site Status RECRUITING

Kaiser Permanente

Portland, Oregon, United States

Site Status COMPLETED

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

Site Status COMPLETED

Avera Medical Group

Sioux Falls, South Dakota, United States

Site Status RECRUITING

MD Anderson Cancer Center - University of Texas

Houston, Texas, United States

Site Status COMPLETED

University of Virginia

Charlottesville, Virginia, United States

Site Status COMPLETED

University of Washington

Seattle, Washington, United States

Site Status COMPLETED

West Virginia University

Morgantown, West Virginia, United States

Site Status COMPLETED

University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research

Madison, Wisconsin, United States

Site Status COMPLETED

CEMIC Saavedra

Ciudad Autonoma Buenos Aires, , Argentina

Site Status ACTIVE_NOT_RECRUITING

Fundaleu

Ciudad de Buenos Aires, , Argentina

Site Status COMPLETED

Royal Adelaide Hospital

Adelaide, , Australia

Site Status ACTIVE_NOT_RECRUITING

John Fawkner Cancer Trial Centre

Coburg, , Australia

Site Status COMPLETED

Concord Hospital

Concord, , Australia

Site Status COMPLETED

Austin Health

Heidelberg, , Australia

Site Status COMPLETED

Peter MacCallum Cancer Institute

Melbourne, , Australia

Site Status COMPLETED

Royal Perth Hospital

Perth, , Australia

Site Status COMPLETED

Alfred Hospital

Prahran, , Australia

Site Status COMPLETED

Adventist Health Care Limited trading as San Clinical Trials Unit

Wahroonga, , Australia

Site Status RECRUITING

UZA

Antwerp, , Belgium

Site Status COMPLETED

A.Z. Sint Jan

Bruges, , Belgium

Site Status COMPLETED

UCL - Saint Luc

Brussels, , Belgium

Site Status RECRUITING

UZ Gent - departement oncologie

Ghent, , Belgium

Site Status COMPLETED

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

UCL Mont-Godinne

Yvoir, , Belgium

Site Status RECRUITING

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, , Brazil

Site Status COMPLETED

Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel

Salvador, , Brazil

Site Status COMPLETED

Instituto de Ensino e Pesquisa São Lucas

São Paulo, , Brazil

Site Status COMPLETED

Jewish General Hospital

Montreal, Quebec, Canada

Site Status COMPLETED

Peking University People's Hospital

Beijing, , China

Site Status RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Peking University First Hospital

Beijing, , China

Site Status COMPLETED

West China Hospital Sichuan University

Chengdu, , China

Site Status RECRUITING

Fujian Medical University

Fuzhou, , China

Site Status COMPLETED

Sun Yat-sen University Cancer Hospital

Guangzhou, , China

Site Status COMPLETED

Zhejiang University First Hospital

Hangzhou, , China

Site Status RECRUITING

Ruijin Hospital

Shanghai, , China

Site Status COMPLETED

Tangdu hospital the Fourth Military Medical

Shanxi, , China

Site Status RECRUITING

The First Affliated Hospital of Soochow University

Suzhou, , China

Site Status RECRUITING

The Institute of Hematological disease

Tianjin, , China

Site Status COMPLETED

Wuhan Union Hospital

Wuhan, , China

Site Status COMPLETED

Fundacion Santa Fe

Bogotá, , Colombia

Site Status COMPLETED

Fundacion Oftalmologica de Santander - FOSCAL

Floridablanca, , Colombia

Site Status COMPLETED

Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

Brno, , Czechia

Site Status COMPLETED

Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika

Prague, , Czechia

Site Status COMPLETED

Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

Prague, , Czechia

Site Status COMPLETED

Hopital Henri Mondor

Créteil, , France

Site Status RECRUITING

Hôpital E. Muller

Mulhouse, , France

Site Status COMPLETED

HOPITAL SAINT LOUIS - Hematology / Oncology

Paris, , France

Site Status COMPLETED

Hopital Necker Enfants Malades

Paris, , France

Site Status COMPLETED

Hopital Haut Leveque Service Maladie Du Sang

Pessac, , France

Site Status COMPLETED

CH LYON SUD - Hematology

Pierre-Bénite, , France

Site Status RECRUITING

CHU de Tours

Tours, , France

Site Status RECRUITING

Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany

Berlin, , Germany

Site Status COMPLETED

Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus

Dresden, , Germany

Site Status COMPLETED

Universitätsklinikum Essen; Klinik f. Hämatologie- Germany

Essen, , Germany

Site Status COMPLETED

Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie

Giessen, , Germany

Site Status RECRUITING

Universitätsklinikum Heidelberg Med. Klinik IV

Heidelberg, , Germany

Site Status COMPLETED

Universitätsklinikum des Saarlandes

Homburg/Saar, , Germany

Site Status COMPLETED

Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany

Magdeburg, , Germany

Site Status COMPLETED

OnkoNet Marburg GmbH

Marburg, , Germany

Site Status COMPLETED

Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany

Ulm, , Germany

Site Status COMPLETED

Laiko General Hospital - 1st department of Internal Medicine

Athens, , Greece

Site Status COMPLETED

G Papanikolaou Hospital of Thessaloniki

Thessalonikis, , Greece

Site Status COMPLETED

Semmelweis Egyetem, I. Belgyogyaszati Klinika

Budapest, , Hungary

Site Status COMPLETED

Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika

Szeged, , Hungary

Site Status COMPLETED

St James's Hospital

Dublin, , Ireland

Site Status COMPLETED

Haemek Medical Center

Afula, , Israel

Site Status COMPLETED

Hillel Yaffe Medical Center - Oncology

Hadera, , Israel

Site Status RECRUITING

Rambam Health Care Campus

Haifa, , Israel

Site Status COMPLETED

Rabin Medical Center Beilinson Campus

Petah Tikva, , Israel

Site Status COMPLETED

Sheba Medical Center

Ramat Gan, , Israel

Site Status COMPLETED

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status COMPLETED

DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''

Roma, , Italy

Site Status COMPLETED

A.O.Citta della Salute e della Scienza di Torino

Torino, , Italy

Site Status COMPLETED

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō City, , Japan

Site Status ACTIVE_NOT_RECRUITING

Hiroshima University Hospital

Hiroshima, , Japan

Site Status RECRUITING

Hokkaido University Hospital

Sapporo, , Japan

Site Status COMPLETED

Oaxaca Site Management Organization S.C.

Oaxaca City, , Mexico

Site Status COMPLETED

VU medisch centrum - Afd.Interne - INT

Amsterdam, , Netherlands

Site Status COMPLETED

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

Brzozów, , Poland

Site Status COMPLETED

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

Chorzów, , Poland

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status RECRUITING

Pratia MCM Krakow

Krakow, , Poland

Site Status RECRUITING

Oddzial Hematologii

Opole, , Poland

Site Status COMPLETED

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

Słupsk, , Poland

Site Status COMPLETED

Katedra I Klinika Hematologii Nowotworow Krwi I Transplantacji Szpiku

Wroclaw, , Poland

Site Status RECRUITING

Instituto Portugues de Oncologia

Lisbon, , Portugal

Site Status COMPLETED

Hospital De Santa Maria

Lisbon, , Portugal

Site Status COMPLETED

Instituto Portugues de Oncologia

Porto, , Portugal

Site Status ACTIVE_NOT_RECRUITING

Auxilio Mutuo Cancer Center

San Juan, , Puerto Rico

Site Status RECRUITING

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, , Russia

Site Status COMPLETED

Chelyabinsk Regiona Onc. Center

Chelyabinsk, , Russia

Site Status COMPLETED

Emergency Hospital of Dzerzhinsk

Dzerzhinsk, , Russia

Site Status RECRUITING

Cancer Research Center

Moscow, , Russia

Site Status COMPLETED

S.P. Botkin Moscow City Clinical Hospital

Moscow, , Russia

Site Status RECRUITING

Regional Clinical Hospital n.a.Semashko

Nizhny Novgorod, , Russia

Site Status RECRUITING

Medical Scientific Radiology - Center

Obninsk, , Russia

Site Status COMPLETED

Perm Medical Sanitary Unit#1

Perm, , Russia

Site Status COMPLETED

Republican Hospital named by V.A.Baranova

Petrozavodsk, , Russia

Site Status RECRUITING

Rostov Research Institute of Oncology

Rostov-on-Don, , Russia

Site Status COMPLETED

Ryazan Regional Clinical Hospital

Ryazan, , Russia

Site Status RECRUITING

Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, , Russia

Site Status RECRUITING

Federal Center of Heart, Blood and Endocrinology

Saint Petersburg, , Russia

Site Status RECRUITING

City Clinical Oncology Dispensary

Saint Petersburg, , Russia

Site Status COMPLETED

Leningrad region clinical hospital

Saint, , Russia

Site Status COMPLETED

Samara Region Clinical Hospital

Samara, , Russia

Site Status COMPLETED

Oncological dispensary #2

Sochi, , Russia

Site Status RECRUITING

Oncology Dispensary of Komi Republic

Syktyvkar, , Russia

Site Status COMPLETED

National Cancer Center

Goyang-si, , South Korea

Site Status COMPLETED

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, , South Korea

Site Status RECRUITING

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, , Spain

Site Status COMPLETED

Hosp. Univ. de La Princesa

Madrid, , Spain

Site Status COMPLETED

Hosp. Gral. Univ. Gregorio Maranon

Madrid, , Spain

Site Status COMPLETED

Hosp. Univ. Infanta Leonor

Madrid, , Spain

Site Status COMPLETED

Fundacion Jimenez Diaz

Madrid, , Spain

Site Status COMPLETED

Clinica Universitaria de Navarra

Pamplona, , Spain

Site Status COMPLETED

Hospital Clinico Universitario Salamanca

Salamanca, , Spain

Site Status RECRUITING

Sahlgrenska University hospital, Hematology Dept

Gothenburg, , Sweden

Site Status COMPLETED

Skanes universitetssjukhus

Lund, , Sweden

Site Status COMPLETED

Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

Stockholm, , Sweden

Site Status COMPLETED

Changhua Cristian Hospital

Changhua County, , Taiwan

Site Status COMPLETED

Ankara University

Ankara, , Turkey (Türkiye)

Site Status COMPLETED

American Hospital

Istanbul, , Turkey (Türkiye)

Site Status COMPLETED

Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status COMPLETED

Dokuz Eylul Universitesi Tip Fakultesi

Izmir, , Turkey (Türkiye)

Site Status COMPLETED

Erciyes University

Kayseri, , Turkey (Türkiye)

Site Status COMPLETED

Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

Cherkasy, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

Dnipro, , Ukraine

Site Status COMPLETED

SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine

Kharkiv, , Ukraine

Site Status COMPLETED

Khmelnitskiy Regional Hospital, Hematology Department

Khmelnitskiy, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine

Kiev, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine

Lviv, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

Vinnitsa, , Ukraine

Site Status COMPLETED

University Hospitals Birmingham NHS Trust,

Birmingham, , United Kingdom

Site Status RECRUITING

Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Site Status COMPLETED

Colchester Hospital University NHS

Colchester, , United Kingdom

Site Status RECRUITING

Beatson West Of Scotland Cancer Centre

Glasgow, , United Kingdom

Site Status COMPLETED

St James's Institute of Oncology

Leeds, , United Kingdom

Site Status COMPLETED

Leicester Royal Infirmary - Haematology

Leicester, , United Kingdom

Site Status COMPLETED

St Bartholomew's Hospital - Dept of Haematology

London, , United Kingdom

Site Status COMPLETED

University College London Hospitals NHSFT

London, , United Kingdom

Site Status COMPLETED

Kings College Hospital

London, , United Kingdom

Site Status COMPLETED

Christie Hospital

Manchester, , United Kingdom

Site Status COMPLETED

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status COMPLETED

Derriford Hospital

Plymouth, , United Kingdom

Site Status COMPLETED

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Site Status COMPLETED

Southampton General Hospital

Southampton, , United Kingdom

Site Status COMPLETED

Royal Marsden Hospital (Sutton)

Sutton, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Belgium Brazil Canada China Colombia Czechia France Germany Greece Hungary Ireland Israel Italy Japan Mexico Netherlands Poland Portugal Puerto Rico Russia South Korea Spain Sweden Taiwan Turkey (Türkiye) Ukraine United Kingdom

Central Contacts

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Study Contact

Role: CONTACT

Email: [email protected]

Other Identifiers

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2012-004225-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PCI-32765CAN3001

Identifier Type: OTHER

Identifier Source: secondary_id

CR100955

Identifier Type: -

Identifier Source: org_study_id