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

NCT01467661 | Completed Phase 3 Results

• 1 other identifier: SPD422-309
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 16

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.

Conditions

Essential Thrombocythemia (ET)

Outcome Measures

Primary Outcomes (13)

• Change From Baseline in Platelet Count at Final Assessment

  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).

  Baseline and final assessment (within 5 days of the last dose of investigational product)

• Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment

  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).

  Baseline and final assessment (within 5 days of the last dose of investigational product)

• Percentage of Participants Who Achieved Platelet Count Less Than (<) 600

  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.

  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)

• Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial

  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.

  Baseline and final assessment (within 5 days of the last dose of investigational product)

• Percentage of Participants Who Achieved Shift From Baseline in Platelet Count

  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.

  Baseline and final assessment (within 5 days of the last dose of investigational product)

• Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial

  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.

  Baseline and final assessment (within 5 days of the last dose of investigational product)

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

  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.

  From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

• Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial

  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.

  From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

• Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result

  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.

  From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

• Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial

  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.

  From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

• Percentage of Participants With TEAEs and TESAEs Related to Vital Signs

  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.

  From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

• Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial

  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.

  From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

• Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

  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.

  From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product

Study Arms (1)

SPD422 (anagrelide hydrochloride)

EXPERIMENTAL

Drug: SPD422 (anagrelide hydrochloride)

Interventions

SPD422 (anagrelide hydrochloride) DRUG

Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary.

Also known as: Xagrid, Agrylin

SPD422 (anagrelide hydrochloride)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have completed Study SPD422 308

Sponsors & Collaborators

• Shire: lead

Study Sites (16)

Akita University Hospital

Akita, Akita, 010-8543, Japan

Location

Tokyo Metropolitan Cancer and Infectious diseases Center Kom

Honkomagome 3-18-22, Bunkyo-ku, 13 113-8677, Japan

Location

Nippon Medical School Hospital

Sendagi 1-1-5, Bunkyo-ku, 13 113-8603, Japan

Location

Chiba University Hospital

Chuo-ku Inohana 1-8-1, Chiba-shi, 12 260-8677, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaidō Prefecture, 01 060-8648, Japan

Location

Tokai University Hospital

Isehara-shi, Kanagawa, 259-1143, Japan

Location

Gunma University Hospital

Showa-machi 3-39-15, Maebashi-shi, 10 371-8511, Japan

Location

NHO Tokyo Medical Center

Higashigaoka 2-5-1, Meguro-ku, 13 152-8902, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

University of Miyazaki Hospital

Miyazaki, Miyazaki, 889-1692, Japan

Location

Niigata Cancer Centre

Niigata, Niigata, 951-8566, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, 33 700-8558, Japan

Location

Osaka City University Hospital

Osaka, Osaka, 545-0051, Japan

Location

Osaka University Hospital

Suita-shi, Osaka, 565-0871, Japan

Location

Juntendo University Shizuoka Hospital

Izunokuni-shi, Shizuoka, 22 410-2295, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Related Publications (1)

• Kanakura Y, Shirasugi Y, Yamaguchi H, Koike M, Chou T, Okamoto S, Achenbach H, Wu J, Nakaseko C. A phase 3b, multicenter, open-label extension study of the long-term safety of anagrelide in Japanese adults with essential thrombocythemia. Int J Hematol. 2018 Nov;108(5):491-498. doi: 10.1007/s12185-018-2510-7. Epub 2018 Aug 18.

  PMID: 30121892 RESULT

MeSH Terms

Conditions

Thrombocythemia, Essential

Interventions

anagrelide

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombocytosis; Blood Platelet Disorders; Myeloproliferative Disorders; Bone Marrow Diseases; Hemorrhagic Disorders

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 9, 2011
• Study Start: October 27, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 9, 2021
• Results First Posted: June 8, 2016

Record last verified: 2021-05

Locations

JP (16)