An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-000638-37-GB
• Date of registration: 11/04/2008
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
• Scientific title: An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
• Date of first enrolment: 18/08/2008
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000638-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria, Belgium, Czech Republic, Ireland, Italy, Netherlands, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion 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 x10^9/L 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Exclusion Criteria
• Subject has a history of hematological malignancy, myeloproliferative disorder, 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Immune (Idiopathic) Thrombocytopenic Purpura
MedDRA version: 9.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura

Intervention(s)

Product Name: Romiplostim
Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Romiplostim
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 600-

Primary Outcome(s)

Primary end point(s): The primary endpoint is the incidence of adverse events, including clinically significant
changes in laboratory values and incidence of antibody formation.

Main Objective: The primary objective of this study is to evaluate the safety of romiplostim in adult thrombocytopenic subjects with ITP.

Secondary Objective: This study will also evaluate hematological responses to Romiplostim.

Secondary ID(s)

2007-000638-37-NL

20040209