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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-30

Study Completion Date

2019-04-09

Brief Summary

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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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Detailed Description

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Conditions

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Parathyroid Carcinoma Primary Hyperparathyroidism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KHK7580

oral administration

Group Type EXPERIMENTAL

KHK7580

Intervention Type DRUG

oral administration

Interventions

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KHK7580

oral administration

Intervention Type DRUG

Other Intervention Names

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evocalcet

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No