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

Amgen407 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

407

Conditions

Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenic Purpura

Interventions

RomiplostimBIOLOGICAL

Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adverse Events

One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once

Time frame: Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks.

Secondary Outcomes

Platelet Response (Definition 1)

Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of \>=50 x 10\^9/L

Time frame: Duration of treatment (up to 201 weeks)

Platelet Response (Definition 2)

Platelet response using definition 2 (a platelet count increase of \>=20 x 109/L from baseline)

Time frame: Duration of treatment (up to 201 weeks)

Data from ClinicalTrials.gov

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