Phase 3 study of KHK7580
Phase 3
Completed
- Conditions
- Hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
- Registration Number
- JPRN-jRCT2080223628
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
Evocalcet demonstrated long-term effectiveness in reducing serum cCa concentrations and safety without any unexpected drug related TEAEs in PHPT patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 18
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
- Patients receiving cinacalcet hydrochloride within 2 weeks before screening
- Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Number and percentage of subjects whose corrected serum calcium level is maintained =< 10.3 mg/dL for 2 weeks in the evaluation period.
- Secondary Outcome Measures
Name Time Method efficacy<br>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.