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Completed

NCT Number: NCT03276988

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

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®.

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Key information

Conditions

Total Thyroidectomy Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Near-total Thyroidectomy Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pusan National University Hospital, Busan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Thyrotropin alpha

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.

Other names: Thyrotropin alpha

Primary outcomes

  1. Efficacy (Part B)

    Time frame: at each Day 4, period 1 and period 2.

    I-123 Whole body scan image classification

Secondary outcomes

  1. TSH concentration (Part B)

    Time frame: Baseline, Day 1 to Day 8.

    TSH concentration for Pharmacokinetics assessment

  2. ADA (Part B)

    Time frame: Baseline, Day 1 and 15 of Period 2

    Anti-Drug Antibody detection

  3. Tg concentration (Part B)

    Time frame: Baseline, Day 1 to Day 5

    Thyroglobulin concentration for secondary efficacy assessment

  4. T3, free T4 concentration (Part B)

    Time frame: Baseline, Day 1, 2, 5 of each period and Day 15 of period 2.

    Thyroid hormones concentration for pharmacodynamic assessment

  5. Adverse events (Part B)

    Time frame: through study completion, average of 6 weeks.

    Safety assessment

Sponsors and collaborators

Lead sponsor

Genexine, Inc.

Industry

Collaborators

  • Symyoo

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 8, 2017
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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