Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01143038
• Date of registration: 10/06/2010
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim
• Scientific title: A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim
• Date of first enrolment: November 30, 2010
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01143038
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Czech Republic, Czechia, France, Germany, Italy, Poland, Spain, United Kingdom, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject has been diagnosed with primary ITP according to the American Society of
Hematology (ASH) guidelines (George et al, 1996) and previously received only 1st line
therapies.

First line therapy is defined as corticosteroids, immunoglobulin G (IVIG), anti-D and vinca
alkaloids (used for the treatment of ITP related thrombocytopenia only). A platelet
transfusion at any time during the six month period since the original diagnosis would not
exclude the subject from study participation

- Initial diagnosis of primary ITP within 6 months of enrollment

- Age = 18 years at screening

- A single platelet count = 30 x 10?/L at any time during the screening period

- Subject or subject's legally acceptable representative has provided informed consent

Exclusion Criteria:

- Known history of a bone marrow stem cell disorder

- Surgical resection of the spleen

- Subject has a history of cancer or current malignancy other than basal cell carcinoma
or cervical cancer in-situ with active treatment or disease within 5 years of
screening

- Known history of congenital thrombocytopenia

- Known history of hepatitis B, hepatitis C, or human immunodeficiency virus

- Positive H. pylori by urea breath test or stool antigen test at screening

- Known history of systemic lupus erythematosus, Evans syndrome, or autoimmune
neutropenia

- Known history of antiphospholipid antibody syndrome or positive for lupus
anticoagulant

- Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or
thrombotic thrombocytopenic purpura

- Previous history of recurrent venous thromboembolism or thrombotic events or an
occurrence within 5 years of enrollment.

- Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and
development factor (PEG-rHuMGDF), eltrombopag, recombinant human thrombopoietin
(rHuTPO) or any platelet producing agent

- Rituximab (for any indication) or mercaptopurine (6-MP) or anticipated use during the
time of the proposed study

- All hematopoietic growth factors including interleukin-11 (IL-11) (oprelvekin) within
4 weeks before the screening visit

- Alkylating agents use at any time before or during the screening visit or anticipated
during the time of the proposed study

- Known hypersensitivity to any recombinant E. coli-derived product (eg, Infergen,
Neupogen, Somatropin, and Actimmune)

- Currently enrolled in another investigational device or drug study, or less than 30
days since ending another investigational device or drug study(s), or receiving other
investigational agent(s)

- Subject will have any other investigational procedures performed while enrolled in
this clinical study

- Subject is pregnant or breast feeding, or planning to become pregnant within 5 weeks
after the end of treatment

- Female subject of child bearing potential is not willing to use, in combination with
her partner, highly effective contraception during treatment and for 4 weeks after the
end of treatment

- Subject has previously enrolled into a romiplostim study

- Subject will not be available for protocol required study visits, to the best of the
subject's and investigator's knowledge

- Subject has any kind of disorder that, in the opinion of the investigator, may
compromise the ability of the subject to give written informed consent and/or to
comply with all required study procedures



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Thrombocytopenic Purpura

Intervention(s)

Biological: Romiplostim

Primary Outcome(s)

Number of Months With Platelet Response During the 12-Month Treatment Period [Time Frame: 12 months]

Secondary Outcome(s)

Number of Participants Who Developed Antibodies to Romiplostim [Time Frame: Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)]

Number of Participants With Adverse Events [Time Frame: From first dose date of romiplostim to end of study (up to 24 months).]

Percentage of Participants With ITP Remission [Time Frame: Up to 24 months]

Percentage of Participants With Splenectomy During the 12-month Treatment Period [Time Frame: 12 months]

Secondary ID(s)

2010-019987-35

20080435

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/02/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01143038