An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP

Amgen

Status and phase

Completed

Phase 3

Conditions

Thrombocytopenia

Thrombocytopenic Purpura

Idiopathic Thrombocytopenic Purpura

Treatments

Biological: Romiplostim

Study type

Interventional

Funder types

Industry

Identifiers

NCT00508820

20040209

Details and patient eligibility

About

This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are > 50,000.

Enrollment

407 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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