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| Name | Class |
|---|---|
| Symyoo | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part B - Sequence A | Other | 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 | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Period 1 GX-30, Period 2 THYROGEN® | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (Part B) | I-123 Whole body scan image classification | at each Day 4, period 1 and period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| TSH concentration (Part B) | TSH concentration for Pharmacokinetics assessment | Baseline, Day 1 to Day 8. |
| ADA (Part B) | Anti-Drug Antibody detection |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating women will be excluded. Women of childbearing potential who agreed to use a medically appropriate conceptional method till 6 months after study completion may be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Mu Il Kang, M.D., Ph. D. | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Busan | 49241 | South Korea | |||
| Korea University Anam Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24255551 | Background | Goel R, Raju R, Maharudraiah J, Sameer Kumar GS, Ghosh K, Kumar A, Lakshmi TP, Sharma J, Sharma R, Balakrishnan L, Pan A, Kandasamy K, Christopher R, Krishna V, Mohan SS, Harsha HC, Mathur PP, Pandey A, Keshava Prasad TS. A Signaling Network of Thyroid-Stimulating Hormone. J Proteomics Bioinform. 2011 Oct 29;4:10.4172/jpb.1000195. doi: 10.4172/jpb.1000195. | |
| 8288703 |
| Label | URL |
|---|---|
| Park DJ. Thyroid and Hydrogen Peroxide. Hanyang Med Rev 2012;32:187-91 | View source |
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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.
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At Part B, Both independent central efficacy assessors and participants will be masked. Investigators will be unmasked. (The Part A was open-label.)
|
| Period 1 THYROGEN®, Period 2 GX-30 | Drug | 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. |
|
|
| Baseline, Day 1 and 15 of Period 2 |
| Tg concentration (Part B) | Thyroglobulin concentration for secondary efficacy assessment | Baseline, Day 1 to Day 5 |
| T3, free T4 concentration (Part B) | Thyroid hormones concentration for pharmacodynamic assessment | Baseline, Day 1, 2, 5 of each period and Day 15 of period 2. |
| Adverse events (Part B) | Safety assessment | through study completion, average of 6 weeks. |
| Seoul |
| 02841 |
| South Korea |
| Seoul Asan Medical Center | Seoul | 05505 | South Korea |
| Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Meier CA, Braverman LE, Ebner SA, Veronikis I, Daniels GH, Ross DS, Deraska DJ, Davies TF, Valentine M, DeGroot LJ, et al. Diagnostic use of recombinant human thyrotropin in patients with thyroid carcinoma (phase I/II study). J Clin Endocrinol Metab. 1994 Jan;78(1):188-96. doi: 10.1210/jcem.78.1.8288703. |
| 11297600 | Background | Torres MS, Ramirez L, Simkin PH, Braverman LE, Emerson CH. Effect of various doses of recombinant human thyrotropin on the thyroid radioactive iodine uptake and serum levels of thyroid hormones and thyroglobulin in normal subjects. J Clin Endocrinol Metab. 2001 Apr;86(4):1660-4. doi: 10.1210/jcem.86.4.7405. |
| 9302303 | Background | Ladenson PW, Braverman LE, Mazzaferri EL, Brucker-Davis F, Cooper DS, Garber JR, Wondisford FE, Davies TF, DeGroot LJ, Daniels GH, Ross DS, Weintraub BD. Comparison of administration of recombinant human thyrotropin with withdrawal of thyroid hormone for radioactive iodine scanning in patients with thyroid carcinoma. N Engl J Med. 1997 Sep 25;337(13):888-96. doi: 10.1056/NEJM199709253371304. |
| 10566623 | Background | Haugen BR, Pacini F, Reiners C, Schlumberger M, Ladenson PW, Sherman SI, Cooper DS, Graham KE, Braverman LE, Skarulis MC, Davies TF, DeGroot LJ, Mazzaferri EL, Daniels GH, Ross DS, Luster M, Samuels MH, Becker DV, Maxon HR 3rd, Cavalieri RR, Spencer CA, McEllin K, Weintraub BD, Ridgway EC. A comparison of recombinant human thyrotropin and thyroid hormone withdrawal for the detection of thyroid remnant or cancer. J Clin Endocrinol Metab. 1999 Nov;84(11):3877-85. doi: 10.1210/jcem.84.11.6094. |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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| ID | Term |
|---|---|
| D057073 | Thyrotropin Alfa |
| ID | Term |
|---|---|
| D013972 | Thyrotropin |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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