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

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Primary Hyperparathyroidism; Parathyroid Carcinoma

Treatments: Drug: KHK7580

Study type: Interventional

Funder types: Industry

Identifiers

NCT03280264

7580-101

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

KHK7580

Experimental group

Description:

oral administration

Treatment:

Drug: KHK7580