EIG-LNF-011 lonafirnib+ritonavir with/without PEG INF-alfa-2a in HDV

• Research type

  Research Study

• Full title

  A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID with and without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared with PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected with Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)ide Therapy (D-LIVR)

• IRAS ID

  255914

• Contact name

  Patrick Kennedy

• Contact email

  p.kennedy@qmul.ac.uk

• Sponsor organisation

  Eiger BioPharmaceuticals, Inc

• Eudract number

  2018-003167-54

• Clinicaltrials.gov Identifier

  NCT03719313

• Duration of Study in the UK

  2 years, 6 months, 7 days

• Research summary

  This study will enrol approximately 400 participants 18 years of age or older, diagnosed with chronic (long-lasting) hepatitis D virus (HDV) infection and willing to take nucleotide/nucleoside inhibitors (entecavir or tenofovir) for the hepatitis B virus (HBV) infection for at least 12 weeks to 6 months before beginning the study treatment. Total time of participation will be up to 2 years.

  This research study is designed to learn more about an investigational drug called lonafarnib that is being developed to treat chronic HDV infection as well as other conditions.
  Lonafarnib will be taken in combination with an approved drug called ritonavir. Ritonavir is commonly used in the treatment of hepatitis C at comparable dosing to what will be used in this study. In this study, ritonavir is used as a “booster” to increase the amount of lonafarnib in the body, to prevent the body breaking down lonafarnib so it can work longer. Additionally, some participants will take an interferon medicine (this medicine is the same as an interferon protein that the body naturally produces) approved for treating HBV and hepatitis C virus (HCV) infections, called peginterferon-alfa-2a (abbreviated as PEG IFN-alfa-2a). PEG IFN-alfa-2a will be a potential added medicine in this study to determine if it improves the treatment outcome when taken with lonafarnib and ritonavir.

  Lonafarnib and ritonavir are taken orally (swallowed) and will be double-blinded using placebo. These two study drugs can be un-blinded if it is important for the safety of the participants.

  For participants assigned to receive PEG IFN-alfa-2a, both the participants and the study doctor will know if the participant is receiving PEG IFN-alfa-2a, as there will be no placebo treatment for PEG IFN-alfa-2a.

  This study will compare 4 groups. Participants will be assigned to one of these 4 groups randomly. Participants will more likely be in Groups A or B (the groups with lonafarnib and ritonavir) than Groups C or D (the groups with placebo).
  A. Lonafarnib taken orally with ritonavir twice daily
  B. Lonafarnib taken orally with ritonavir twice daily with PEG IFN-alfa-2a self-administered once weekly by injection under the skin
  C. Placebo (looks identical to lonafarnib and ritonavir) twice daily with PEG IFN-alfa-2a self-administered once weekly by injection under the skin and
  D. Placebo twice daily

  The purpose of this study is to determine whether the study drugs will reduce the amount of HDV in the blood. Other purposes of this study are to determine the effects of the study drugs on the liver, to determine if taking the study drugs makes quality of life better, and to evaluate the safety of the study drugs.

  The study will be conducted in UK, Belgium, Bulgaria, Canada, France, Germany, Greece, Israel, Italy, Republic of Moldova, New Zealand, Pakistan, Romania, Spain, Switzerland, Taiwan, Turkey, USA and Vietnam.

  The study is anticipated to last until Sep 2021
  Planned start date UK: April 2019
  Last Patientin UK: June/July 2021

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  19/LO/0433

• Date of REC Opinion

  9 May 2019

• REC opinion

  Further Information Favourable Opinion