Idiopathic Thrombocytopenic PurpuraPhase 3NCT00451594
High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP
A Phase 3 study testing Dexamethasone and Prednisolone in people with Idiopathic Thrombocytopenic Purpura, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
Trial summary
To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- What is being tested?
- Dexamethasone and Prednisolone
- Type of treatment
- Pill or oral medicine
- How many people
- 157 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2005to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a true thrombocytopenia on blood smear
- adequate megakaryopoiesis on bone marrow examination
- the absence of clinically apparent associated conditions or cause of thrombocytopenia
- Age over 16 years
- A platelet count of less than 30x109/L
Who cannot join
- previous treatment for ITP.
- other causes of thrombocytopenia such as HIV infection, lymphproliferative disease, liver disease, or definite SLE.
- Patients with life threatening bleeding and pregnant women should be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura
To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP.
Read the detailed description
Patients will be randomized to one of two study arms:
dexamethasone 40 mg po daily for 4 consecutive days. If the platelet count drops below 30X109/L after response within 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering (Arm 1).
Prednisone 1 mg/kg po daily for 4-8 weeks, the drug is then decreased slowly over another few weeks (Arm 2).
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Being tested
- Dexamethasone, Prednisolone
- Keywords
- ITP
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexa
Pulse high dose dexamethasone (Arm 1)
- Patients will receive 40 mg of oral dexamethasone daily for four consecutive days.
- Other treatments should be considered if there was a platelet count of 30X109/L or less by day 14
- If the patient had a platelet count of more than 30X109/L after four days of dexamethasone treatment, no further treatment will be given.
- If the platelet count drops below 30X109/L within the first 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering.
- Patients whose platelet counts can not be maintained at 30X109/L will be offered other treatments.
PrednisoloneDrug
Also called PD
Conventional dose prednisone (Arm 2)
- Prednisone, 1 mg/kg is started at diagnosis. If the platelet count is more than 100X109/L, the dose should be used for 4 weeks minimally and then tapered by 10 mg/1 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/1 wk thereafter. (Ann Intern Med 1997, 126, 307-14). If the platelet count is between 30X109/L and 100X109/L, prednisone 1 mg/kg should be used for 8 weeks maximally and then tapered by 10 mg/2 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/2 wk thereafter.
- Guideline of prednisone tapering Duration of prednisone treatment: 3-6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate and platelet count
Endpoint definitions and criteria for evaluation: This study is designed to compare the effectiveness of high dose dexamethasone with conventional dose prednisone for patient with ITP. The effectiveness will be evaluated in terms of response rate and platelet count at 6 months after the treatment
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startSep 2005
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooperative Study Group A for Hematology
- Sponsor type
- Research network
- Investigators
- Sung Hwa Bae, professor, Principal investigator, Daegu Catholic Univertity Hospital, ROKJung-Hee Lee, professor, Principal investigator, Asan Medical Center, ROK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451594
- Sponsor's protocol ID
- C-009
- Status last verified
- Jan 2011
- First submitted
- 22 Mar 2007
- Last updated
- 13 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT00451594
- Acronym / sponsor ID
- C-009
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Keywords
- ITP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Cooperative Study Group A for HematologyResearch network
- Study start
- Sep 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP.
Detailed description
Patients will be randomized to one of two study arms:
dexamethasone 40 mg po daily for 4 consecutive days. If the platelet count drops below 30X109/L after response within 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering (Arm 1).
Prednisone 1 mg/kg po daily for 4-8 weeks, the drug is then decreased slowly over another few weeks (Arm 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- a true thrombocytopenia on blood smear
- adequate megakaryopoiesis on bone marrow examination
- the absence of clinically apparent associated conditions or cause of thrombocytopenia
- Age over 16 years
- A platelet count of less than 30x109/L
Key exclusion criteria (3 listed)
- previous treatment for ITP.
- other causes of thrombocytopenia such as HIV infection, lymphproliferative disease, liver disease, or definite SLE.
- Patients with life threatening bleeding and pregnant women should be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: DexaPulse high dose dexamethasone (Arm 1) 1. Patients will receive 40 mg of oral dexamethasone daily for four consecutive days. 2. Other treatments should be considered if there was a platelet count of 30X109/L or less by day 14 3. If the patient had a platelet count of more than 30X109/L after four days of dexamethasone treatment, no further treatment will be given. 4. If the platelet count drops below 30X109/L within the first 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering. 5. Patients whose platelet counts can not be maintained at 30X109/L will be offered other treatments. | Drug | – |
| PrednisoloneAlso: PDConventional dose prednisone (Arm 2) 1. Prednisone, 1 mg/kg is started at diagnosis. If the platelet count is more than 100X109/L, the dose should be used for 4 weeks minimally and then tapered by 10 mg/1 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/1 wk thereafter. (Ann Intern Med 1997, 126, 307-14). If the platelet count is between 30X109/L and 100X109/L, prednisone 1 mg/kg should be used for 8 weeks maximally and then tapered by 10 mg/2 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/2 wk thereafter. 2. Guideline of prednisone tapering Duration of prednisone treatment: 3-6 months | Drug | – |
Primary outcome
response rate and platelet count
Time frame: 6 years
Endpoint definitions and criteria for evaluation: This study is designed to compare the effectiveness of high dose dexamethasone with conventional dose prednisone for patient with ITP. The effectiveness will be evaluated in terms of response rate and platelet count at 6 months after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2011.
- A RANDOMIZED CONTROLLED MULTICENTER TRIAL OF HIGH DOSE DEXAMETHASONE VERSUS CONVENTIONAL DOSE PREDNISONE FOR ADULTS WITH UNTREATED IDIOPATHIC THROMBOCYTOPENIC PURPURALink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Hwa Bae, professor principal investigator
Daegu Catholic Univertity Hospital, ROK
Jung-Hee Lee, professor principal investigator
Asan Medical Center, ROK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and Prednisolone in people with Idiopathic Thrombocytopenic Purpura, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate and platelet count (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2011.