Phase 3 Study of ITM-014 in patients with thyroid-stimulating hormone-secreting pituitary adenoma

Phase 3

Completed

• Conditions: TSH-secreting pituitary adenoma

• Registration Number: JPRN-jRCT2080223716
• Lead Sponsor: Teijin Pharma Limited

Brief Summary

The thyroid function and tumor size were favorably controlled and clinical symptoms was improved after the start of administration of ITM-014. No new concern on the safety was found.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-15
• Results First Posted: 2021-03-11
• Study Completion: 2021-04-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Main Inclusion Criteria
1. Patients who are diagnosed as TSH-secreting pituitary adenoma
2. Patients who are difficult to perform a surgery for TSH-secreting pituitary adenoma (including patients who are diagnosed necessary by preoperative treatment), patients who do not wish to have a surgery, or patients with postoperative residual tumor

Exclusion Criteria

Main Exclusion Criteria
1. Patients with hypersensitivity to somatostatin analogs
2. Patients with symptomatic cholelithiasis
3. Patients who have a malignant tumor
4. Patients with liver dysfunction or renal dysfunction
5. Patients who have a known or a history of alcoholism or drug addiction
6. Women who are pregnant or breastfeeding, or suspected of being pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified