A Prospective, Open-label, Dose Escalation,(Phase 1); Prospective, Randomized, Evaluator Blinded, Active-controlled, 2-sequence, 2-period, 2-treatment, Crossover(Phase 2); Phase 1/2 Clinical Trial to Evaluate the Tolerability, Pharmacokinetics, Safety and Efficacy of GX-30 Administered Intramuscularly in Patients Underwent Total Thyroidectomy or Near Total Thyroidectomy
| Registry | NCT03276988 |
|---|---|
| Status | Completed |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; randomized, crossover, masking: double, diagnostic |
| Enrollment | 8 (Actual) |
| Sponsor | Genexine, Inc. (Industry); collaborators: Symyoo |
| Conditions | Total Thyroidectomy, Near-total Thyroidectomy |
| Interventions | Period 1 GX-30, Period 2 THYROGEN®, Period 1 THYROGEN®, Period 2 GX-30 (Drug) |
| Dates | start 2017-09-07, primary completion 2020-01-20, completion 2020-01-20, first posted 2017-09-08, last updated 2020-09-09 |
| Locations | 5 sites in South Korea |
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All trials for Total Thyroidectomy All trials for Near-total Thyroidectomy All trials of Period 1 GX-30, Period 2 THYROGEN® All trials of Period 1 THYROGEN®, Period 2 GX-30
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®.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Part B - Sequence A | Other | Drug: Period 1 GX-30, Period 2 THYROGEN® | Period 1 GX-30 0.9mg x 2 (Day 1 and Day 2), IM injection. Period 2 THYROGEN® 0.9mg x 2 (Day 1 and Day 2), IM injection |
| Part B - Sequence B | Other | Drug: Period 1 THYROGEN®, Period 2 GX-30 | Period 1 THYROGEN® 0.9mg x 2 (Day 1 and Day 2), IM injection. Period 2 GX-30 0.9mg x 2 (Day 1 and Day 2), IM injection |
Sex: All, ages: 19 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Pusan National University Hospital | Busan | South Korea | |
| Korea University Anam Hospital | Seoul | South Korea | |
| Seoul Asan Medical Center | Seoul | South Korea | |
| Seoul St. Mary's Hospital | Seoul | South Korea | |
| Ajou University Hospital | Suwon | South Korea |