Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim
A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim
2 other identifiers
interventional
75
9 countries
48
Brief Summary
The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2010
Typical duration for phase_2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 14, 2010
CompletedStudy Start
First participant enrolled
November 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2013
CompletedResults Posted
Study results publicly available
February 24, 2016
CompletedSeptember 21, 2022
September 1, 2022
2.8 years
June 10, 2010
January 27, 2016
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Months With Platelet Response During the 12-Month Treatment Period
The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10\^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.
12 months
Secondary Outcomes (4)
Percentage of Participants With ITP Remission
Up to 24 months
Percentage of Participants With Splenectomy During the 12-month Treatment Period
12 months
Number of Participants With Adverse Events
From first dose date of romiplostim to end of study (up to 24 months).
Number of Participants Who Developed Antibodies to Romiplostim
Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)
Study Arms (1)
Romiplostim
EXPERIMENTALParticipants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases continued in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.
Interventions
Romiplostim will be administered weekly by subcutaneous injection
Eligibility Criteria
You may qualify if:
- \- Subject has been diagnosed with primary ITP according to the American Society of Hematology (ASH) guidelines (George et al, 1996) and previously received only 1st line therapies.
- First line therapy is defined as corticosteroids, immunoglobulin G (IVIG), anti-D and vinca alkaloids (used for the treatment of ITP related thrombocytopenia only). A platelet transfusion at any time during the six month period since the original diagnosis would not exclude the subject from study participation
- Initial diagnosis of primary ITP within 6 months of enrollment
- Age ≥ 18 years at screening
- A single platelet count ≤ 30 x 10⁹/L at any time during the screening period
- Subject or subject's legally acceptable representative has provided informed consent
You may not qualify if:
- Known history of a bone marrow stem cell disorder
- Surgical resection of the spleen
- Subject has a history of cancer or current malignancy other than basal cell carcinoma or cervical cancer in-situ with active treatment or disease within 5 years of screening
- Known history of congenital thrombocytopenia
- Known history of hepatitis B, hepatitis C, or human immunodeficiency virus
- Positive H. pylori by urea breath test or stool antigen test at screening
- Known history of systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia
- Known history of antiphospholipid antibody syndrome or positive for lupus anticoagulant
- Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura
- Previous history of recurrent venous thromboembolism or thrombotic events or an occurrence within 5 years of enrollment.
- Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), eltrombopag, recombinant human thrombopoietin (rHuTPO) or any platelet producing agent
- Rituximab (for any indication) or mercaptopurine (6-MP) or anticipated use during the time of the proposed study
- All hematopoietic growth factors including interleukin-11 (IL-11) (oprelvekin) within 4 weeks before the screening visit
- Alkylating agents use at any time before or during the screening visit or anticipated during the time of the proposed study
- Known hypersensitivity to any recombinant E. coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (48)
Research Site
Anaheim, California, 92801, United States
Research Site
Orange, California, 92868, United States
Research Site
Boynton Beach, Florida, 33435, United States
Research Site
Bethesda, Maryland, 20817, United States
Research Site
Hickory, North Carolina, 28602, United States
Research Site
Philadelphia, Pennsylvania, 19140, United States
Research Site
Charleston, South Carolina, 29414, United States
Research Site
Richlands, Virginia, 24641, United States
Research Site
Randwick, New South Wales, 2031, Australia
Research Site
Woolloongabba, Queensland, 4102, Australia
Research Site
Adelaide, South Australia, 5000, Australia
Research Site
Brno, 625 00, Czechia
Research Site
Ostrava-Poruba, 708 52, Czechia
Research Site
Prague, 100 34, Czechia
Research Site
Prague, 128 08, Czechia
Research Site
Prague, 128 20, Czechia
Research Site
Bondy, 93143, France
Research Site
Créteil, 94010, France
Research Site
Dijon, 21000, France
Research Site
Pessac, 33604, France
Research Site
Toulouse, 31059, France
Research Site
Cologne, 50674, Germany
Research Site
Dresden, 01307, Germany
Research Site
Duisburg, 47166, Germany
Research Site
Düsseldorf, 40479, Germany
Research Site
Bari, 70124, Italy
Research Site
Catania, 95124, Italy
Research Site
Monza (MB), 20900, Italy
Research Site
Napoli, 80131, Italy
Research Site
Novara, 28100, Italy
Research Site
Roma, 00161, Italy
Research Site
San Giovanni Rotondo FG, 71013, Italy
Research Site
Vicenza, 36100, Italy
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Gdansk, 80-952, Poland
Research Site
Katowice, 40-032, Poland
Research Site
Lublin, 20-080, Poland
Research Site
Poznan, 61-505, Poland
Research Site
Wroclaw, 50-367, Poland
Research Site
Málaga, Andalusia, 29010, Spain
Research Site
Barcelona, Catalonia, 08035, Spain
Research Site
A Coruña, Galicia, 15006, Spain
Research Site
Alcorcón, Madrid, 28922, Spain
Research Site
Majadahonda, Madrid, 28222, Spain
Research Site
Coventry, CV2 2DX, United Kingdom
Research Site
Leeds, LS9 7TF, United Kingdom
Research Site
London, E1 2ES, United Kingdom
Research Site
London, SW17 0QT, United Kingdom
Research Site
Oxford, OX3 9DU, United Kingdom
Related Publications (4)
Newland A, Godeau B, Priego V, Viallard JF, Lopez Fernandez MF, Orejudos A, Eisen M. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016 Jan;172(2):262-73. doi: 10.1111/bjh.13827. Epub 2015 Nov 5.
PMID: 26537623BACKGROUNDCines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.
PMID: 28411254BACKGROUNDKuter DJ, Newland A, Chong BH, Rodeghiero F, Romero MT, Pabinger I, Chen Y, Wang K, Mehta B, Eisen M. Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies. Br J Haematol. 2019 May;185(3):503-513. doi: 10.1111/bjh.15803. Epub 2019 Feb 21.
PMID: 30793285BACKGROUNDKuter DJ, Arnold DM, Rodeghiero F, Janssens A, Selleslag D, Bird R, Newland A, Mayer J, Wang K, Olie R. Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials. Am J Hematol. 2020 Jun;95(6):643-651. doi: 10.1002/ajh.25776. Epub 2020 Mar 21.
PMID: 32129511BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 14, 2010
Study Start
November 30, 2010
Primary Completion
September 20, 2013
Study Completion
December 26, 2013
Last Updated
September 21, 2022
Results First Posted
February 24, 2016
Record last verified: 2022-09