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Clinical Trial VICCNCPED10100

Title

An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)

Principal Investigator(s)

Richard Ho

Details

  • Protocol No. VICCNCPED10100
  • Open Date: 02/22/2010
  • Staging: Phase III
  • Age Group: Children
  • Scope: National
  • Objective: The primary objective of this study is to evaluate the safety of romiplostim as a long-term treatment in pediatric thrombocytopenic subjects with immune (idiopathic) thrombocytopenic purpura.
  • Disease Sites: Pediatrics; Benign Hematologic
  • Therapies: Therapy (NOS)
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT00508820
  • Secondary Protocol No: 20090340

Description

None Provided.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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 ≤ 30,000 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