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New drug may keep chemo on track for lung, ovarian, and breast cancer patients

NCT ID NCT03937154

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether romiplostim can prevent chemotherapy delays or dose reductions caused by low platelet counts in people with lung, ovarian, or breast cancer. About 145 adults will receive either romiplostim or a placebo alongside their chemotherapy. The goal is to help patients complete their full chemo schedule on time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

145 people

The number who actually took part.

Started

Feb 2020

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject has provided informed consent prior to initiation of any study-specific activities/procedures or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent. * Males or females greater than or equal to 18 years of age at signing of the informed consent. * Documented active stage I, II, III or IV locally advanced or metastatic of the following tumor types: NSCLC, breast cancer, or ovarian cancer (includes fallopian tube epithelial carcinomas and peritoneal epithelial carcinoma of unknown primary), or any stage recurrent disease. Patients with documented locally advanced (stage III) NSCLC should not be amenable to definitive treatment with chemoradiation and/or surgery. * Subjects must be receiving cancer treatment with 21- or 28-day cycles, using one of the following carboplatinum-based combination chemotherapy regimens: carboplatin/gemcitabine based, carboplatin/pemetrexed based, carboplatin/liposomal doxorubicin based or carboplatin/taxane based (which includes either paclitaxel, nab-paclitaxel, or docetaxel) or single agent chemotherapy regimen with any of the above mentioned drugs. Use of combination regimens with one of the above carboplatinum-based regimens is permitted with (1) anti-angiogenic agents (such as bevacizumab); (2) targeted therapy (such as anti-epidermal growth factor agents or anti- human epidermal growth factor receptor 2) or (3) immune checkpoint inhibitors. Cycle duration is based on intervals between day 1 of chemotherapy cycles (overlapping with carboplatin intervals) every 21 or 28 day cycles for single agent regimens. OR, Subjects must have CIT from a non-protocol chemotherapy regimen, planning to start treatment with one of the above protocol chemotherapy regimens which has been delayed ≥ 1 week due to CIT. * Subjects must have a local platelet count ≤ 85 x 109/L on day 1 of the study. * Subjects must be at least 21 or 28 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if receiving a 21-day or 28-day cycle chemotherapy regimen, respectively. * Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Exclusion Criteria: * Acute lymphoblastic leukemia. * Acute myeloid leukemia. * Any myeloid malignancy. * Myelodysplastic syndrome. Baseline bone marrow biopsy is not required to rule out MDS. However, if a bone marrow biopsy and cytogenetics were performed as part of diagnostic or staging work-up, these results will be collected to confirm. * Myeloproliferative disease. * Multiple myeloma. * Within 4 months prior to enrollment, any history of active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of greater than 470 msec, pericardial disease, or myocardial infarction. * Major surgery less than or equal to 28 days or minor surgery less than or equal to 3 days prior to enrollment. * New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening. To be eligible, subjects must have received at least 14 days of anticoagulation for a new thrombotic event and considered to be stable and suitable for continued therapeutic anticoagulation during trial participation. * History of arterial thrombotic events (eg, myocardial ischemia, transient ischemic attack, or stroke) within 6 months prior to screening. * Evidence of active infection within 2 weeks prior to the first dose of study treatment. * Known human immunodeficiency virus infection with any detectable viral load at screening. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available use central laboratory results. * Known active of chronic hepatitis C or hepatitis B infection. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available use central laboratory results. Hepatitis B and C infection is based on the following results: * Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B). * Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B. * Positive hepatitis C virus antibody: hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C. * In addition to the conditions listed in exclusion criteria 201 through 206, secondary malignancy within the past 5 years except: * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. * Adequately treated cervical carcinoma in situ without evidence of disease. * Adequately treated breast ductal carcinoma in situ without evidence of disease. * Prostatic intraepithelial neoplasia without evidence of prostate cancer. * Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ. * Malignancy treated with curative intent and with no known active disease present for greater than or equal to 3 years before enrollment and felt to be at low risk for recurrence by the treating physician (excluding malignancies listed in exclusion criteria 201 - 206). * Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura). * Any combined modality regimen containing radiation therapy or surgery occurring concomitantly with neo-adjuvant chemotherapy or where radiation therapy is planned during the cycle preceding 3 planned on-study cycles of chemotherapy. Prior/Concomitant Therapy: \- Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor, eltrombopag, recombinant human TPO, any other TPO receptor agonist, or any investigational platelet producing agent. Prior/Concurrent Clinical Study Experience - Currently receiving (or plan to receive) treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. Diagnostic Assessments * Anemia (hemoglobin \< 80 g/L \[8 g/dL\]) on the day of initiation of investigational product as assessed by local labs. Use of red cell transfusions and erythropoietic stimulating agents is permitted throughout the study as per institutional guidelines. * Neutropenia (absolute neutrophil count less than 1 x 10 9/L) on the day of initiation of investigational product as assessed by local labs. Use of granulocyte-colony stimulating factor is permitted throughout the study as per institutional guidelines. * Abnormal renal function with creatinine clearance less than 30 mL/min using the Cockcroft-Gault estimated creatinine clearance as assessed by local laboratory. If local laboratory results are not available use central laboratory results. during screening. \- Abnormal liver function (total bilirubin greater than 3X ULN; alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] greater than 3X ULN for subjects without liver metastases or greater than or equal to 5X ULN for subjects with liver metastases) as assessed by local laboratory during screening. If local laboratory results are not available use central laboratory results. Other Exclusions * Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 7 months after treatment (and chemotherapy) discontinuation (females of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test.) * Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and for an additional 7 months after treatment (and chemotherapy) discontinuation. Refer to Appendix 5 for additional contraceptive information. * Males unwilling to use contraception\* (male condom or sexual abstinence) or their female partner(s) of childbearing potential who are unwilling to use a highly effective method of contraception during treatment (and chemotherapy) and for an additional 7 months after treatment (and chemotherapy) discontinuation. \*If the male's sole partner is of non-childbearing potential, he is not required to use additional forms of contraception during the study. * Subject has known sensitivity to any of the products to be administered during dosing. * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, COAs) to the best of the subject and investigator's knowledge. * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. * Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment (and chemotherapy) and for an additional 7 months after treatment (and chemotherapy) discontinuation. * Male subjects unwilling to abstain from donating sperm during treatment (and chemotherapy) and for an additional 7 months after treatment (and chemotherapy) discontinuation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Agios Loukas Clinic

    Thessaloniki, 55236, Greece

  • Agios Savvas Anticancer Hospital

    Athens, 11522, Greece

  • Alexandra Hospital

    Athens, 11528, Greece

  • American Oncology Partners, PA

    Bethesda, Maryland, 20817, United States

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800, Turkey (Türkiye)

  • Associação Hospitalar Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

  • Attikon University Hospital

    Athens, 12462, Greece

  • Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan

    Kazan', 420029, Russia

  • Basaksehir Cam ve Sakura Sehir Hastanesi

    Istanbul, 34480, Turkey (Türkiye)

  • Broome Oncology LLC

    Binghamton, New York, 13905, United States

  • Casa de Saude Santa Marcelina

    São Paulo, São Paulo, 08270-120, Brazil

  • Centro Medico Austral

    Buenos Aires, Distrito Federal, C1019ABS, Argentina

  • Centro Medico Imbanaco

    Cali, Valle del Cauca Department, 760042, Colombia

  • Centro Medico Nacional Siglo XXI

    México, 06720, Mexico

  • Centro de Atencion e Investigacion Cardiovascular del Potosi Sc

    San Luis Potosí City, San Luis Potosí, 78200, Mexico

  • Centro de Diagnostico Investigacion y Tratamiento

    Salta, 4400, Argentina

  • Centro de Investigaciones Clínicas Clínica Viedma

    Viedma, Río Negro Province, 8500, Argentina

  • Centro de Pesquisa da Serra Gaucha - Cepesg

    Caxias do Sul, Rio Grande do Sul, 95020-450, Brazil

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20-090, Poland

  • Centrum Onkologii im prof Franciszka Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85-796, Poland

  • Christus Highland Cancer Treatment Center

    Shreveport, Louisiana, 71105, United States

  • Christus Saint Frances Cabrini Hospital

    Alexandria, Louisiana, 71301, United States

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220, Brazil

  • Clinical hospital 2, Group of companies medsi

    Moscow, 125284, Russia

  • Colorado West Healthcare System dba Grand Valley Oncology

    Grand Junction, Colorado, 81505, United States

  • Communal Institution Chernivtsi Regional Clinical Oncological Dispensary

    Chernivtsi, 58013, Ukraine

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405, United States

  • Complex Oncology Center - Ruse EOOD

    Rousse, 7002, Bulgaria

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, Valencia, 12002, Spain

  • Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 06200, Turkey (Türkiye)

  • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

    Wroclaw, 53-413, Poland

  • Farkasgyepui Tudogyogyintezet

    Farkasgyepű, 8582, Hungary

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000, Hungary

  • Great Falls Clinic

    Great Falls, Montana, 59405, United States

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz

    Győr, 9024, Hungary

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi, 39401, United States

  • Henry Dunant Hospital Center

    Athens, 11526, Greece

  • Hospital Clinico Universitario San Cecilio

    Granada, Andalusia, 18016, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, Castille and León, 37007, Spain

  • Hospital Goyeneche

    Arequipa, 04001, Peru

  • Hospital Santa Maria Nai

    Ourense, Galicia, 32005, Spain

  • Hospital Universitario Madrid Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Nuestra Señora de Valme

    Seville, Andalusia, 41013, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013, Spain

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942, Spain

  • Hospital de Amor

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Iatriko Diavalkaniko Thessalonikis

    Thessaloniki, 57001, Greece

  • Inonu Universitesi Turgut Ozal Tip Merkezi

    Malatya, 44280, Turkey (Türkiye)

  • Instituto Oncologico Cordoba

    Córdoba, Córdoba Province, X5002HWE, Argentina

  • Instituto Oncologico IOB

    Barcelona, Catalonia, 08023, Spain

  • Instituto de Oncologia do Parana

    Curitba, Paraná, 81520-060, Brazil

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015, Romania

  • Institutul Oncologic, Prof Dr Alexandru Trestioreanu

    Bucharest, 022328, Romania

  • Institutul Oncologic, Prof Dr Alexandru Trestioreanu

    Bucharest, 022338, Romania

  • Institutul Regional de Oncologie Iasi

    Iași, 700483, Romania

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • Izmir Ekonomi Universitesi Medical Point Hastanesi

    Izmir, 35575, Turkey (Türkiye)

  • Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi

    Izmir, 35150, Turkey (Türkiye)

  • James Lind Centro de Investigacion del Cancer

    Temuco, Cautín, 4800827, Chile

  • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 5004, Hungary

  • Kocaeli Universitesi Tip Fakultesi Hastanesi

    Kocaeli, 41380, Turkey (Türkiye)

  • LLC Tonus

    Nizhny Novgorod, 603089, Russia

  • Liga Norte-Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59075-740, Brazil

  • Loema Instituto de Pesquisa Clinica e Consultores Ltda - Clinica Loema

    Campinas, São Paulo, 13010-001, Brazil

  • Los Angeles Cancer Network

    Anaheim, California, 92801, United States

  • Marmara Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34890, Turkey (Türkiye)

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical Oncology Associates PS

    Spokane, Washington, 99208, United States

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020, Austria

  • Medsi Group

    Moscow Region, 143442, Russia

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • Memorial Healthcare International SRL

    Bucharest, 013812, Romania

  • Mercy Medical Center

    Baltimore, Maryland, 21202, United States

  • Metaxa Anticancer Hospital

    Piraeus, 18537, Greece

  • Mid Florida Hematology and Oncology Centers PA

    Orange City, Florida, 32763, United States

  • Multiprofile Hospital for Active Treatment Serdika EOOD

    Sofia, 1632, Bulgaria

  • Namik Kemal Universitesi Hastanesi

    Tekirdağ, 59100, Turkey (Türkiye)

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi

    Konya, 42090, Turkey (Türkiye)

  • Oaxaca Site Management Organization SC

    Oaxaca City, 68000, Mexico

  • Ocala Oncology Center

    Ocala, Florida, 34474, United States

  • Omsk Regional Clinical Oncology Dispensary

    Omsk, 644013, Russia

  • Oncolab

    Craiova, 200385, Romania

  • Oncology Hematology Associates

    Springfield, Missouri, 65807, United States

  • Oncomedica Imat

    Montería, Departamento de Córdoba, 230002, Colombia

  • Oncosalud

    Lima, 15036, Peru

  • Oncotech

    La Paz, Baja California Sur, 23040, Mexico

  • Orchard Healthcare Research Inc

    Skokie, Illinois, 60076, United States

  • Orlandi Oncologia

    Santiago, 7500713, Chile

  • Pamukkale Universitesi Tip Fakultesi Hastanesi

    Denizli, 20070, Turkey (Türkiye)

  • Phylasis Clinical Research

    Cuautitlán Izcalli, 54769, Mexico

  • Phylasis Clinicas Research Toluca

    Toluca, 50090, Mexico

  • Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o

    Brzeziny, 95-060, Poland

  • Provita Centrum Medyczne Spzoo

    Tomaszów Mazowiecki, 97-200, Poland

  • Pérola Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamaria Ltda

    São Paulo, 01317-000, Brazil

  • Reformatus Pulmonologiai Centrum

    Törökbálint, 2045, Hungary

  • Regional Cancer Care Associates

    Sparta, New Jersey, 78071, United States

  • Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan

    Ufa, 450054, Russia

  • SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary

    Arkhangelsk, 163045, Russia

  • SC Medisprof SRL

    Cluj-Napoca, 400058, Romania

  • SC Oncomed SRL

    Timișoara, 300239, Romania

  • Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010, Turkey (Türkiye)

  • Saglik Bilimleri University Ankara Ataturk Chest Diseases and Chest Surgery Training and Research Ho

    Ankara, 06280, Turkey (Türkiye)

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706, United States

  • Saint Bernards Medical Center

    Jonesboro, Arkansas, 72401, United States

  • Saint Lukes University Health Network

    Bethlehem, Pennsylvania, 18015, United States

  • Sakarya Egitim ve Arastirma Hastanesi

    Sakarya, 54290, Turkey (Türkiye)

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Sotiria General Hospital

    Athens, 11527, Greece

  • Specialized Hospital for Active Treatment of Oncology EAD

    Sofia, 1756, Bulgaria

  • Specjalistyczny Szpital im Dra Alfreda Sokolowskiego

    Wałbrzych, 58-309, Poland

  • Spitalul Clinic Coltea

    Bucharest, 030171, Romania

  • Spitalul Municipal Ploiesti

    Ploieşti, 100337, Romania

  • Spitalul Universitar de Urgenta Elias

    Bucharest, 011461, Romania

  • State Healthcare Institution Goroda Moskvi City Clinical Hospital 1

    Moscow, 119049, Russia

  • State Institution of Public Health

    Ryazan, 390011, Russia

  • State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region

    Sochi, 354057, Russia

  • State Institution of Public Health Tambov Regional Oncology Dispensary

    Tambov, 390013, Russia

  • State budget institution of public health Pyatigorsk oncology dispensary

    Pyatigorsk, 357502, Russia

  • Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie

    Koszalin, 75-581, Poland

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104, United States

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

    Edirne, 22030, Turkey (Türkiye)

  • Transcarpathian Regional Clinical Oncological Dispensary

    Uzhhorod, 88011, Ukraine

  • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

    Matosinhos Municipality, 4464-513, Portugal

  • Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente

    Lisbon, 1769-001, Portugal

  • Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio

    Porto, 4099-001, Portugal

  • Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao

    Porto, 4200-319, Portugal

  • University Hospital of Heraklion

    Heraklion - Crete, 71500, Greece

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Miami School of Medicine

    Miami, Florida, 33136, United States

  • Uniwersytecki Szpital Kliniczny nr 2 Pum w Szczecinie

    Szczecin, 70-111, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569, Poland

  • Vencer e Oncoclinica

    Teresina, Piauí, 64049-200, Brazil

  • Vinnytsya Regional Clinical Oncological Dispensary

    Vinnytsia, 21029, Ukraine

  • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

    Przemyśl, 37-700, Poland

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902, United States

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