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

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.

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Key information

Conditions

Idiopathic Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cardiovascular Diseases Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Jacobs syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombocytopenic Purpura Thrombotic Microangiopathies Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Romiplostim

Biological

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.

Primary outcomes

Adverse Events

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

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

Secondary outcomes

Platelet Response (Definition 1)

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

Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L
Platelet Response (Definition 2)

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

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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2011
Study completion: 2011
First posted: Jul 30, 2007
Registry last updated: Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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