Rituximab, Eltrombopag and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Study ID
NCT02834286
Phase
PHASE2
Status
Unknown

Conditions

  • Immune Thrombocytopenia

Eligibility Criteria

Sex
ALL
Age
16 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 100 mg weekly days 1, 7, 14, 21
  • Eltrombopag — DRUG
    Eltrombopag 50 mg PO days 1-28
  • Dexamethasone — DRUG
    Dexamethasone 40 mg IV/PO days 1-4

Study Details

The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab, eltrombopag and high-dose dexamethasone.

Key Dates

Start date
Mar 31, 2015
Status verified
Jul 2016
Primary completion
Mar 31, 2017
Completion
Sep 30, 2017

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab, eltrombopag and dexamethasone
    Each patient will receive Rituximab 100 mg weekly days 1, 7, 14, 21 Eltrombopag 50 mg PO days 1-28 Dexamethasone 40 mg IV/PO days 1-4

Primary Outcome Measure

Clinical Response [ Time Frame: 28 days ]

Central Contacts

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