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Farnesyltransferase Inhibitor

PEG IFN-alfa-2a for Hepatitis Delta (D-LIVR Trial)

Phase 3
Waitlist Available
Research Sponsored by Eiger BioPharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

D-LIVR Trial Summary

This trial will compare two hepatitis C treatments, one with and one without a certain drug. The treatments will be evaluated based on their ability to suppress the virus and normalize alanine aminotransferase levels.

Eligible Conditions
  • Hepatitis Delta

D-LIVR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To compare the composite virologic and biochemical response rate at EOT in patients who receive LNF 50 mg/RTV 100 mg BID with PEG IFN-alfa-2a 180 mcg QW vs patients who receive placebo.
To compare the composite virologic and biochemical response rate at end-of-treatment (EOT) in patients who receive LNF 50 mg/RTV 100 mg BID vs patients who receive placebo.
Secondary outcome measures
To compare the histologic response rate at EOT in patients who receive LNF 50 mg/RTV 100 mg BID vs patients who receive placebo.
To compare the histologic response rate at EOT in patients who receive LNF 50 mg/RTV 100 mg BID with PEG IFN-alfa-2a 180 mcg QW vs patients who receive placebo.
To evaluate the HRQL over a 48-week treatment period in patients who receive LNF 50 mg/RTV 100 mg BID/PEG IFN-alfa-2a 180 mcg QW vs placebo.
+3 more

D-LIVR Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Group 2Experimental Treatment3 Interventions
Lonafarnib 50 mg BID + Ritonavir 100 mg BID + PEG IFN alfa-2a 180 mcg QW
Group II: Group 1Experimental Treatment2 Interventions
Lonafarnib 50 mg BID + Ritonavir 100 mg BID
Group III: Group 3Active Control3 Interventions
placebo Lonafarnib + placebo Ritonavir + PEG IFN-alfa-2a 180 mcg QW
Group IV: Group 4Placebo Group2 Interventions
placebo Lonafarnib + placebo Ritonavir
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritonavir
FDA approved
Lonafarnib
FDA approved
Interferon alfa
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Eiger BioPharmaceuticalsLead Sponsor
21 Previous Clinical Trials
6,898 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Did the FDA clear PEG IFN-alfa-2a for use?

"PEG IFN-alfa-2a is in Phase 3 clinical trials, so there is some data indicating its efficacy and multiple rounds of data affirming its safety. Our team at Power rated PEG IFN-alfa-2a's safety as a 3."

Answered by AI

Are there any vacant slots in this ongoing research project?

"The study, which was posted on December 1st, 2018, as indicated on clinicaltrials.gov, is looking for participants. The 9/30/2021 update was the most recent one as of now."

Answered by AI

Are there any other similar clinical trials that have used PEG IFN-alfa-2a?

"The first study involving PEG IFN-alfa-2a was completed in 1998 at Nova Scotia Cancer Centre. As of now, 942 studies have been completed with 53 more ongoing. The majority of these ongoing studies are located in Los Angeles, California."

Answered by AI

Are there any other hospitals or care facilities conducting this research project within the state?

"This study is being conducted by Ruane Clinical Research Group Inc. at their location in Los Angeles, California. Additionally, University of Rochester Medical Center in Rochester, New york and Central Sooner Research in Norman, Oklahoma are a few of the other 22 sites where this trial is taking place."

Answered by AI

PEG IFN-alfa-2a is typically used to treat which conditions?

"PEG IFN-alfa-2a is a medication used to treat malignancies, hematologic disorders, hutchinson-gilford progeria syndrome, and non-hodgkin's lymphoma, lymphoma, and follicular lymphoma."

Answered by AI

How many total people are included in this experiment?

"400 individuals that fit the bill are needed for this clinical trial. If you are eligible and interested, you can take part in this research out of different locations such as Ruane Clinical Research Group Inc. in Los Angeles, California or University of Rochester Medical Center in Rochester, New york."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a
2018. "Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03719313.
~64 spots leftby Apr 2025
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