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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01467661
First received: October 31, 2011
Last updated: June 22, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Essential Thrombocythemia (ET)
Drug: SPD422 (anagrelide hydrochloride)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-centre, Open-label, Extension Study to Investigate the Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Change From Baseline in Platelet Count at Final Assessment [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ] [ Designated as safety issue: No ]
    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 (<) 600 [ Time Frame: Baseline, 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) ] [ Designated as safety issue: No ]
    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 Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ] [ Designated as safety issue: No ]
    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 Who Achieved Shift From Baseline in Platelet Count [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ] [ Designated as safety issue: No ]
    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 was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) * 100.

  • Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ] [ Designated as safety issue: No ]
    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 Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    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 During Post-marketing Trial [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    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 Clinical Laboratory Result During Post-marketing Trial [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    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) Abnormalities [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 41
Study Start Date: November 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD422 (anagrelide hydrochloride) Drug: SPD422 (anagrelide hydrochloride)
Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary.
Other Names:
  • Xagrid
  • Agrylin

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have completed Study SPD422 308
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467661

Locations
Japan
Akita University Hospital
Akita-shi, Akita, Japan, 010-8543
Tokyo Metropolitan Cancer and Infectious diseases Center Kom
Honkomagome 3-18-22, Bunkyo-ku, Japan, 13 113-8677
Nippon Medical School Hospital
Sendagi 1-1-5, Bunkyo-ku, Japan, 13 113-8603
Chiba University Hospital
Chuo-ku Inohana 1-8-1, Chiba-shi, Japan, 12 260-8677
Tokai University Hospital
Shimokasuya143, Isehara-shi, Japan, 259-1143
Gunma University Hospital
Showa-machi 3-39-15, Maebashi-shi, Japan, 10 371-8511
NHO Tokyo Medical Center
Higashigaoka 2-5-1, Meguro-ku, Japan, 13 152-8902
University of Miyazaki Hospital
Miyazaki-shi, Miyazaki, Japan, 889-1692
Niigata Cancer Centre
Niigata-shi, Niigata, Japan, 951-8566
Okayama University Hospital
Kita-ku Shikata-cho 2-5-1, Okayama-shi, Japan, 33 700-8558
Osaka City University Hospital
Osaka-shi, Osaka, Japan, 545-0051
Osaka University Hospital
Suita-shi, Osaka, Japan, 565-0871
Hokkaido University Hospital
Kita-ku Kita14jo Nishi5, Sapporo-shi, Japan, 01 060-8648
Keio University Hospital
Shinjyuku-ku, Tokyo, Japan, 160-8582
Mie University Hospital
Edobashi 2-174, Tsu-shi, 24, Japan, 514-8507
Juntendo University Shizuoka Hospital
Nagaoka 1129, Izunokuni-shi, Japan, 22 410-2295
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Kanakura, Prof Osaka University Hospital
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01467661     History of Changes
Other Study ID Numbers: SPD422-309 
Study First Received: October 31, 2011
Results First Received: May 2, 2016
Last Updated: June 22, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Thrombocytosis
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders
Anagrelide
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016