Idiopathic Thrombocytopenic PurpuraPhase 4PLATEFUNNCT00888901
Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag
A Phase 4 study testing eltrombopag and corticosteroids (Aprednislon) in people with Idiopathic Thrombocytopenic Purpura, run by Ingrid Pabinger, MD.
Trial summary
This is a single-center, prospective, controlled study with one eltrombopag treatment group and 2 control groups, one on standard steroid treatment, and another one untreated. The aim of the study is to determine the effect of Thrombopoietin Receptor (MPL) agonists on shear-induced platelet activation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- What is being tested?
- eltrombopag and corticosteroids (Aprednislon)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2009to May 2011
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with an established chronic autoimmune thrombocytopenia (cAITP)
- Age ≥ 18 and ≤ 90 years
- Females, if not pregnant, not nursing and consenting to perform safe anti-contraception
- Written consent before any study related procedure
- Platelet count < 50,000 /µL at screening
- At least one prior alternative cITP therapy
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- Inclusion Criteria (for patients treated with corticosteroids - Control group 1):
- Platelet count < 50,000 /µL in history
- At least 50% of the patients should have < 50,000 /µL at inclusion and should be followed for 3 months
- Inclusion Criteria (for patients untreated - Control group 2):
- Platelet count < 50,000 /µL in history
- At screening platelet count between 50,000 and 100,000 /µL
Who cannot join
- History of venous or arterial thromboembolism or stroke
- Known coronary heart disease or cardiac arrythmias
- Known HIV or Hepatitis C infection
- Impaired liver function defined as elevated ALT > 1.5 UNL, bilirubin more than ULN, albumin less than normal value
- Prothrombin time less than normal value
- Elevated creatinine level (> 1.3 ULN)
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- Unable/unwilling to follow protocol
- Previous or active malignancy
- Patients who have been included in any other study with eltrombopag any time before
- Patients treated with another investigational product within the last 3 months
About this study
Official title: Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.
This is a single-center, prospective, controlled study with one eltrombopag treatment group and 2 control groups, one on standard steroid treatment, and another one untreated.
The aim of the study is to determine the effect of Thrombopoietin Receptor (MPL) agonists on shear-induced platelet activation.
Read the detailed description
STUDY DESIGN:
Single-center (Medical University Vienna), prospective, controlled study. Patients will be recruited at the Division of Haematology and Haemostaseology at the Medical University in Vienna, one eltrombopag treatment group and 2 control groups, one on standard steroid treatment, another one untreated.
AIM OF THE STUDY:
To determine the effect of MPL agonists on shear-induced platelet activation. Data obtained from patients treated with eltrombopag shall be compared to those from untreated patients and patients on steroids. These investigations will extend previous studies that investigated platelet function without in vitro activation in patients receiving eltrombopag.
PATIENTS:
Trial Population:
Total number of patients n=34: 12 on eltrombopag, 12 on corticosteroids and 10 without treatment will be included in this trial.
Treatment with eltrombopag or corticosteroids. Eltrombopag starting dose: 25 mg/day, increased as needed (to 50 mg or maximum 75 mg once daily) every 2 weeks to reach a platelet count between 50,000-100000/µL and tapering the dosis if platelet count >= 100,000/µL. Afterwards, if platelet count stable (tolerance +/- 20%), platelet control every 4 weeks, otherwise weekly.
Prednisolone starting dose: 1 mg/kg/day to reach a platelet count between 50,000-100,000 /µL tapering of the dosage if platelet count >= 100,000/µL.
Laboratory Investigations:
In the eltrombopag group and in the newly treated prednisolone group platelet counts and platelet function tests will be performed at planned visits.
In patients who are on continuous corticosteroids (part of control group I) and untreated patients (control group II), which have a platelet count between 50,000 and 100,000/µL platelet counts, reticulated platelets, platelet function tests and platelet antibodies will be studied at entry and after 4 weeks (+ 5 days).
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Being tested
- eltrombopag, corticosteroids (Aprednislon)
- Keywords
- ITP, eltrombopag, platelet function, thrombocytopenia, Platelet function in patients with cAITP on eltrombopag
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eltrombopagDrug
Also called SB-497115-GR, Promacta (USA), Revolade (EU)
eltrombopag tablets daily, in increasing dosage, for three months
corticosteroids (Aprednislon)Drug
Also called Aprednislon
corticosteroids in decreasing dosage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients on eltrombopag Receives: Drug: eltrombopag |
| 2 | Active comparator | Patients on corticosteroids Receives: Drug: corticosteroids (Aprednislon) |
| 3 | No intervention | Untreated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The shear-induced platelet activation (SC) is considered as the primary outcome measure.
Measured: After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.
Secondary outcomes (1)
Rise of reticulated platelets and variation of platelet antibodies.
Measured: After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ingrid Pabinger, MD
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor-investigator, Ingrid Pabinger, MD, Medical University of Vienna
- Investigators
- Ingrid Pabinger, Prof. Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888901
- Sponsor's protocol ID
- IP-001
- Other IDs
- Eltrombopag 112650
- Acronym
- PLATEFUN
- Status last verified
- Apr 2012
- First submitted
- 27 Apr 2009
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Haselboeck J, Kaider A, Pabinger I, Panzer S. Function of eltrombopag-induced platelets compared to platelets from control patients with immune thrombocytopenia. Thromb Haemost. 2013 Apr;109(4):676-83. doi: 10.1160/TH12-07-0522. Epub 2013 Feb 7.
PubMed 23389750
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.
- ClinicalTrials.gov ID
- NCT00888901
- Acronym / sponsor ID
- PLATEFUN / IP-001
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Keywords
- ITP, eltrombopag, platelet function, thrombocytopenia, Platelet function in patients with cAITP on eltrombopag
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ingrid Pabinger, MDUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Apr 2009 (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.
This is a single-center, prospective, controlled study with one eltrombopag treatment group and 2 control groups, one on standard steroid treatment, and another one untreated.
The aim of the study is to determine the effect of Thrombopoietin Receptor (MPL) agonists on shear-induced platelet activation.
Detailed description
STUDY DESIGN:
Single-center (Medical University Vienna), prospective, controlled study. Patients will be recruited at the Division of Haematology and Haemostaseology at the Medical University in Vienna, one eltrombopag treatment group and 2 control groups, one on standard steroid treatment, another one untreated.
AIM OF THE STUDY:
To determine the effect of MPL agonists on shear-induced platelet activation. Data obtained from patients treated with eltrombopag shall be compared to those from untreated patients and patients on steroids. These investigations will extend previous studies that investigated platelet function without in vitro activation in patients receiving eltrombopag.
PATIENTS:
Trial Population:
Total number of patients n=34: 12 on eltrombopag, 12 on corticosteroids and 10 without treatment will be included in this trial.
Treatment with eltrombopag or corticosteroids. Eltrombopag starting dose: 25 mg/day, increased as needed (to 50 mg or maximum 75 mg once daily) every 2 weeks to reach a platelet count between 50,000-100000/µL and tapering the dosis if platelet count >= 100,000/µL. Afterwards, if platelet count stable (tolerance +/- 20%), platelet control every 4 weeks, otherwise weekly.
Prednisolone starting dose: 1 mg/kg/day to reach a platelet count between 50,000-100,000 /µL tapering of the dosage if platelet count >= 100,000/µL.
Laboratory Investigations:
In the eltrombopag group and in the newly treated prednisolone group platelet counts and platelet function tests will be performed at planned visits.
In patients who are on continuous corticosteroids (part of control group I) and untreated patients (control group II), which have a platelet count between 50,000 and 100,000/µL platelet counts, reticulated platelets, platelet function tests and platelet antibodies will be studied at entry and after 4 weeks (+ 5 days).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: eltrombopagPatients on eltrombopag |
| 2 | Active comparator | Drug: corticosteroids (Aprednislon)Patients on corticosteroids |
| 3 | No intervention | –Untreated patients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female patients with an established chronic autoimmune thrombocytopenia (cAITP)
- Age ≥ 18 and ≤ 90 years
- Females, if not pregnant, not nursing and consenting to perform safe anti-contraception
- Written consent before any study related procedure
- Platelet count < 50,000 /µL at screening
Key exclusion criteria (10 listed)
- History of venous or arterial thromboembolism or stroke
- Known coronary heart disease or cardiac arrythmias
- Known HIV or Hepatitis C infection
- Impaired liver function defined as elevated ALT > 1.5 UNL, bilirubin more than ULN, albumin less than normal value
- Prothrombin time less than normal value
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 |
|---|---|---|
| eltrombopagAlso: SB-497115-GR, Promacta (USA), Revolade (EU)eltrombopag tablets daily, in increasing dosage, for three months | Drug | 1 |
| corticosteroids (Aprednislon)Also: Aprednisloncorticosteroids in decreasing dosage | Drug | 2 |
Primary outcome
The shear-induced platelet activation (SC) is considered as the primary outcome measure.
Time frame: After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.
1 secondary outcome
Rise of reticulated platelets and variation of platelet antibodies.
Time frame: After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.
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 20 Apr 2012.
- Derived from this study: PubMed 23389750Haselboeck J, Kaider A, Pabinger I, Panzer S. Function of eltrombopag-induced platelets compared to platelets from control patients with immune thrombocytopenia. Thromb Haemost. 2013 Apr;109(4):676-83. doi: 10.1160/TH12-07-0522. Epub 2013 Feb 7.
- Division of hematology and hemostaseology, Med. Univ. ViennaLink 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.
Ingrid Pabinger, Prof. Dr. principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing eltrombopag and corticosteroids (Aprednislon) in people with Idiopathic Thrombocytopenic Purpura, run by Ingrid Pabinger, MD.
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 12 inclusion and 10 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 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The shear-induced platelet activation (SC) is considered as the primary outcome measure. (time frame: After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888901, which also lists 1 linked publication.
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 20 Apr 2012.