An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP

• Register: ClinicalTrials.gov
• Last refreshed on: 21 November 2022
• Main ID: NCT00508820
• Date of registration: 26/07/2007
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
• Scientific title: An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
• Date of first enrolment: February 1, 2005
• Target sample size: 407
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00508820
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Ireland, Italy, Netherlands, Poland, Slovakia, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Thrombocytopenia

Idiopathic Thrombocytopenic Purpura

Thrombocytopenic Purpura

Intervention(s)

Biological: Romiplostim

Primary Outcome(s)

Adverse Events [Time Frame: Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks.]

Secondary Outcome(s)

Platelet Response (Definition 1) [Time Frame: Duration of treatment (up to 201 weeks)]

Platelet Response (Definition 2) [Time Frame: Duration of treatment (up to 201 weeks)]

Secondary ID(s)

20040209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/02/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00508820