Treatment of Graves’ Orbitopathy (GO) with ATG-Fresenius: A prospective, randomized, open, controlled phase II study to assess the efficacy and safety of an add-on ATG-Fresenius treatment versus a standard steroid treatment

Conditions: Active and moderate to severe Graves’ Orbitopathy

Registration Number: EUCTR2007-005261-35-DE

Lead Sponsor: Fresenius Biotech GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients will be enrolled in this study only if they meet all of the following criteria:
•Signed and dated informed consent form.
•Active and moderate to severe GO.
•Age: 18 – 70 years.
•Patients able to comply with all study related requirements.
•Patients able to receive oral medication.
•Women of childbearing age with a safe contraceptive method throughout the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
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

Patients will not be enrolled in this study if they meet any of the following criteria:
•Women who are pregnant or breast feeding, or with positive urine pregnancy test
•Known Human Immunodeficiency Virus (HIV) infection.
•Unable or unwilling to comply fully with the protocol.
•Confirmed optic neuropathy with major deterioration of visual acuity.
•Patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies.
•Patients with major organ dysfunctions (> threefold of normal values).
•Serious psychiatric or psychological disorders.
•Severe actual viral, bacterial or fungal infection not adequately controlled.
•Thrombocytopenia: < 80,000 thrombocytes/µl.
•Leukopenia: < 4,000 leukocytes/µl.
•Concurrent or previous malignancy.
•Participation in another study of an investigational medicinal product concurrently or within the last 30 days.