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To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHK7580 | Experimental | oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK7580 | Drug | oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase. | up to 24 weeks | |
| Serum Corrected Ca Level | up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka City University Hospital | ÅŒsaka | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | KHK7580 (2-24 mg) | KHK7580 was orally administered daily for up to week 52. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KHK7580 (2-24 mg) | KHK7580 was orally administered daily for up to week 52. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase. | Posted | Count of Participants | Participants | Up to 24 weeks |
|
|
up to 52week
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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 | KHK7580 (2-24 mg) | KHK7580 was orally administered daily for up to week 52. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| enterocolitis | Gastrointestinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA ver21.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research & Development Planning Department, Research & Development Division | Kyowa Kirin Co., Ltd. | +81-3-5205-7200 | clinical.info.jp@kyowakirin.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2018 | May 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010282 | Parathyroid Neoplasms |
| D049950 | Hyperparathyroidism, Primary |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| C000631688 | evocalcet |
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| Serum Intact Parathyroid Hormone Level | up to 52 weeks |
| Serum Whole Parathyroid Hormone Level | up to 52 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| serum corrected Ca conc. | Mean | Standard Deviation | mg/dL |
|
| serum intact Parathyroid Hormone conc. | Mean | Standard Deviation | pg/mL |
|
| parathyroid carcinoma | Count of Participants | Participants |
|
| Unable to undergo parathyroidectomy | Number | participants |
|
| Relapse after parathyroidectomy | Number | participants |
|
| previous cinacalcet use | Number | participants |
|
| Pharmacotherapy for primary diseases | Number | participants |
|
| parathyroidectomy | Number | participants |
|
| Parathyroid intervention therapy | Number | participants |
|
|
| Secondary | The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase. | Posted | Count of Participants | Participants | up to 24 weeks |
|
|
|
| Secondary | Serum Corrected Ca Level | Posted | Mean | Standard Deviation | mg/dL | up to 52 weeks |
|
|
|
| Secondary | Serum Intact Parathyroid Hormone Level | Posted | Mean | Standard Deviation | pg/dL | up to 52 weeks |
|
|
|
| Secondary | Serum Whole Parathyroid Hormone Level | Posted | Mean | Standard Deviation | pg/dL | up to 52 weeks |
|
|
|
| 18 |
| 3 |
| 18 |
| 18 |
| 18 |
| urinary tract infection | Renal and urinary disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| uterine cancer | Reproductive system and breast disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Cataract cortical | Eye disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Hangover | General disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA ver21.1 | Non-systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA ver21.1 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA ver21.1 | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA ver21.1 | Non-systematic Assessment |
|
| Radiation sickness syndrome | Injury, poisoning and procedural complications | MedDRA ver21.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA ver21.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA ver21.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA ver21.1 | Non-systematic Assessment |
|
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| D004700 |
| Endocrine System Diseases |
| D010279 | Parathyroid Diseases |
| D006961 | Hyperparathyroidism |