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

Primary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280264
• Other study ID #: 7580-101
• Status: Completed
• Phase: Phase 3
• Start date: August 30, 2017
• Est. completion date: April 9, 2019

Study information

• Verified date: May 2021
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 9, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Hypercalcemia
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Parathyroid Carcinoma
• Parathyroid Neoplasms
• Primary Hyperparathyroidism

Intervention

Drug:
• KHK7580
oral administration

Locations

Country	Name	City	State
Japan	Osaka City University Hospital	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Up to 24 weeks
Secondary	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.		up to 24 weeks
Secondary	Serum Corrected Ca Level		up to 52 weeks
Secondary	Serum Intact Parathyroid Hormone Level		up to 52 weeks
Secondary	Serum Whole Parathyroid Hormone Level		up to 52 weeks