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The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. The study will aim to show that platelet counts can be safely reduced in treated patients to below 600 x 10^9/L after a minimum of three months treatment. To demonstrate an positive effect platelet levels will need to remain below 600 x 10^9/L for at least 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anagrelide Hydrochloride | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anagrelide Hydrochloride | Drug | Subjects will be started at 1.0 mg per day and titrated as necessary. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Responded in Platelet Count | A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With at Least 50% Reduction in Platelet Count | Subjects who achieved at least 50% reduction in platelet count from their baseline level across consecutive visits for at least 4 weeks and following 3 months of treatment. | 12 months |
| Percentage of Subjects With Normalization in Platelet Count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akita University Hospital | Akita | Akita | 05 010-8543 | Japan | ||
| Juntendo University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25160063 | Result | Kanakura Y, Miyakawa Y, Wilde P, Smith J, Achenbach H, Okamoto S. Phase III, single-arm study investigating the efficacy, safety, and tolerability of anagrelide as a second-line treatment in high-risk Japanese patients with essential thrombocythemia. Int J Hematol. 2014 Oct;100(4):353-60. doi: 10.1007/s12185-014-1631-x. Epub 2014 Aug 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anagrelide Hydrochloride | Subjects will be started at 1.0 mg per day orally and titrated as necessary. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Normalization was defined as platelet counts ≤400x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. |
| 12 months |
| Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L | A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. | 12 months |
| Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L | A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. | 12 months |
| Hongo 3-1-3 |
| Bunkyo-ku |
| 13 113-8431 |
| Japan |
| Tokyo Metropolitan Cancer and Infectious diseases Center Kom | Honkomagome 3-18-22 | Bunkyo-ku | 13 113-8677 | Japan |
| Nippon Medical School Hospital | Sendagi 1-1-5 | Bunkyo-ku | 13 113-8603 | Japan |
| Chiba University Hospital | Chuo-ku Inohana 1-8-1 | Chiba-shi | 12 260-8677 | Japan |
| NHO Nagoya Medical Center | Nagoya | Chubu | 23 460-0001 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaidō Prefecture | 01 060-8648 | Japan |
| Juntendo University Shizuoka Hospital | Nagaoka | Izunokuni-shi | 22 410-2295 | Japan |
| Tokai University Hospital | Isehara-shi | Kanagawa | 259-1143 | Japan |
| Osaka City University Hospital | Osaka | Kansai | 27 545-8586 | Japan |
| Gunma University Hospital | Showa-machi 3-39-15 | Maebashi-shi | 10 371-8511 | Japan |
| NHO Tokyo Medical Center | Higashigaoka 2-5-1 | Meguro-ku | 13 152-8902 | Japan |
| Mie University Hospital | Tsu | Mie-ken | 514-8507 | Japan |
| University of Miyazaki Hospital | Miyazaki | Miyazaki | 889-1692 | Japan |
| Niigata Cancer Center Hospital | Chuo-ku Kawagishi-cho 2-15-3 | Niigata-shi | 15 951-8566 | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | 33 700-8558 | Japan |
| Osaka University Hospital | Suita-shi | Osaka | 27 565-0871 | Japan |
| Tokushima University Hospital | Tokushima | Tokushima Perfecture | 770-8503 | Japan |
| Keio University Hospital | Tokyo | 13 160-8582 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anagrelide Hydrochloride |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Who Responded in Platelet Count | A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. | Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment. | Posted | Number | 95% Confidence Interval | percentage of subjects | 12 months |
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| Secondary | Percentage of Subjects With at Least 50% Reduction in Platelet Count | Subjects who achieved at least 50% reduction in platelet count from their baseline level across consecutive visits for at least 4 weeks and following 3 months of treatment. | Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment. | Posted | Number | 95% Confidence Interval | percentage of subjects | 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Normalization in Platelet Count | Normalization was defined as platelet counts ≤400x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. | Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment. | Posted | Number | 95% Confidence Interval | percentage of subjects | 12 months |
|
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| Secondary | Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L | A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. | Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment. | Posted | Number | 95% Confidence Interval | percentage of subjects | 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L | A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. | Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment. | Posted | Number | 95% Confidence Interval | percentage of subjects | 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anagrelide Hydrochloride | 15 | 53 | 53 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOCYTOSIS | Blood and lymphatic system disorders |
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| SPLENOMEGALY | Blood and lymphatic system disorders |
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| PALPITATIONS | Cardiac disorders |
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| CYTOGENETIC ABNORMALITY | Congenital, familial and genetic disorders |
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| VISUAL IMPAIRMENT | Eye disorders |
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| COLONIC POLYP | Gastrointestinal disorders |
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| GASTRIC ULCER | Gastrointestinal disorders |
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| MELAENA | Gastrointestinal disorders |
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| OEDEMA | General disorders |
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| PYREXIA | General disorders |
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| PNEUMONIA | Infections and infestations |
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| PYELONEPHRITIS | Infections and infestations |
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| LACERATION | Injury, poisoning and procedural complications |
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| ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| ALTERED STATE OF CONSCIOUSNESS | Nervous system disorders |
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| HEADACHE | Nervous system disorders |
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| HAEMATURIA | Renal and urinary disorders |
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| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders |
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| CEREBRAL INFARCTION | Vascular disorders |
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| LACUNAR INFARCTION | Vascular disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders |
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| EOSINOPHILIA | Blood and lymphatic system disorders |
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| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders |
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| PALPITATIONS | Cardiac disorders |
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| VERTIGO | Ear and labyrinth disorders |
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| ABDOMINAL DISTENSION | Gastrointestinal disorders |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders |
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| CONSTIPATION | Gastrointestinal disorders |
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| DENTAL CARIES | Gastrointestinal disorders |
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| DIARRHOEA | Gastrointestinal disorders |
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| EPIGASTRIC DISCOMFORT | Gastrointestinal disorders |
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| GASTRITIS | Gastrointestinal disorders |
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| GINGIVAL BLEEDING | Gastrointestinal disorders |
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| NAUSEA | Gastrointestinal disorders |
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| VOMITING | Gastrointestinal disorders |
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| CHEST PAIN | General disorders |
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| FATIGUE | General disorders |
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| MALAISE | General disorders |
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| OEDEMA | General disorders |
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| OEDEMA PERIPHERAL | General disorders |
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| PYREXIA | General disorders |
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| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders |
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| BRONCHITIS | Infections and infestations |
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| CYSTITIS | Infections and infestations |
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| GASTROENTERITIS | Infections and infestations |
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| HERPES ZOSTER | Infections and infestations |
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| NASOPHARYNGITIS | Infections and infestations |
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| PHARYNGITIS | Infections and infestations |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations |
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| CONTUSION | Injury, poisoning and procedural complications |
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| FALL | Injury, poisoning and procedural complications |
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| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations |
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| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations |
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| DEHYDRATION | Metabolism and nutrition disorders |
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| HYPERURICAEMIA | Metabolism and nutrition disorders |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders |
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| BACK PAIN | Musculoskeletal and connective tissue disorders |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders |
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| HEADACHE | Nervous system disorders |
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| HYPOAESTHESIA | Nervous system disorders |
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| POLLAKIURIA | Renal and urinary disorders |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders |
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| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders |
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| HAEMORRHAGE SUBCUTANEOUS | Skin and subcutaneous tissue disorders |
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| RASH | Skin and subcutaneous tissue disorders |
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| HYPERTENSION | Vascular disorders |
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If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D013920 | Thrombocythemia, Essential |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| C021139 | anagrelide |
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| 60 - 69 years |
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| 70 - 79 years |
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| >= 80 years |
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