Near-total Thyroidectomy, Total Thyroidectomy
Conditions
Keywords
Thyroid cancer, Thyroidectomy, rhTSH, GX-30
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 thyroidectomy or near total thyroidectomy of GX-30 and it has been completed. The Part B is currently recruiting and will investigate the efficacy and safety of GX-30 compared with THYROGEN®.
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 with differentiated thyroid cancer. Stably supplying rhTSH has been the unmet need for management and follow-up procedure for thyroid remnant. GX-30 is an investigational product, developed to provide inexpensive rhTSH to patients in order to ensure stable supply of rhTSH.
Interventions
DRUGPeriod 1 GX-30, Period 2 THYROGEN®
Part B - Sequence A. GX-30 0.9mg will be administered at Day 1 and Day 2 in Period 1. After wash-out period of 2 to 3 weeks, THYROGEN® 0.9mg will be administered in Period 2.
DRUGPeriod 1 THYROGEN®, Period 2 GX-30
Part B - Sequence B. THYROGEN® 0.9mg will be administered at Day 1 and Day 2 in Period 1. After wash-out period of 2 to 3 weeks, GX-30 0.9mg will be administered in Period 2.
Sponsors
Symyoo
Genexine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
At Part B, Both independent central efficacy assessors and participants will be masked. Investigators will be unmasked. (The Part A was open-label.)
Intervention model description
The Part A (Phase 1) of study has been completed in which 3 single or multiple sequentially assenting doses of GX-30 were investigated. The Part B (Phase 2) is recruiting in current in which each study participant will receive the same multiple doses of GX-30 and THYROGEN® but at different period.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (Part B) | at each Day 4, period 1 and period 2. | I-123 Whole body scan image classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TSH concentration (Part B) | Baseline, Day 1 to Day 8. | TSH concentration for Pharmacokinetics assessment |
| ADA (Part B) | Baseline, Day 1 and 15 of Period 2 | Anti-Drug Antibody detection |
| Tg concentration (Part B) | Baseline, Day 1 to Day 5 | Thyroglobulin concentration for secondary efficacy assessment |
| T3, free T4 concentration (Part B) | Baseline, Day 1, 2, 5 of each period and Day 15 of period 2. | Thyroid hormones concentration for pharmacodynamic assessment |
| Adverse events (Part B) | through study completion, average of 6 weeks. | Safety assessment |
Countries
South Korea
Outcome results
None listed