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

Phase 1

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

Registration Number: EUCTR2007-000638-37-SK

Lead Sponsor: Amgen Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

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