Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia (EIS2002)

University Hospital Essen

Status and phase: Completed; Phase 3

Conditions: Purpura, Thrombocytopenic, Idiopathic

Treatments: Drug: Prednisone; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02334813

EIS2002

Details and patient eligibility

About

Patients above age 18 with a first episode of immune thrombocytopenia are randomized 1:1 between 2-4 weeks of daily prednisone (1 mg/kg/d) with subsequent dose tapering (arm A) and six 3-week cycles of pulsed dexamethasone (0.6 mg/kg/d, days 1-4; arm B). The primary endpoint is duration of remission defined as platelets ≥50/nl.

Full description

Patients above the age of 18 years with a first episode of immune thrombocytopenia (ITP) are eligible for inclusion, except pregnant women and patients unable to tolerate glucocorticoids. Diagnosis is made and treatment requirement defined according to the 1996 practice guidelines of the American Society of Hematology. The primary endpoint is duration of remission defined as platelets ≥50/nl. Secondary endpoints are response rate, complete remission (platelets ≥150/nl), cumulative cortisol equivalent dose (potency of prednisone / dexamethasone relative to cortisol: x 4 / x 30) and adverse events. During the first week of treatment all patients receive prednisone at 1 mg/kg/d. This period is used to confirm the diagnosis and identify patients with ITP secondary to lymphoproliferative, autoimmune (systemic lupus erythematosus, antiphospholipid syndrome) or infectious diseases (human immunodeficiency, hepatitis C, cytomegalovirus infection). Patients are stratified by age (cut-off: 50 years), gender and primary versus secondary ITP and then randomized 1:1 between daily prednisone (arm A) and pulsed dexamethasone (arm B). In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above. In arm B patients receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4). Patients failing to achieve or maintain a remission are switched to the alternative treatment arm (A: no response after 4 weeks of prednisone at 1-2 mg/kg/d, loss of response, maintenance doses exceeding the above limits; B: no response after 2 cycles, loss of response).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First episode of ITP

Exclusion criteria

• Pregnancy
• Glucocorticoid intolerance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Arm A: daily prednisone

Active Comparator group

Description:

During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to \<25 mg/d by week 14 and \<7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.

Treatment:

Drug: Prednisone

Arm B: pulsed dexamethasone

Active Comparator group

Description:

During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).

Treatment:

Drug: Dexamethasone