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

Phase 3

Completed

• Conditions: Parathyroid Carcinoma; Primary Hyperparathyroidism
• Interventions: Drug: KHK7580

• Registration Number: NCT03280264
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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 parathyroidectomy or relapse after parathyroidectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-30
• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Primary Completion: 2019-04-09
• Study Completion: 2019-04-09
• Results First Submitted: 2021-04-28
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-26
• Last Update Submitted: 2021-05-26
• Results First Posted: 2021-05-27
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KHK7580	KHK7580	oral administration

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serum Corrected Ca Level	up to 52 weeks
Serum Intact Parathyroid Hormone Level	up to 52 weeks
Serum Whole Parathyroid Hormone Level	up to 52 weeks
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

Trial Locations

Locations (1)

Osaka City University Hospital; 🇯🇵 Ōsaka, Japan