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NCT03276988
Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients
Phase 1, PHASE2 trial testing Period 1 GX-30, Period 2 THYROGEN® in Total Thyroidectomy in 8 participants. Completed in 20 January 2020.
20 January 2020
Quick facts
| Lead sponsor | Genexine, Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 8 |
| Start date | 7 September 2017 |
| Primary completion | 20 January 2020 |
| Estimated completion | 20 January 2020 |
| Sites | 5 locations across South Korea |
Drugs / interventions tested
- Period 1 GX-30, Period 2 THYROGEN® — full drug profile →
- Period 1 THYROGEN®, Period 2 GX-30 — full drug profile →
Conditions studied
- Total Thyroidectomy — all drugs for Total Thyroidectomy →
- Near-total Thyroidectomy — all drugs for Near-total Thyroidectomy →
Sponsor
Genexine, Inc. — full company profile →
Who can join
19 and older, any sex, with Total Thyroidectomy or Near-total Thyroidectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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®.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03276988
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Total Thyroidectomy
Currently open trials in the same condition.
- NCT07416149 — Comparing PTeye-assisted Versus Conventional Total Thyroidectomy · NA · recruiting
Other Genexine, Inc. trials
Trials by the same sponsor.
- NCT06490939 — Clinical Trial of Efepoetin Alfa in Healthy Subjects · Phase 1 · completed
- NCT05191784 — GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients · Phase 2 · unknown
- NCT04730427 — Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19 · Phase 1 · terminated
- NCT04915989 — Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals · Phase 1 · completed
- NCT04715997 — Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03276988 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Genexine, Inc.
- Last refreshed: 9 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03276988.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing