Immune Thrombocytopenia Management in Adults

Sponsor
Nahda University
Study ID
NCT05861297
Phase
PHASE4
Status
Unknown

Conditions

  • Immune Thrombocytopenia Purpura

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Patients were initiated with High Dose-Dexamethasone with a dose of 40 mg/m2 daily for four days per week immediately after the diagnosis of ITP for 6 months
  • Prednisolone and Azathioprine — DRUG
    the second group received 20 mg of Prednisolone three times daily and 1 mg/kg of oral Azathioprine once daily for two weeks, then tapering the Prednisolone dose through the subsequent weeks (6 weeks). While continuing treatment with Azathioprine for a total of six months.
  • Rituximab — DRUG
    The third group received 500 mg/m2 intravenously of Rituximab once weekly for one month
  • Eltrombopag — DRUG
    The fourth group received 50 mg of Eltrombopag four hours before or after meals as oral daily doses for 6 months
  • Romiplostim — DRUG
    The fifth group received 3μg/kg subcutaneous injection of Romiplostim once a week for 6 months

Study Details

Immune thrombocytopenia treatment has evolved recently. However, none of treatments have only benefits without drawbacks. This study compares the clinical outcomes and adverse drug patterns of different treatment options. Medications which will be assessed during the current study are High Dose-dexamethasone (HD-DXM) (control group), Prednisolone + Azathioprine, Rituximab, Eltrombopag, and Romiplostim.

Key Dates

Start date
May 5, 2020
Status verified
May 2023
Primary completion
Jan 18, 2024
Completion
Apr 2, 2024

Study Design

Enrollment
467 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    The first (control )group includes patients with confirmed diagnosed who received IV pulse (High Dose-Dexamethasone) therapy
  • Experimental: PSL - AZA group
    The second group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy
  • Experimental: The RTX group
    The third group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy
  • Experimental: The ELTRO group
    The fourth group includes patients with confirmed diagnosed who received E therapy
  • Experimental: The ROMP group
    The fifth group includes patients with confirmed diagnosed who received Romiplostim therapy

Primary Outcome Measure

total patients who achieved sustained and overall response [ Time Frame: 18 months ]

Central Contacts