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Immunomodulation With Eltrombopag in ITP

NCT04812483 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-10-15

No results posted yet for this study

Summary

The study aims to investigate immunomodulatory effects of eltrombopag combined with dexamethasone in young and midlife adult patients with newly diagnosed primary Immune thrombocytopenia (ITP).

Conditions

  • Primary Immune Thrombocytopenia (ITP)

Interventions

DRUG

Eltrombopag (Revolade®)

Eltrombopag is a thrombopoietin receptor agonist (TPO-RA) indicated in patients with ITP refractory to first-line drugs or lasting more than 6 months. Administration of Eltrombopag (Revolade®), 50 mg PO, from day 5-140. Tapering over 1 week from day 141-148 with 50 mg every second day.

DRUG

standard therapy (without eltrombopag): HD-DXM

standard therapy (without eltrombopag): HD-DXM administered orally (40 mg) from day 1-4

Sponsors & Collaborators

  • Stiftung zur Förderung medizinischer und biologischer Forschung

    collaborator UNKNOWN

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • University of Erlangen-Nürnberg, Department of Biology

    collaborator UNKNOWN

  • University Children's Hospital Basel

    lead OTHER

Principal Investigators

  • Alexandra Schifferli, Dr. med. · University Children's Hospital Basel, UKBB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-04-11
Completion
2024-04-11

Countries

  • Switzerland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04812483 on ClinicalTrials.gov