Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients

Total Thyroidectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276988
• Other study ID #: GX30_P1/2
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 7, 2017
• Est. completion date: January 20, 2020

Study information

• Verified date: September 2020
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Near-total Thyroidectomy
• Total Thyroidectomy

Intervention

Drug:
• Period 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.
• Period 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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul Asan Medical Center	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
Genexine, Inc.	Symyoo

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. doi: 10.4172/jpb.1000195. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (Part B)	I-123 Whole body scan image classification	at each Day 4, period 1 and period 2.
Secondary	TSH concentration (Part B)	TSH concentration for Pharmacokinetics assessment	Baseline, Day 1 to Day 8.
Secondary	ADA (Part B)	Anti-Drug Antibody detection	Baseline, Day 1 and 15 of Period 2
Secondary	Tg concentration (Part B)	Thyroglobulin concentration for secondary efficacy assessment	Baseline, Day 1 to Day 5
Secondary	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.
Secondary	Adverse events (Part B)	Safety assessment	through study completion, average of 6 weeks.

External Links

•   Park DJ. Thyroid and Hydrogen Peroxide. Hanyang Med Rev 2012;32:187-91