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rhTSH Dose-Finding in Post-Thyroidectomy
NCT04137185Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2019
- Primary completion
- Dec 2020
- Countries
- 1
- Sponsor
- Zelgen
- Modality
- Biologic, rProtein (Recombinant Protein), Hormone
- Drugs
- thyrotropin alfa
- Conditions
- differentiated thyroid cancer (DTC)
01
Overview
Phase 2, open-label, single-arm trial of thyrotropin alfa in differentiated thyroid cancer (DTC), sponsored by Zelgen. Primary endpoint: Maximum Tolerated Dose up to 7 days. Started Jun 2019; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
rhTSH Arm
Patients receive rhTSH followed by radioiodine
03
Who it enrols
Patients with differentiated thyroid cancer (papillary, follicular, Hurthle cell) who have undergone total or near-total thyroidectomy and are planned for 131I diagnosis or ablation. Must have suppressed TSH (<= 0.5 mU/L) and no recent exposure to iodine-containing substances.
04
Endpoints
Primary
Maximum Tolerated Dose
Secondary
Maximum Plasma Concentration
Area Under the Curve
Serum Thyroglobulin
Radioiodine Uptake
Adverse Events
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