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

NCT00508820 | Completed Phase 3 Results

• 1 other identifier: 20040209
• Study Type: interventional
• Target: 407
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Idiopathic Thrombocytopenic Purpura; Thrombocytopenia; Thrombocytopenic Purpura

Keywords

Platelet; AMG 531; Thrombopoietin; blood disorder; bleeding disorder; immune thrombocytopenic purpura; idiopathic thrombocytopenic purpura; immune (idiopathic) thrombocytopenic purpura; TPO; thrombopoietic protein

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (2)

• Platelet Response (Definition 1)

  Duration of treatment (up to 201 weeks)

• Platelet Response (Definition 2)

  Duration of treatment (up to 201 weeks)

Study Arms (1)

1

EXPERIMENTAL

Romiplostim

Biological: Romiplostim

Interventions

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Janssens A, Tarantino M, Bird RJ, Mazzucconi MG, Boccia RV, Fernandez MF, Kozak T, Steurer M, Boekhorst Pt, Dillingham K, Kreuzbauer G, Woodard P. Romiplostim Treatment in Adults with Immune Thrombocytopenia of Varying Duration and Severity. Acta Haematol. 2015;134(4):215-28. doi: 10.1159/000381657.

  PMID: 26066765 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia; Purpura, Thrombocytopenic; Jacobs syndrome; Hematologic Diseases; Hemostatic Disorders

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Purpura; Blood Coagulation Disorders; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: February 1, 2005
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 14, 2022
• Results First Posted: February 13, 2012

Record last verified: 2022-11