Phase 3 N=313 Randomized Treatment

Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Thrombocytopenia · Idiopathic Thrombocytopenic Purpura

Bottom Line

View on ClinicalTrials.gov: NCT00116688 ↗

Enrolled (actual)

313

Serious AEs

38.3%

Results posted

Apr 2011

Primary outcome: Primary: Number of Participants With Adverse Events — 284; 19 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Romiplostim (Biological)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	284; 19	—
SECONDARY Number of Participants With a Platelet Response	275; 20	—
SECONDARY Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies	30; 1	—
SECONDARY Change From Baseline in ITP Patient Assessment Questionnaire	4.20; 3.99; 6.43; 5.23; 4.01; 3.48	—
SECONDARY Change From Baseline in Short Form 36 (SF-36)	1.38; 2.03; 0.94; 1.31; 1.68; 0.52	—
SECONDARY Change From Baseline in Euroqol-5D (EQ-5D) Index Score	0.03	—
SECONDARY Change From Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS)	6.05	—
SECONDARY Patient Global Assessment	7.61; 8.18	—

Summary

The purpose of this study is to determine the safety of romiplostim as a long-term treatment in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to romiplostim, and to evaluate changes in patient reported outcomes due to the use of romiplostim. Participants must have previously completed a romiplostim ITP study.

Eligibility Criteria

Inclusion Criteria

Must have previously completed a romiplostim ITP study
Platelet count ≤ 50 x 10 ^9/L
Written informed consent

Exclusion Criteria

Bone marrow stem cell disorder or new active malignancies diagnosed since enrollment in the previous romiplostim ITP study
Received any alkylating agents within 4 weeks before screening visit or anticipated use during the time of the proposed study
Currently enrolled in or has not yet completed at least 4 weeks since ending device or drug trial(s) (other than the previous romiplostim ITP study), or subject is receiving other investigational agent(s) other than romiplostim
Not using adequate contraceptive precautions
Not available for follow-up assessments
Has any kind of disorder that compromises the ability of the participant to give informed consent and does not have a legally-acceptable representative and/or is unable to comply with study procedures.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00116688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.