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An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00508820•Amgen

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Key Dates

Start Date

February 1, 2005

Primary Completion Date

January 1, 2011

Completion Date

March 1, 2011

Last Updated

November 14, 2022

Enrollment

407

ACTUAL participants

Conditions

Idiopathic Thrombocytopenic PurpuraThrombocytopeniaThrombocytopenic Purpura

Interventions

Romiplostim

BIOLOGICAL

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RECRUITINGPHASE3

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Thrombocytopenia, Neonatal Alloimmune

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)

Anti-CD38 Monoclonal Antibody Combined With Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)

A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)