Status:
COMPLETED
Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients
Lead Sponsor:
Genexine, Inc.
Collaborating Sponsors:
Symyoo
Conditions:
Total Thyroidectomy
Near-total Thyroidectomy
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed as a combination of phase 1 (Part A) and phase 2 (Part B). The purpose of Part A was to determine the safety, tolerability, and pharmacokinetics in patients with total thyroidec...
Detailed Description
Recombinant human TSH was developed to provide TSH stimulation without withdrawal of thyroid hormone. Radioiodine ablation and diagnosis with rhTSH became the standard of care treatment for patients w...
Eligibility Criteria
Inclusion
- Subjects who voluntarily consented, after listing enough explanation for this study and investigational product.
- Minimum 19 years old.
- Minimum 50kg of body weight.
- Patients who had undergone total thyroidectomy or near total thyroidectomy due to differentiated thyroid carcinoma.
- Patient undergoing thyroid hormone administration.
Exclusion
- Thyroid cancer excluding differentiated thyroid carcinoma.
- Thyroidectomy excluding total thyroidectomy and near total thyroidectomy.
- Patients with heart, renal, or liver failure.
- Patients with ischemic stroke or the history of ischemic stroke.
- Smoker or Ex-smoker with less than 3 months of stopping
- Patients with migraine or the history of migraine.
- Patients that the researchers do not think fit into the group, including patients failed in compliance assessment
Key Trial Info
Start Date :
September 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03276988
Start Date
September 7 2017
End Date
January 20 2020
Last Update
September 9 2020
Active Locations (5)
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1
Pusan National University Hospital
Busan, South Korea, 49241
2
Korea University Anam Hospital
Seoul, South Korea, 02841
3
Seoul Asan Medical Center
Seoul, South Korea, 05505
4
Seoul St. Mary's Hospital
Seoul, South Korea, 06591