Recent Updates
Recently added Catalysts

Thyrogen + Radioiodine

Phase 3

Thyroid Neoplasms | Small molecule | Oncology |Sanofi|Last Updated: Mar 18, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment63
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00196729Comparison of the Safety and Successful Ablation of Thyroid Remnant in Post-thyroidectomized Euthyroid Patients (i.e. Patients Administered Thyrogen) Versus Hypothyroid Patients (no Thyrogen) Following 131I AdministrationPHASE3 COMPLETED 63 — — Dec 1, 2001Sep 1, 2003Mar 18, 2015 - —
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Use of Thyrogen in euthyroid patients undergoing radioiodine remnant ablation with 100 mCi (3.7 GBq) 131I results in a comparable ablation rate to patients undergoing radioiodine remnant ablation in the hypothyroid state with 100 mCi (3.7 GBq) 131I
Safety profile of Thyrogen when used for radioiodine remnant ablation
Secondary Endpoints
QoL in patients treated using Thyrogen
Compare the radioiodine uptake and retention into the thyroid bed in euthyroid patients using Thyrogen and patients treated in the hypothyroid state.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
Interventions
NameTypeDescription
Thyrogen + Radioiodine (131I)DRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 68 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients who were at least 18 years old (male or female). * Patients with newly diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as "T2, N0 or N1, and M0" or as "T1, N1, and M0". * Patients with a total o...

Unlock Eligibility Criteria