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Graves' disease patients needed for thyroid clinical study

25 Sep 2019



Illingworth Research Group Ltd is coordinating a phase I study investigating 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. A Safety Review Committee found the drug to have been safe and well-tolerated in patients treated so far.

A further 8 patients with Graves’ disease are needed to complete this study. Travel to and from the study sites is provided from their chosen location, as well as accommodation for patients travelling from far.

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
  • pregnant women and male subjects with pregnant female partners

 

This is not a Society endorsed study. Information has been provided by the Illingworth Research Group Ltd