Phase 3
N=407
An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
Idiopathic Thrombocytopenic Purpura · Thrombocytopenia · Thrombocytopenic Purpura
Bottom Line
View on ClinicalTrials.gov: NCT00508820 ↗Enrolled (actual)
407
Serious AEs
30.0%
Results posted
Feb 2012
Primary outcome: Primary: Adverse Events — 162; 215 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Romiplostim (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
162; 215 | — |
| SECONDARY Platelet Response (Definition 1) |
156; 214 | — |
| SECONDARY Platelet Response (Definition 2) |
160; 220 | — |
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
Data sourced from ClinicalTrials.gov (NCT00508820). 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.