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

NCT02334813 | Completed Phase 3 Results

• 1 other identifier: EIS2002
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Purpura, Thrombocytopenic, Idiopathic

Outcome Measures

Primary Outcomes (1)

• Remission Duration

  Percentage of patients in ongoing remission at 6 months

  6 months

Study Arms (2)

Arm A: daily prednisone

ACTIVE COMPARATOR

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.

Drug: Prednisone

Arm B: pulsed dexamethasone

ACTIVE COMPARATOR

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).

Drug: Dexamethasone

Interventions

Prednisone DRUG

Continuous daily therapy

Arm A: daily prednisone

Dexamethasone DRUG

4-day pulses every 3 weeks

Arm B: pulsed dexamethasone

Eligibility Criteria

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

You may qualify if:

• First episode of ITP

You may not qualify if:

• Pregnancy
• Glucocorticoid intolerance

Sponsors & Collaborators

• University Hospital, Essen: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Prednisone; Dexamethasone

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Steroids, Fluorinated

Results Point of Contact

• Title: Prof. Dr. Ulrich Dührsen
• Organization: University Hospital Essen, Germany

ulrich.duehrsen@uk-essen.de

+49 201 723

Study Officials

• Ulrich Dührsen, MD

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med.

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: July 1, 2002
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 9, 2017
• Results First Posted: June 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share