TSH-secreting pituitary adenoma
Conditions
Interventions
investigational material(s)
Generic name etc : Lanreotide Acetate
INN of investigational material : Lanreotide
Therapeutic category code : 249 Other hormone preparations (including antihormone prepara
Sponsors
Teijin Pharma Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria 1. Patients who are diagnosed as TSH-secreting pituitary adenoma 2. Patients who are difficult to perform a surgery for TSH-secreting pituitary adenoma (including patients who are diagnosed necessary by preoperative treatment), patients who do not wish to have a surgery, or patients with postoperative residual tumor
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria 1. Patients with hypersensitivity to somatostatin analogs 2. Patients with symptomatic cholelithiasis 3. Patients who have a malignant tumor 4. Patients with liver dysfunction or renal dysfunction 5. Patients who have a known or a history of alcoholism or drug addiction 6. Women who are pregnant or breastfeeding, or suspected of being pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Primary endpoint Serum TSH levels, serum FT3 levels, serum FT4 levels | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy safety Endpoints Efficacy 1. Size of pituitary tumor 2. Clinical symptoms Safety 1. Adverse events 2. Clinical laboratory tests 3. Vital signs 4. Test for anti-lanreotide antibody | — |
Countries
Japan
Outcome results
None listed