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Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a

NCT03719313 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2023-04-14

No results posted yet for this study

Summary

Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline.

Conditions

  • Hepatitis Delta Virus

Interventions

DRUG

Lonafarnib

Lonafarnib (LNF) 50 mg BID

DRUG

Ritonavir

Ritonavir (RTV) 100 mg BID

DRUG

PEG IFN-alfa-2a

PEG IFN alfa-2a 180 mcg QW

DRUG

Placebo Lonafarnib

Placebo

DRUG

Placebo Ritonavir

Placebo

Sponsors & Collaborators

  • Eiger BioPharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2022-10-06
Completion
2023-03-24
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Moldova
  • Mongolia
  • New Zealand
  • Pakistan
  • Romania
  • Russia
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03719313 on ClinicalTrials.gov