Switch 2

• Research type

  Research Study

• Full title

  A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) from Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) in Virologically Suppressed Chronic Hepatitis B Subjects with Renal and/or Hepatic Impairment

• IRAS ID

  233083

• Contact name

  Kosh Agarwal

• Contact email

  kosh.agarwal@kcl.ac.uk

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2016-004625-16

• Clinicaltrials.gov Identifier

  NCT03180619

• Clinicaltrials.gov Identifier

  115561, IND number

• Duration of Study in the UK

  3 years, 2 months, 27 days

• Research summary

  This is an open-label, multicentre, two-part phase 2 study to evaluate the safety and efficacy of switching to the study medication, tenofovir alafenamide (TAF), from a standard of care medication, tenofovir disoproxil fumarate (TDF), and/or other antiviral treatments. The patient population will include those with chronic hepatitis B with damage to the liver or kidneys who are already taking medication to suppress the virus.

  Chronic Hepatitis B (HBV) is one of the global, principal causes of chronic liver disease, liver damage and liver cell cancer. It is easily transmissible and following HBV infection, 5-10% adults and 90% children fail to produce an immune response adequate to clear the infection. Currently, oral antiviral (OAV) agents are the most successful approved methods of treatment. In contrast to other OAV agents, patient resistance to TDF has not been documented in 8 years of use. TAF is similar to TDF, but more stable in plasma and with a distinct metabolism which offers potential for an improved safety profile in comparison to TDF.

  It is expected that approximately 120 male and female participants aged 18 years or older will be enrolled in the study, in approximately 60 sites in North America, Europe and the Asia Pacific regions. Part 1 of the study will enrol roughly 90 patients that have different stages of kidney damage and Part 2 of the study will enrol roughly 30 patients with either moderate or severe liver damage. Study medication treatment will last 96 weeks and participants will attend about 11 study visits.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  17/LO/1673

• Date of REC Opinion

  1 Dec 2017

• REC opinion

  Further Information Favourable Opinion