Status:
COMPLETED
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Parathyroid Carcinoma
Primary Hyperparathyroidism
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 parathyroidectom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03280264
Start Date
August 30 2017
End Date
April 9 2019
Last Update
May 27 2021
Active Locations (1)
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1
Osaka City University Hospital
Ōsaka, Japan