The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.
The study includes a 4-week screening period, a 12-month romiplostim treatment period, and a romiplostim dose-tapering period. During the 12-month treatment period romiplostim doses could be increased or decreased to maintain a platelet count between ≥ 50 x 10\^9/L and ≤ 200 x 10\^9/L. Participants who dose reduce such that they no longer require treatment with romiplostim during the 12-month treatment period will continue with all required study procedures up to 12 months and will be monitored for ITP remission for at least 6 months. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L will enter the tapering period, during which the romiplostim dose will be decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. If a participant maintains a platelet count of ≥ 50 x 10\^9/L in the absence of romiplostim and all medications for ITP (concomitant or rescue), the participant will be followed for at least 6 months to confirm the incidence of ITP remission. If a participant's platelet count falls below 50 x 10\^9/L and the participant has tapered off treatment with romiplostim, the participant will enter the stabilization period and reinitiate romiplostim for up to 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Romiplostim will be administered weekly by subcutaneous injection
Number of Months With Platelet Response During the 12-Month Treatment Period
The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10\^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.
Time frame: 12 months
Percentage of Participants With ITP Remission
ITP remission was defined as maintaining every platelet count ≥ 50 x 10\^9/L for at least 6 months in the absence of romiplostim and any other therapies to treat ITP.
Time frame: Up to 24 months
Percentage of Participants With Splenectomy During the 12-month Treatment Period
If treatment with romiplostim was deemed ineffective or intolerable by the investigator, a splenectomy may have been performed.
Time frame: 12 months
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.
Time frame: From first dose date of romiplostim to end of study (up to 24 months).
Number of Participants Who Developed Antibodies to Romiplostim
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Research Site
Anaheim, California, United States
Research Site
Orange, California, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Bethesda, Maryland, United States
Research Site
Hickory, North Carolina, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Richlands, Virginia, United States
Research Site
Randwick, New South Wales, Australia
Research Site
Woolloongabba, Queensland, Australia
...and 38 more locations
The number of participants who developed antibody formation (defined as negative at baseline and positive at post-baseline, transient or persistent) to romiplostim, endogenous thrombopoietin (eTPO), and thrombopoietin mimetic peptide (TMP, the peptide component of romiplostim) was summarized.
Time frame: Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)