Patient recruitment for Phase I Graves’ disease study
21 Jan 2019
Illingworth Research Group Ltd are coordinating a phase I study to investigate a potential new drug, K1-70, developed to treat patients who have Graves’ disease, thyroid cancer, and patients who would benefit from controlling thyroid stimulating hormone receptor activity.
Illingworth Research Group Ltd need a further 8 patients with Graves’ disease to complete this study. For more information, please contact:
- volunteer Services team at the Medicines Evaluation Unit on 0800 655 6553 and quote study MEU 15/304
- recruitment Team at the Royal Liverpool and Broadgreen Clinical research Facility between 8.00am and 4.00pm on 0151 706 4863 and quote study CRU/5464 or text CRU/5464 to 07342065915.
Main Inclusion Criteria:
- age 18-75 years, male or female
- have Graves' disease and are being treated with anti-thyroid medications OR not treated with anti-thyroid medications (due to side-effects) and who are clinically and biochemically euthyroid or hyperthyroid
- have a body mass index (weight [kg]/height [m]2) between 18.5 and 35.0 kg/m2.
Main Exclusion Criteria:
- current or chronic history of liver disease
- history of cancer within the last 5 years except localised skin cancer
- Graves' orbitopathy with clinical activity score >3/7
- evidence of optic neuropathy and/or corneal breakdown
- significant systemic infection
- history of recurrent or current infection
- recently had major surgery or plan major surgery
- had thromboembolic event due to a blood clot in the last 12 months
- have clinically significant laboratory tests
- a clinically significant allergic condition (excluding hay fever)
- currently receiving corticosteroids
- smoke more than 10 cigarettes (or its equivalent) per day
- history of drug abuse.
This is not a Society endorsed study. Information has been provided by the Illingworth Research Group Ltd