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

September 7, 2020 updated by: Genexine, Inc.

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

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 05505
        • Seoul Asan Medical Center
      • Seoul, Korea, Republic of, 06591
        • Seoul St. Mary'S Hospital
      • Suwon, Korea, Republic of, 16499
        • Ajou University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Part B - Sequence A
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
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.
Other Names:
  • Thyrotropin alpha
Other: Part B - Sequence B
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
Drug: 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.
Other Names:
  • Thyrotropin alpha

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy (Part B)
Time Frame: at each Day 4, period 1 and period 2.
I-123 Whole body scan image classification
at each Day 4, period 1 and period 2.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TSH concentration (Part B)
Time Frame: Baseline, Day 1 to Day 8.
TSH concentration for Pharmacokinetics assessment
Baseline, Day 1 to Day 8.
ADA (Part B)
Time Frame: Baseline, Day 1 and 15 of Period 2
Anti-Drug Antibody detection
Baseline, Day 1 and 15 of Period 2
Tg concentration (Part B)
Time Frame: Baseline, Day 1 to Day 5
Thyroglobulin concentration for secondary efficacy assessment
Baseline, Day 1 to Day 5
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
Baseline, Day 1, 2, 5 of each period and Day 15 of period 2.
Adverse events (Part B)
Time Frame: through study completion, average of 6 weeks.
Safety assessment
through study completion, average of 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genexine, Inc.

Collaborators

Symyoo

Investigators

  • Principal Investigator: Mu Il Kang, M.D., Ph. D., Seoul St. Mary'S Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2017

Primary Completion (Actual)

January 20, 2020

Study Completion (Actual)

January 20, 2020

Study Registration Dates

First Submitted

September 4, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (Actual)

September 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GX30_P1/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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