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Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia

Phase 3
Completed
Conditions
Essential Thrombocythemia (ET)
Interventions
Drug: SPD422 (anagrelide hydrochloride)
Registration Number
NCT01467661
Lead Sponsor
Shire
Brief Summary

The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
Inclusion Criteria
  • Subjects must have completed Study SPD422 308
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
SPD422 (anagrelide hydrochloride)SPD422 (anagrelide hydrochloride)-
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Who Achieved Shift From Baseline in Platelet CountBaseline and final assessment (within 5 days of the last dose of investigational product)

Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last nonmissing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who had platelet count \<600 x 10\^9 platelet per liter and greater than equal (\>=) 600 x 10\^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) \* 100.

Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing TrialBaseline and final assessment (within 5 days of the last dose of investigational product)

Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who achieved platelet count \<600 x 10\^9 platelets per liter during the post-marketing trial were reported.

Percentage of Participants With TEAEs and TESAEs Related to Vital SignsFrom start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.

Change From Baseline in Platelet Count at Final AssessmentBaseline and final assessment (within 5 days of the last dose of investigational product)

Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit).

Percentage of Participants Who Achieved Platelet Count Less Than (<) 600Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product)

Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who achieved platelet count \<600 x 10\^9 platelets per liter at each visit were reported.

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.

Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory ResultFrom start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.

Change From Baseline in Platelet Count During Post-marketing Trial at Final AssessmentBaseline and final assessment (within 5 days of the last dose of investigational product)

Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit).

Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing TrialBaseline and final assessment (within 5 days of the last dose of investigational product)

Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who had platelet count \<600 x 10\^9 platelet per liter and greater than equal (\>=) 600 x 10\^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) \* 100.

Percentage of Participants With TEAEs and TESAEs During Post-marketing TrialFrom start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.

Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing TrialFrom start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.

Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing TrialFrom start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.

Number of Participants With Clinically Significant Electrocardiogram (ECG) AbnormalitiesFrom start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (16)

Osaka City University Hospital

🇯🇵

Osaka-shi, Osaka, Japan

University of Miyazaki Hospital

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Miyazaki-shi, Miyazaki, Japan

Keio University Hospital

🇯🇵

Tokyo, Japan

Gunma University Hospital

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Showa-machi 3-39-15, Maebashi-shi, Japan

Akita University Hospital

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Akita-shi, Akita, Japan

Tokyo Metropolitan Cancer and Infectious diseases Center Kom

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Honkomagome 3-18-22, Bunkyo-ku, Japan

Nippon Medical School Hospital

🇯🇵

Sendagi 1-1-5, Bunkyo-ku, Japan

Chiba University Hospital

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Chuo-ku Inohana 1-8-1, Chiba-shi, Japan

Hokkaido University Hospital

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Sapporo-shi, Hokkaidō Prefecture, Japan

Tokai University Hospital

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Isehara-shi, Kanagawa Prefecture, Japan

NHO Tokyo Medical Center

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Higashigaoka 2-5-1, Meguro-ku, Japan

Mie University Hospital

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Tsu-shi, Mie, Japan

Niigata Cancer Centre

🇯🇵

Niigata-shi, Niigata, Japan

Okayama University Hospital

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Okayama-shi, Okayama Prefecture, Japan

Osaka University Hospital

🇯🇵

Suita-shi, Osaka, Japan

Juntendo University Shizuoka Hospital

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Izunokuni-shi, Shizuoka Prefecture, Japan

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