- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04837703
Managed Access Programs for ETB115, Eltrombopag
Study Overview
Detailed Description
Study Type
Expanded Access Type
- Intermediate-size Population
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
Managed Access provision is allowed per local laws/regulations.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Bone Marrow Failure Disorders
- Cytopenia
- Pathologic Processes
- Autoimmune Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Digestive System Diseases
- Hemorrhage
- Skin Manifestations
- Hematologic Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Communicable Diseases
- Blood Coagulation Disorders
- Flaviviridae Infections
- Bone Marrow Diseases
- Hemorrhagic Disorders
- Anemia
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura, Thrombocytopenic
- Purpura
- Hepatitis
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Hemic and Lymphatic Diseases
- Thrombocytopenia
- Purpura, Thrombocytopenic, Idiopathic
- Hepatitis C
- Anemia, Aplastic
- eltrombopag
Other Study ID Numbers
- CETB115B2003I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thrombocytopenia
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Fondazione IRCCS Policlinico San Matteo di PaviaActive, not recruitingThrombocytopenia, Isolated | Thrombocytopenia 4 | CYCS MUTATION- ASSOCIATED THROMBOCYTOPENIA THC4Italy
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Weill Medical College of Cornell UniversityColumbia University; New York Presbyterian HospitalCompletedAlloimmune Thrombocytopenia | Fetal Alloimmune ThrombocytopeniaUnited States
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Sylvia ElzekUnknownThrombocytopenia Neonatal
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Central Hospital, Nancy, FranceRecruitingHeparin-induced ThrombocytopeniaFrance
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Centre Hospitalier Universitaire de BesanconNot yet recruitingHeparin-induced Thrombocytopenia
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Veralox TherapeuticsCelerionCompletedHeparin-induced ThrombocytopeniaUnited States
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Aspen Global IncorporatedTerminatedHeparin-induced ThrombocytopeniaUnited States, Bosnia and Herzegovina, Canada, France, Germany, Italy, Poland, Russian Federation, Serbia
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Marshall UniversityUnknownHeparin-induced ThrombocytopeniaUnited States
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Napolitano MariasantaRegione SiciliaTerminatedThrombocytopenia | Primary Thrombocytopenia,Unspecified | Thrombocytopenia Chemotherapy InducedItaly
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Ottawa Hospital Research InstituteUnknownHeparin-induced Thrombocytopenia (HIT)Canada
Clinical Trials on Eltrombopag
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Novartis PharmaceuticalsCompleted
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Abhay Singh, MD MPHSuspendedMyelodysplastic Syndromes | Chronic Myelomonocytic LeukemiaUnited States
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Novartis PharmaceuticalsActive, not recruitingMyelodysplastic SyndromesJapan
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Novartis PharmaceuticalsCompletedPurpura, Thrombocytopenic, IdiopathicRussian Federation
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National Heart, Lung, and Blood Institute (NHLBI)CompletedModerate Aplastic Anemia | Unilineage Bone Marrow Failure DisordersUnited States
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Fondazione Progetto EmatologiaCompletedChronic Lymphocytic Leukemia | Purpura, Thrombocytopenic, Idiopathic | Non Hodgkin's Lymphoma | Autoimmune Thrombocytopenia | Autoimmune Thrombocytopenic PurpuraItaly
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Union Hospital, Tongji Medical College, Huazhong...Not yet recruitingPrimary Immune Thrombocytopenia (ITP)China
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Weill Medical College of Cornell UniversityNovartisTerminatedImmune ThrombocytopeniaUnited States
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Institute of Hematology & Blood Diseases Hospital...Xijing Hospital; Xi'an Central Hospital; The Second Hospital of Hebei Medical... and other collaboratorsCompletedPreviously Treated Primary Immune ThrombocytopeniaChina
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Tel-Aviv Sourasky Medical CenterNovartisRecruitingB Cell Lymphoma | CART TreatmentIsrael