Managed Access Programs for ETB115, Eltrombopag

NCT04837703 | Unknown

• 1 other identifier: CETB115B2003I
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this registration is to list Managed Access Programs (MAPs) related to ETB115, Eltrombopag

Conditions

Thrombocytopenia

Keywords

Eltrombopag; thrombocytopenia; Idiopathic thrombocytopenic purpura; ITP; Severe aplastic anemia; SAA; HCV; Hepatitis C virus

Interventions

Eltrombopag DRUG

Patients receive eltrombopag

Also known as: ETB115

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic; Anemia, Aplastic; Hepatitis C

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Thrombotic Microangiopathies; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Anemia; Bone Marrow Failure Disorders; Bone Marrow Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

MAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-access-programs

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 8, 2021
• Last Updated: April 15, 2026

Record last verified: 2026-04