Clinical trial NCT00508820: An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
Official title: An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Thrombocytopenic Purpura
Thrombocytopenia
Thrombocytopenic Purpura
Keywords: Platelet
AMG 531
Thrombopoietin
blood disorder
bleeding disorder
immune thrombocytopenic purpura
idiopathic thrombocytopenic purpura
immune (idiopathic) thrombocytopenic purpura
TPO
thrombopoietic protein
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-07-30
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are \> 50,000.


Eligibility criteria: Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines
* If Subject is \> 60 years of age, subject has a written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP
* Subject has received at least 1 prior therapy for ITP
* Subject's platelet count is ≤ 30,000 or the subject is experiencing bleeding that is uncontrolled with conventional therapies
* Subject (or legally-acceptable representative) is willing and able to provide written informed consent

Exclusion Criteria:

* Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
* Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product
* Subject has a known hypersensitivity to any recombinant E coli-derived product
* 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
* Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
* Subject is pregnant or breast feeding
* Investigator has concerns regarding the subject's ability to comply with the protocol procedures

Primary outcomes:
measure: Adverse Events
timeFrame: Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks.
Secondary outcomes:
measure: Platelet Response (Definition 1)
timeFrame: Duration of treatment (up to 201 weeks)
measure: Platelet Response (Definition 2)
timeFrame: Duration of treatment (up to 201 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Janssens A, Tarantino M, Bird RJ, Mazzucconi MG, Boccia RV, Fernandez MF, Kozak T, Steurer M, Boekhorst Pt, Dillingham K, Kreuzbauer G, Woodard P. Romiplostim Treatment in Adults with Immune Thrombocytopenia of Varying Duration and Severity. Acta Haematol. 2015;134(4):215-28. doi: 10.1159/000381657.