Hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
Conditions
Interventions
investigational material(s)
Generic name etc : KHK7580
INN of investigational material : evocalcet
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Inv
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Personally submitted written voluntary informed consent to participate in the study - Patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy. - Corrected serum calcium level is > 11.3 mg/dL at screening.
Exclusion criteria
Exclusion criteria: - Patients receiving cinacalcet hydrochloride within 2 weeks before screening - Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Number and percentage of subjects whose corrected serum calcium level is maintained =< 10.3 mg/dL for 2 weeks in the evaluation period. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Number and percentage of subjects whose corrected serum calcium level decreases by =< 1.0 mg/dL from baseline and the decrease is maintained for 2 weeks in the evaluation period. | — |
Countries
Japan
Outcome results
None listed