⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT03276988

Study Description

Brief 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®.

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.

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, , Korea, Republic of

Contact Details

Name: Mu Il Kang, M.D., Ph. D.

Affiliation: Seoul St. Mary's Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: