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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
  • splenectomy
  • 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