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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00888901
Other study ID # IP-001
Secondary ID Eltrombopag 1126
Status Completed
Phase Phase 4
First received April 27, 2009
Last updated April 19, 2012
Start date May 2009
Est. completion date May 2011

Study information

Verified date April 2012
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria (for all groups):

- 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

Inclusion Criteria (for patients treated with eltrombopag):

- Platelet count < 50,000 /µL at screening

- At least one prior alternative cITP therapy

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

Exclusion Criteria (for all patients):

- 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)

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
eltrombopag
eltrombopag tablets daily, in increasing dosage, for three months
corticosteroids (Aprednislon)
corticosteroids in decreasing dosage

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ingrid Pabinger, MD GlaxoSmithKline

Outcome

Type Measure Description Time frame Safety issue
Primary The shear-induced platelet activation (SC) is considered as the primary outcome measure. After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.
Secondary Rise of reticulated platelets and variation of platelet antibodies. After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.
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