- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02334813
Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia (EIS2002)
May 4, 2017 updated by: Ulrich Duehrsen, University Hospital, Essen
A Randomized Trial of Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- First episode of ITP
Exclusion Criteria:
- Pregnancy
- Glucocorticoid intolerance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Arm A: daily prednisone
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.
|
Continuous daily therapy
|
ACTIVE_COMPARATOR: Arm B: pulsed dexamethasone
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).
|
4-day pulses every 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remission Duration
Time Frame: 6 months
|
Percentage of patients in ongoing remission at 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ulrich Dührsen, MD, University Hospital, Essen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Primary Completion (ACTUAL)
January 1, 2015
Study Completion (ACTUAL)
January 1, 2015
Study Registration Dates
First Submitted
January 6, 2015
First Submitted That Met QC Criteria
January 7, 2015
First Posted (ESTIMATE)
January 8, 2015
Study Record Updates
Last Update Posted (ACTUAL)
June 9, 2017
Last Update Submitted That Met QC Criteria
May 4, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
- Prednisone
Other Study ID Numbers
- EIS2002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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