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

Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508820
• Other study ID #: 20040209
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2005
• Est. completion date: March 1, 2011

Study information

• Verified date: November 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: March 1, 2011
• Est. primary completion date: January 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytopenic Purpura

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Janssens A, Tarantino M, Bird RJ, Mazzucconi MG, Boccia RV, Fernández 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Platelet Response (Definition 1)	Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L	Duration of treatment (up to 201 weeks)
Secondary	Platelet Response (Definition 2)	Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)	Duration of treatment (up to 201 weeks)

External Links

•   AmgenTrials clinical trials website