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Radioiodine ablation of post-surgical thyroid remnants by recombinant human TSH (rhTSH) in patients with moderately severe and severe Graves' orbithopathy (GO) - Graves' orbithopathy and rhTSH

Radioiodine ablation of post-surgical thyroid remnants by recombinant human TSH (rhTSH) in patients with moderately severe and severe Graves' orbithopathy (GO) - Graves' orbithopathy and rhTSH

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-020855-29-IT
Enrollment
Unknown
Registered
2012-03-02
Start date
2009-10-16
Completion date
Unknown
Last updated
2013-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients affected with moderately severe and severe GO MedDRA version: 14.1 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: HLGT Classification code 10043739 Term: Thyroid gland disorders System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: THYROGEN Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Thyrotropin Concentration unit: mg/ml milligram(s)/millilitre Concentration number: .9-

Sponsors

UNIVERSITA' DEGLI STUDI DI MESSINA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Hyperthyroidism onset15 ml and/or nodular goiter and/or hyperthyroidism relapse during despite anti-thyroid drugs and/or poor compliance to the medical treatment); 4. Moderately severe and severe GO; 5. Clinically active GO (Clinical Activity Score >3/7 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Hyperthyroidism onset >6 months or previously treated by radioiodine or thyroidectomy; 2. GO onset >6 months; 3. Mild GO; 4. Previous GO treatment by glucocorticoids, orbital irradiation or decompressive surgery; 5. Urgent orbital decompressive surgery; 6. Histopathological evidence of thyroid malignancy; 7. Pregnancy or breast-feading

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the overall outcome of GO in terms of improvement, worsening or stability, following radioiodine ablation of post-surgical thyroid remnants, in patients with moderately severe and severe GO, at the end of the follow up period (12 months);Secondary Objective: 1. To evaluate the effects of acute rhTSH administration in GO; 2. To evaluate the overall outcome of GO at 45 days, 3 and 6 months following thyroidectomy/total thyroid ablation; 3. To evaluate changes in the quality of life during and at the end of the follow up period (3, 6 and 12 months);Primary end point(s): Improving moderately severe and severe GO outcome—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026