Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2022
• Main ID: NCT00415532
• Date of registration: 21/12/2006
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura
• Scientific title: A Randomized, Controlled, Open-label Study Evaluating the Efficacy and Tolerability of AMG 531 Versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
• Date of first enrolment: December 1, 2006
• Target sample size: 234
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00415532
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Poland, 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 Idiopathic Thrombocytopenia Purpura (ITP) according to the
American Society of Hematology (ASH) guidelines

- If subject is > 60 years of age, subject has a written bone marrow biopsy report
confirming the diagnosis of ITP

- Subject has received at least 1 prior therapy for ITP

- Subject has a platelet count < 50,000 or their platelet count falls to < 50,000 during
or after a clinically-indicated taper or discontinuation of current ITP therapy

- Before any study-specific procedure, the appropriate written informed consent must be
obtained

Exclusion Criteria:

- Subject has had a splenectomy for any reason

- Subject has an active malignancy

- Subject has a history of cancer, other than basal cell carcinoma or cervical carcinoma
in situ, with treatment or active disease within 5 years

- Subject has a known history of bone marrow stem cell disorder

- Subject has participated in any study evaluating polyethylene glycol-conjugated
recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF),
recombinant human thrombopoietin (rHuTPO), AMG 531, or a thrombopoietic protein

- Subject is receiving other investigational agents or procedures

- Subject is currently enrolled in, or has completed within the last 30 days, another
investigational device or drug study

- Subject is pregnant or breast feeding

- Subject is not using adequate contraceptive precautions

- Subject has known sensitivity to any recombinant E. coli-derived product

- Subject has any kind of disorder that compromises the ability of the subject to give
written informed consent and does not have a legally acceptable representative

- Subject has any kind of disorder that compromises the ability of the subject to comply
with study procedures



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

Health Condition(s) or Problem(s) studied

Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Thrombocytopenia

Idiopathic Thrombocytopenic Purpura

Thrombocytopenic Purpura

Intervention(s)

Drug: Medical Standard of Care for ITP

Biological: Romiplostim

Primary Outcome(s)

Number of Participants With Splenectomy During 52-Week Treatment Period [Time Frame: 52 weeks]

Number of Participants With Treatment Failure During 52-Week Treatment Period [Time Frame: 52 weeks]

Secondary Outcome(s)

Change in ITP-PAQ Physical Health Domain of Bother [Time Frame: Baseline and 52 weeks]

Change in ITP-PAQ Physical Health Domain of Activity [Time Frame: Baseline and 52 weeks]

Time to Splenectomy [Time Frame: 52 weeks]

Change in ITP-PAQ Physical Health Domain of Fatigue [Time Frame: Baseline and 52 weeks]

Change in ITP-PAQ Physical Health Domain of Symptoms [Time Frame: Baseline and 52 weeks]

Percentage of Participants With Platelet Response [Time Frame: Weeks 1-8, and Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

Secondary ID(s)

20060131

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/07/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00415532