An Observational Study to Evaluate the Efficacy of Biweekly Romiplostim in Adult Patients With ITP

• Status: Unknown status
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the efficacy of romiplostim administered at every other week in ITP patients who attained stable platelet counts ≥ 50 x 109/L for 4 consecutive weeks after weekly doses of romiplostim.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center

Criteria

Inclusion Criteria:

1. Subject has an ability to provide written informed consent prior to participating to the study

2. Subject is male or female ≥ 18 years of age

3. Subject has a diagnosis of immune thrombocytopenia (ITP) per the American Society of Hematology guidelines.

4. Subject received at least 1 prior therapy for ITP including corticosteroids, immunoglobulin, or splenectomy, but had an insufficient response to any of these treatment (PLT count should be < 30x109/L before romiplostim initiation.)

5. If subject had ever received TPO receptor agonist before, the patient can participate this study only after 8 weeks' wash out period

Exclusion Criteria:

1. Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder

2. Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product within 8 weeks

3. Subject has a known hypersensitivity to any recombinant E coli-derived product

4. Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening

5. Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator

6. Subject is pregnant or breast feeding