Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism

• Status: Completed
• Trial end date: 2019-04-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Co., Ltd; Kyowa Kirin Co., Ltd.
• Treatments: Parathyroid Hormone

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:

• Patients receiving cinacalcet hydrochloride within 2 weeks before screening

• Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.

• Severe heart disease

• Severe hepatic dysfunction

• Uncontrolled hypertension and/or diabetes

• Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening