Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
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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.
An Intra-Subject Dose-Adjustment Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism Who Are Unable to Undergo Parathyroidectomy or Relapse After Parathyroidectomy
Actual Study Start Date :
August 30, 2017
Actual Primary Completion Date :
April 9, 2019
Actual Study Completion Date :
April 9, 2019
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The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase. [ Time Frame: Up to 24 weeks ]
Secondary Outcome Measures :
The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase. [ Time Frame: up to 24 weeks ]
Serum Corrected Ca Level [ Time Frame: up to 52 weeks ]
Serum Intact Parathyroid Hormone Level [ Time Frame: up to 52 weeks ]
Serum Whole Parathyroid Hormone Level [ Time Frame: up to 52 weeks ]
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Layout table for eligibility information
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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