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

NCT ID: NCT00508820

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-01
• Study Completion Date: 2011-03-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Romiplostim

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: 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.

Interventions

Romiplostim

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

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.

Reference Type: BACKGROUND

PMID: 26066765 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20040209

Identifier Type: -

Identifier Source: org_study_id