A Phase 1/2 Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma

NCT01796171 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: EudraCT: 2011-000033-36
• Study Type: interventional
• Target: 191
• Locations: 23 countries
• Sites: 94

Brief Summary

This study is a Phase 1/2 open-label three part study in patients with relapsed indolent Non-Hodgkin's lymohoma (NHL) (Parts A and C) or relapsed/refractory follicular lymphoma (FL) (Part B).

Conditions

Non-Hodgkin Lymphoma; Follicular Lymphoma

Keywords

Radioimmunotherapy; Lu-177; Phase I study; Phase II study; Betalutin

Outcome Measures

Primary Outcomes (3)

• Part A, Phase I

  Number of participants with dose limiting toxicities (DLTs) in Part A

  12 weeks

• Part A, Phase IIa

  Tumour response rates in patients in Part A receiving Betalutin based on evaluation of CT scan images including PET/CT imaging (and bone marrow biopsy if applicable).

  5 years

• Part B, Phase IIb

  Overall response rate in Part B defined as the number of participants with a best response of complete remission or partial remission at any time

  up to 5 years

Study Arms (13)

Part A, Arm 1: 10 MBq/kg Betalutin with lower dose lilotomab pre-dosing

EXPERIMENTAL

10 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing

Drug: 10 MBq/kg Betalutin; Drug: 40 mg lilotomab

Part A, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing

EXPERIMENTAL

15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing

Drug: 15 MBq/kg Betalutin; Drug: 40 mg lilotomab

Part A, Arm 1: 20 MBq/kg Betalutin with lower dose lilotomab pre-dosing

EXPERIMENTAL

20 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing

Drug: 20 MBq/kg Betalutin; Drug: 40 mg lilotomab

Part A, Arm 2: 10 MBq/kg Betalutin with no pre-dosing

EXPERIMENTAL

10 MBq/kg (based on body weight) Betalutin without pre-dosing

Drug: 10 MBq/kg Betalutin

Part A, Arm 2: 15 MBq/kg Betalutin with no pre-dosing

EXPERIMENTAL

15 MBq/kg (based on body weight) Betalutin without pre-dosing

Drug: 15 MBq/kg Betalutin

Part A, Arm 3: 15 MBq/kg Betalutin with rituximab pre-dosing

EXPERIMENTAL

15 MBq/kg (based on body weight) Betalutin with rituximab pre-dosing

Drug: 15 MBq/kg Betalutin; Drug: Rituximab

Part A, Arm 4: 15 MBq/kg Betalutin with higher dose lilotomab pre-dosing

EXPERIMENTAL

15 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing

Drug: 15 MBq/kg Betalutin; Drug: 100 mg/m2 lilotomab

Part A, Arm 4: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing

EXPERIMENTAL

20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing

Drug: 20 MBq/kg Betalutin; Drug: 100 mg/m2 lilotomab

Part A, Arm 5: 20 MBq/kg Betalutin with intermediate dose lilotomab pre-dosing

EXPERIMENTAL

20 MBq/kg (based on body weight) Betalutin with 60 mg/m2 (based on body surface area) lilotomab pre-dosing

Drug: 20 MBq/kg Betalutin; Drug: 60 mg/m2 lilotomab

Part B, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing

EXPERIMENTAL

15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing

Drug: 15 MBq/kg Betalutin; Drug: 40 mg lilotomab

Part B, Arm 2: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing

EXPERIMENTAL

20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing

Drug: 20 MBq/kg Betalutin; Drug: 100 mg/m2 lilotomab

Part B, Arm 3: 12.5 MBq/kg Betalutin with lower dose lilotomab pre-dosing

EXPERIMENTAL

12.5 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing

Drug: 40 mg lilotomab; Drug: 12.5 mBq/kg Betalutin

Part C: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing

EXPERIMENTAL

15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing

Drug: 15 MBq/kg Betalutin; Drug: 40 mg lilotomab

Interventions

10 MBq/kg Betalutin DRUG

Part A, Arm 1: 10 MBq/kg Betalutin with lower dose lilotomab pre-dosing; Part A, Arm 2: 10 MBq/kg Betalutin with no pre-dosing

15 MBq/kg Betalutin DRUG

Part A, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing; Part A, Arm 2: 15 MBq/kg Betalutin with no pre-dosing; Part A, Arm 3: 15 MBq/kg Betalutin with rituximab pre-dosing; Part A, Arm 4: 15 MBq/kg Betalutin with higher dose lilotomab pre-dosing; Part B, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing; Part C: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing

20 MBq/kg Betalutin DRUG

Part A, Arm 1: 20 MBq/kg Betalutin with lower dose lilotomab pre-dosing; Part A, Arm 4: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing; Part A, Arm 5: 20 MBq/kg Betalutin with intermediate dose lilotomab pre-dosing; Part B, Arm 2: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing

40 mg lilotomab DRUG

Part A, Arm 1: 10 MBq/kg Betalutin with lower dose lilotomab pre-dosing; Part A, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing; Part A, Arm 1: 20 MBq/kg Betalutin with lower dose lilotomab pre-dosing; Part B, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing; Part B, Arm 3: 12.5 MBq/kg Betalutin with lower dose lilotomab pre-dosing; Part C: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing

100 mg/m2 lilotomab DRUG

Part A, Arm 4: 15 MBq/kg Betalutin with higher dose lilotomab pre-dosing; Part A, Arm 4: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing; Part B, Arm 2: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing

60 mg/m2 lilotomab DRUG

Part A, Arm 5: 20 MBq/kg Betalutin with intermediate dose lilotomab pre-dosing

Rituximab DRUG

Part A, Arm 3: 15 MBq/kg Betalutin with rituximab pre-dosing

12.5 mBq/kg Betalutin DRUG

Part B, Arm 3: 12.5 MBq/kg Betalutin with lower dose lilotomab pre-dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed (by World Health Organization \[WHO\] classification) relapsed incurable non-Hodgkin B-cell lymphoma of following subtypes; follicular grade I-IIIA (for Part C, this excludes patients meeting Part B criteria, who should enter Part B), marginal zone, small lymphocytic, lymphoplasmacytic, mantle cell.
• Age ≥ 18 years.
• Part A: A pre-study WHO performance status of 0-1; Part C: WHO performance status of 0-2.
• Life expectancy should be ≥3 months.
• \<25% tumour cells in bone marrow biopsy (biopsy taken from a site not previously irradiated).
• Measurable disease by radiological methods.
• Women of childbearing potential must:
• understand that the study medication is expected to have teratogenic risk.
• have a negative pregnancy test.
• agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study medication, throughout study medication therapy and for 12 months after end of study medication therapy, even if she has amenorrhoea.
• Male patients must agree to use condoms during intercourse throughout study medication therapy and the following 12 months.
• Patients previously treated with native rituximab are eligible.
• The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow up visits and examination.
• The patient has been fully informed about the study and has signed the informed consent form.

You may not qualify if:

• Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, uncontrolled asthma/allergy requiring systemic steroids, known to be human immunodeficiency virus (HIV) positive.
• \. Laboratory values within 15 days pre-registration:
• Absolute neutrophil counts (ANC) ≤1.5×109/L.
• Part A: Platelet count ≤150×109/L; Part C: Platelet count \<150×109/L. For Part C, criteria 2a and 2b must be satisfied within 72 hours of the administration of rituximab
• Total bilirubin ≥30 mmol/L (Part A only). Total bilirubin \> 1.5×ULN (except patients with documented Gilbert's syndrome \[≥3.0 mg/dL\]) (Part C only).
• Alkaline phosphatase (ALP) and alanine transaminase (ALT) ≥4×normal level (Part A only).
• Aspartate transaminase (AST), ALT or ALP \>2.5×ULN (or \>5.0×ULN with liver involvement by primary disease). (Part C only).
• Creatinine ≥115 µmol/L (men), 97 µmol/L (women) (Part A only). Serum creatinine ≥1.5×ULN (Part C only).
• Haemoglobin \<9.0 g/dL (Part C only). 3. Known central nervous system (CNS) involvement of lymphoma. 4. Previous total body irradiation. 5. Positive test for human anti-murine antibody (HAMA) at screening. 6. Chemotherapy or immunotherapy received within the last 4 weeks prior to start of study treatment. Pre treatment with rituximab is allowed.
• \. Pregnant or lactating women. 8. Previous hematopoietic stem cell transplantation (autologous and allogenic). 9. Part A: Previous treatment with radioimmunotherapy. Part C: Not applicable. 10. Actively participating in another study or received an IMP within 4 weeks prior to enrolment.
• \. Receipt of live-attenuated vaccine within 30 days prior to enrolment. 12. Part A and Part C: Test positive for hepatitis B (HBsAg and anti-HBc). Part C only: Test positive for hepatitis C and human immunodeficiency virus (HIV).
• \. A known hypersensitivity to rituximab, lilotomab, Betalutin or murine proteins or any excipient used in rituximab, lilotomab, or Betalutin.
• Part B:
• Histologically confirmed (by WHO classification) relapsed non-Hodgkin B-cell FL (grade I IIIA).
• \. Male or female aged ≥18 years. 3. Received at least 2 prior systemic anti-neoplastic or immunotherapy-based regimens (maintenance therapy following a CR/PR is not considered to be a separate line of therapy). Systemic regimens including agents such as idelalisib or other PI3K inhibitors qualify as a prior line of therapy.

Sponsors & Collaborators

• Nordic Nanovector: lead
• ICON Clinical Research: collaborator

Study Sites (96)

University Of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

University of California, San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Baylor College of Medicine

Dallas, Texas, 75246, United States

Location

Royal Hobart Hospital

Hobart, 7000, Australia

Location

Medizinische Universitaet Innsbruck

Innsbruck, 6020, Austria

Location

Medizinische Universität Wien - AKH Wien, Universitaetsklinik fuer Innere Medizin I

Vienna, 1090, Austria

Location

Universitair Ziekenhuis Gent (UZ Gent)

Ghent, 9000, Belgium

Location

CH Jolimont

La Louvière, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

London Health Sciences Centre

London, N6A 5W9, Canada

Location

Sault Area Hospital

Sault Ste. Marie, P6B 0A8, Canada

Location

Princes Margaret Cancer Centre

Toronto, M5G 2M, Canada

Location

Clinical Hospital Centre Zagreb

Zagreb, 10 000, Croatia

Location

University Hospital Olomouc

Olomouc, 779 00, Czechia

Location

FNsP Ostrava

Ostrava-Poruba, 708 52, Czechia

Location

Aarhus Universitetshospital

Aarhus, DK-8000, Denmark

Location

Odense Univerisity Hospital

Odense, DK-5000, Denmark

Location

Helsinki University Hospital Comprehensive Cancer Center

Helsinki, Finland

Location

Central Hospital Of Central Finland

Jyväskylä, Finland

Location

Institut Bergonie

Bordeaux, France

Location

Chu Grenoble - Hopital Michallon

Grenoble, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

AP-HP La Pitié salpétrière

Paris, 75013, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau

Tours, France

Location

Orszagos Onkologiai Intezet, A-Belgyogyaszati Onkologiai Osztaly

Budapest, Hungary

Location

Semmelweis Egyetem, I Belgyogyaszati Klinika, Hematologiai Osztaly

Budapest, Hungary

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

St James's Hospital

Dublin, Ireland

Location

University Hospital Galway

Galway, Ireland

Location

Haemek Medical Center

Afula, Israel

Location

Asaf Harofeh Medical Center

Be’er Ya‘aqov, Israel

Location

Bnai Zion Medical Center (BZMC)

Haifa, Israel

Location

Rambam Health Care Campus (RHCC)

Haifa, Israel

Location

יHadassah Ein Karem Medical Center

Jerusalem, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

SS Antonio & Biagio and C. Arrigo Hospital

Alessandria, Italy

Location

"Istituto di Ematologia ed Oncologia Medica "" L. & A. Seragnoli""-Policlinico S. Orsola Malpighi"

Bologna, 40138, Italy

Location

Universita Degli Studi Di Firenze-Azienda Ospedaliero-Universitaria Careggi (AOUC)

Florence, 50134, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

Meldola, Italy

Location

Istituto Europeo di Oncologia (IEO)

Milan, Italy

Location

"Istituto Nazionale Tumori Fondazione G. Pascale"

Napoli, Italy

Location

Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, Italy

Location

AO Ordine Mauriziano di Torino

Torino, Italy

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Haukeland Universitetssjukehus

Bergen, Norway

Location

The Norwegian Radium Hospital

Oslo, 0310, Norway

Location

St Olav Hospital

Trondheim, 7006, Norway

Location

Szpital Morski Im.Pck W Gdynia

Gdynia, Poland

Location

Pratia MCM Kraków

Krakow, 50-510, Poland

Location

Centrum Onkologii

Warsaw, 02-097, Poland

Location

National University Hospital

Singapore, Singapore

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Corporacio Sanitaria Parc Taulí

Barcelona, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, Spain

Location

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, Spain

Location

Clinica Universidad De Navarra

Pamplona, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Health Research Institute La Fe - Hospital La Fe

Valencia, 46020, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46026, Spain

Location

Cancercentrum -Center of Oncology

Umeå, Sweden

Location

Kantonsspital Graubünden

Chur, Switzerland

Location

Cukurova Universitesi Tip Fakültesi, Ic Hastaliklari Anabilim Dali

Adana, Turkey (Türkiye)

Location

Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, Turkey (Türkiye)

Location

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi Ic

Ankara, Turkey (Türkiye)

Location

Hacettepe University Oncology Hospital

Ankara, Turkey (Türkiye)

Location

Eskisehir Osmangazi Universitesi Tip Fakultesi Ic Hastaliklar

Eskişehir, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi

Fatih, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakültesi

Izmir, Turkey (Türkiye)

Location

Celal Bayar Universitesi Tip Fakultesi

Manisa, Turkey (Türkiye)

Location

Ondokuz Mayis Universitesi

Samsun, Turkey (Türkiye)

Location

Gaziantep Universitesi Sahinbey Arastirma ve Uygulama

Şehitkamil, Turkey (Türkiye)

Location

Dorset Cancer Centre Poole Hospital

Poole, Dorset, BH15 2JB, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Western General Hospital

Edinburgh, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Imperial College Healthcare NHS Trust, Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

University College London Hospitals Nhs Foundation Trust

London, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Derriford Hospital

Plymouth, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Location

Related Publications (6)

• Dahle J, Repetto-Llamazares AH, Mollatt CS, Melhus KB, Bruland OS, Kolstad A, Larsen RH. Evaluating antigen targeting and anti-tumor activity of a new anti-CD37 radioimmunoconjugate against non-Hodgkin's lymphoma. Anticancer Res. 2013 Jan;33(1):85-95.

  PMID: 23267131 BACKGROUND

• Repetto-Llamazares AH, Larsen RH, Mollatt C, Lassmann M, Dahle J. Biodistribution and dosimetry of (177)Lu-tetulomab, a new radioimmunoconjugate for treatment of non-Hodgkin lymphoma. Curr Radiopharm. 2013 Mar;6(1):20-7. doi: 10.2174/1874471011306010004.

  PMID: 23256748 BACKGROUND

• Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

  PMID: 17242396 BACKGROUND

• Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.

  PMID: 25113753 BACKGROUND

• Londalen A, Blakkisrud J, Revheim ME, Madsbu UE, Dahle J, Kolstad A, Stokke C. FDG PET/CT parameters and correlations with tumor-absorbed doses in a phase 1 trial of 177Lu-lilotomab satetraxetan for treatment of relapsed non-Hodgkin lymphoma. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1902-1914. doi: 10.1007/s00259-020-05098-x. Epub 2020 Nov 16.

  PMID: 33196921 DERIVED

• Kolstad A, Illidge T, Bolstad N, Spetalen S, Madsbu U, Stokke C, Blakkisrud J, Londalen A, O'Rourke N, Beasley M, Jurczak W, Fagerli UM, Kascak M, Bayne M, Obr A, Dahle J, Rojkjaer L, Pascal V, Holte H. Phase 1/2a study of 177Lu-lilotomab satetraxetan in relapsed/refractory indolent non-Hodgkin lymphoma. Blood Adv. 2020 Sep 8;4(17):4091-4101. doi: 10.1182/bloodadvances.2020002583.

  PMID: 32877524 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Follicular

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: Nordic Nanovector

mail@nordicnanovector.com

+47 22 18 33 01

Study Officials

• Chris Freitag

  Nordic Nanovector

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 21, 2013
• Study Start: December 1, 2012
• Primary Completion: October 25, 2022
• Study Completion: October 27, 2022
• Last Updated: June 21, 2024
• Results First Posted: January 10, 2024

Record last verified: 2023-12

Locations

ES (9); NL (1); AU (1); BE (3); FI (2); CZ (2); IE (3); NO (3); HU (2); CA (3); SE (1); CR (1); CH (1); TU (10); IL (6); GB (9); IT (8); US (14); DK (2); FR (6); PL (3); SG (1); KR (3)