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An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)

18 Years
Not Enrolling
Hematology, MDS, Myelodysplastic Syndromes, Thrombocytopenia

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Trial Information

An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)

Inclusion Criteria

Inclusion Criteria

- Subject completed a romiplostim study for the treatment of thrombocytopenia in
subjects with MDS

- Subject has an Eastern Cooperative Oncology (ECOG) performance status of 0 to 2

- Subject had a platelet count ≤ 50 x 10^9/L since the final dose of investigational
product in the parent study

- Subject or his/her legally acceptable representative provided written informed
consent before any study-specific procedures were initiated

Exclusion Criteria

- Subject has been diagnosed with AML or has a blast count ≥ 10% by peripheral blood or
bone marrow biopsy

- Subject has a prior history of leukemia

- Subject has a prior history of bone marrow or stem cell transplantation

- Subject has a prior malignancy (other than in situ cervical cancer, controlled
prostate cancer, or basal cell cancer of the skin) unless treated with curative
intent and without evidence of disease for ≥ 3 years before randomization

- Subject has active or uncontrolled infections

- Subject has unstable angina, congestive heart failure [New York Heart Association
(NYHA) > class II], uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled
cardiac arrhythmia, or recent (within 1 year) myocardial infarction

- Subject has a history of arterial thrombosis (eg, stroke or transient ischemic
attack) in the past year

- Subject has a history of venous thrombosis that currently requires anti-coagulation

- Subject received interleukin (IL)-11 within 4 weeks of screening

- Subject previously received a thrombopoietic growth factor (other than romiplostim)

- Subject has a known hypersensitivity to any recombinant E coli-derived product (eg,
Infergen®, Neupogen®, Somatropin, Actimmune)

- Subject is currently enrolled in investigational device or drug study(ies), has not
yet completed at least 4 weeks since ending investigational device or drug study(ies)
(other than parent romiplostim study), or subject is receiving other investigational

- Subject is of child-bearing potential and is evidently pregnant (eg, positive human
chorionic gonadotropin [HCG] test) or is breast feeding

- Subject is not using adequate contraceptive precautions

- Subject has any kind of disorder that compromises his/her ability to give written
informed consent (and does not have a legally acceptable representative) or is unable
to comply with study procedures

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To provide long-term safety data for the use of romiplostim in thrombocytopenic subjects with MDS

Outcome Time Frame:

Duration of the treatment

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:




Start Date:

April 2007

Completion Date:

December 2011

Related Keywords:

  • Hematology
  • MDS
  • Myelodysplastic Syndromes
  • Thrombocytopenia
  • Hematology
  • MDS
  • Myelodysplastic Syndromes
  • Thrombocytopenia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Thrombocytopenia