Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim

Completed · Phase 2

Conditions studied: Idiopathic Thrombocytopenic Purpura

In brief

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.

Key facts

Study ID: NCT01143038
Run by: Amgen
People needed: 75
Starts: 2010-11-30
Expected to finish: 2013-12-26
Last updated by the study team: 2022-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
Subject will have any other investigational procedures performed while enrolled in this clinical study
Subject is pregnant or breast feeding, or planning to become pregnant within 5 weeks after the end of treatment
Female subject of child bearing potential is not willing to use, in combination with her partner, highly effective contraception during treatment and for 4 weeks after the end of treatment
Subject has previously enrolled into a romiplostim study
Subject will not be available for protocol required study visits, to the best of the subject's and investigator's knowledge
Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures

Where it is running

Research Site — Anaheim, California, United States
Research Site — Orange, California, United States
Research Site — Boynton Beach, Florida, United States
Research Site — Bethesda, Maryland, United States
Research Site — Hickory, North Carolina, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Charleston, South Carolina, United States
Research Site — Richlands, Virginia, United States
Research Site — Randwick, New South Wales, Australia
Research Site — Woolloongabba, Queensland, Australia
Research Site — Adelaide, South Australia, Australia
Research Site — Brno, Czechia
Research Site — Ostrava-Poruba, Czechia
Research Site — Prague, Czechia
Research Site — Prague, Czechia
Research Site — Prague, Czechia
Research Site — Bondy, France
Research Site — Créteil, France
Research Site — Dijon, France
Research Site — Pessac, France
Research Site — Toulouse, France
Research Site — Cologne, Germany
Research Site — Dresden, Germany
Research Site — Duisburg, Germany
Research Site — Düsseldorf, Germany

Full record on ClinicalTrials.gov

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