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Total ThyroidectomyPhase 1/2NCT03276988

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

A Phase 1/2 study testing Period 1 GX-30, Period 2 THYROGEN® and Period 1 THYROGEN®, Period 2 GX-30 in people with Total Thyroidectomy and Near-total Thyroidectomy, run by Genexine, Inc. at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Total Thyroidectomy, Near-total Thyroidectomy
What is being tested?
Period 1 GX-30, Period 2 THYROGEN® and Period 1 THYROGEN®, Period 2 GX-30
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
5 sitesSouth Korea
Study dates
7 Sep 2017to 20 Jan 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • Pusan National University Hospital

    Busan, 49241

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul Asan Medical Center

    Seoul, 05505

  • Seoul St. Mary's Hospital

    Seoul, 06591

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

About this study

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

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®.

Read the 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.

Being tested
Period 1 GX-30, Period 2 THYROGEN®, Period 1 THYROGEN®, Period 2 GX-30
Keywords
Thyroid cancer, Thyroidectomy, rhTSH, GX-30
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Period 1 GX-30, Period 2 THYROGEN®Drug

    Also called Thyrotropin alpha

    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-30Drug

    Also called Thyrotropin alpha

    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.

Study groups in NCT03276988
Study groupRoleWhat they receive
Part B - Sequence AOtherPeriod 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
Receives: Drug: Period 1 GX-30, Period 2 THYROGEN®
Part B - Sequence BOtherPeriod 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
Receives: Drug: Period 1 THYROGEN®, Period 2 GX-30

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy (Part B)

    I-123 Whole body scan image classification

    Measured: at each Day 4, period 1 and period 2.

Secondary outcomes (5)

  1. TSH concentration (Part B)

    TSH concentration for Pharmacokinetics assessment

    Measured: Baseline, Day 1 to Day 8.

  2. ADA (Part B)

    Anti-Drug Antibody detection

    Measured: Baseline, Day 1 and 15 of Period 2

  3. Tg concentration (Part B)

    Thyroglobulin concentration for secondary efficacy assessment

    Measured: Baseline, Day 1 to Day 5

  4. T3, free T4 concentration (Part B)

    Thyroid hormones concentration for pharmacodynamic assessment

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

  5. Adverse events (Part B)

    Safety assessment

    Measured: through study completion, average of 6 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2017
  2. Study start7 Sep 2017
  3. Primary completion20 Jan 2020
  4. Study completion20 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03276988
Sponsor's protocol ID
GX30_P1/2
Status last verified
Sep 2020
First submitted
4 Sep 2017
Last updated
9 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24255551

  • 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.

    PubMed 8288703

  • 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.

    PubMed 11297600

  • 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.

    PubMed 9302303

  • 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.

    PubMed 10566623

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Period 1 GX-30, Period 2 THYROGEN® and Period 1 THYROGEN®, Period 2 GX-30 in people with Total Thyroidectomy and Near-total Thyroidectomy, run by Genexine, Inc. at 5 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy (Part B) (time frame: at each Day 4, period 1 and period 2.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03276988, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.

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