GS-7340 & TDF in Treatment-Naive Adults with CHB

• Research type

  Research Study

• Full title

  A Phase 1b Randomized, Open Label, Active- Controlled Study to Assess the Safety, Viral Kinetics and Anti- HBV Activity of GS-7340 in Treatment- Naïve Adults with Chronic Hepatitis B (CHB) Infection.

• IRAS ID

  92273

• Contact name

  Graham Foster

• Sponsor organisation

  Gilead Sciences, Inc

• Eudract number

  2011-004586-33

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a Gilead sponsored study, in patients with chronic Hepatitis B virus (HBV). Hepatitis B virus (HBV) is a deoxyribonucleic acid (DNA) virus that infects approximately 350 million people worldwide. Participants will be eligible to take part in this trial if they are infected with chronic HBV who are HBeAg() or HBeAg(-) and are naÇîve to anti-HBV treatment. Enrolment will be stratified by HBeAg status with approximately 1:1 distribution resulting in approximately 25 HBeAg and 25 HBeAg- subjects. Study participants will be randomly allocated 1:1:1:1:1 to receive one of the following treatments orally once daily under fasted conditions:GS7340: 8mg, 25mg, 40mg or 120mg or Tenofovir disoproxil fumurate TDF-300mg Participants will be housed for at least the first 72 hours post first dose. Serum HBV DNA levels will be measured at all visits starting at screening. Participants will receive treatment for a 28 day period with observed in clinic study drug dosing on days 1-3, 5,8,10,15,19 and 22.The main objective of this study is to evaluate the differences in short-term antiviral activity between doses of GS-7340 (8mg, 25mh, 40mg and 120mg) with respect to time weighted average change from Baseline through Week 4 (DAVG4) in serum HBV DNA (log10IU/ml).Approximately 50 patients from the UK, New Zealand, Canada and Australia will take part in this study. Patients will be recruited from hospital clinical and they will be required to attend regular visits to receive treatment, be examined by the study doctor and will be followed up for safety for 30 days post treatment. It is not guaranteed that this study will provide the patient with benefits or that it may better their health/ condition. However it is hoped that this study will contribute further information towards treatment in patients with HBV in the future. Note: The IRAS system does not allow superscript to subscript figures to be added in the text as follows: 2X105- 5 should be in format superscript 2X104- 4 should be in format superscript Measurements are affected ie 100,000mm3- 3 should be the format superscript. DAVG4- 4 should be in the format subscript. log10 IU/mL- the 5 should be in format superscript CLCR- CR should be in format subscript.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/SC/0531

• Date of REC Opinion

  23 Jan 2012

• REC opinion

  Further Information Favourable Opinion