Clinical Trial: A Study of Lonafarnib With or Without Ritonavir in Patients With HDV

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2b, Open-Label, Randomized Study of the Safety, Tolerability, and Pharmacodynamic Activity of Lonafarnib With or Without Ritonavir in Patients Chronically Infected With Hepatitis Delta Virus (

Brief Summary: A Phase 2b, Open-Label, Randomized Study of the Safety, Tolerability, and Pharmacodynamic Activity of Lonafarnib With or Without Ritonavir in Patients Chronically Infected with Hepatitis Delta Virus

Detailed Summary: This Phase 2b, randomized, open-label study will assess the safety, tolerability, and pharmacodynamics (PD)/efficacy of 48 weeks of lonafarnib (LNF) and ritonavir (RTV) combination therapy vs. LNF monotherapy in patients with chronically infected with Hepatitis Delta Virus (CHD). Sixty patients will be enrolled at a single study site. Eligible patients will have CHD infection (≥ 6 months) confirmed by positive HDV antibody (Ab) test and HDV RNA ≥ 3 lg IU/mL by quantitative polymerase chain reaction (qPCR) at study entry.
Sponsor: Eiger BioPharmaceuticals

Current Primary Outcome: Change from baseline in HDV viral load at Week 72 visit (end of follow-up) [ Time Frame: 72 weeks ]

HDV RNA viral load will be quantified with a real-time qPCR assay with a lower limit of quantification (LLOQ) of 14 IU/mL


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in HDV viral load at Week 48 visit (end of treatment, EOT) [ Time Frame: 48 weeks ]
  • Proportion of patients with histological response [ Time Frame: 72 weeks ]
    Histological response defined as an improvement in liver histology by at least 2 points in the Hepatitis Activity Score (HAI) with improvement or no worsening of the fibrosis score, at the EOT compared with baseline
  • Proportion of patients with sustained virologic response: HDV RNA below the LLOQ 12 weeks after EOT (48 weeks) [ Time Frame: 60 weeks ]
  • Proportion of patients with sustained virologic response: HDV RNA below the LLOQ 24 weeks after EOT (48 weeks) [ Time Frame: 72 weeks ]
  • Number of participants with treatment-emergent changes in clinical laboratory findings [ Time Frame: 48 weeks ]
  • Number of participants with treatment-emergent / treatment-related adverse events (AE) and serious adverse events [ Time Frame: 48 weeks ]
  • Number of participants with AE leading to early discontinuation of study treatment or dose reduction [ Time Frame: 48 weeks ]


Original Secondary Outcome: Same as current

Information By: Eiger BioPharmaceuticals

Dates:
Date Received: November 15, 2016
Date Started: March 2017
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016