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

Phase 3

Completed

• Conditions: Thrombocytopenic Purpura; Idiopathic Thrombocytopenic Purpura; Thrombocytopenia
• Interventions: Biological: Romiplostim

• Registration Number: NCT00508820
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-01
• Study First Submitted: 2007-07-26
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-30
• Primary Completion: 2011-01-01
• Study Completion: 2011-03-01
• Results First Submitted: 2012-01-11
• Results First Submitted QC: 2012-01-11
• Results First Posted: 2012-02-13
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Romiplostim	Romiplostim

Primary Outcome Measures

Name	Time	Method
Adverse Events	Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks.	One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once

Secondary Outcome Measures

Name	Time	Method
Platelet Response (Definition 2)	Duration of treatment (up to 201 weeks)	Platelet response using definition 2 (a platelet count increase of \>=20 x 109/L from baseline)
Platelet Response (Definition 1)	Duration of treatment (up to 201 weeks)	Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of \>=50 x 10\^9/L