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Study Complete
Sponsor ID
20060131

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

Sponsor ID
20060131
Clinicaltrials.gov ID
NCT00415532
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible after the initiation of romiplostim. After the completion or discontinuation of the study treatment period, any participant who does not transfer in to another romiplostim study will complete a 6-month Safety Follow-up period.

Additional Study Details

Phase
Phase 3
Product
romiplostim
Type
Interventional
Masking
None (Open Label)
Enrollment
234
Additional Study Details

Protocol Summary

Primary Outcome Measures

Splenectomy During 52-Week Treatment Period

Timeframe: 52 weeks

Treatment Failure During 52-Week Treatment Period

Timeframe: 52 weeks

Secondary Outcome Measures

Time to splenectomy

Timeframe: 52 weeks

Platelet Response

Timeframe: Up to 52 weeks

Change in ITP-PAQ Physical Health Domain of Symptoms

Timeframe: Baseline and 52 weeks

Change in ITP-PAQ Physical Health Domain of Bother

Timeframe: Baseline and 52 weeks

Change in ITP-PAQ Physical Health Domain of Activity

Timeframe: Baseline and 52 weeks

Change in ITP-PAQ Physical Health Domain of Fatigue

Timeframe: Baseline and 52 weeks

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Thrombocytopenia
    • Sex
    All
    Trial Dates
    Dec 2006 - Nov 2008
    Inclusion and 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