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Interferon

Peginterferon Lambda for Chronic Hepatitis D (LIMT-2 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
Patients categorized with Child-Turcotte-Pugh score of ≤ 5 with well compensated liver disease.
Documented confirmed suppression of HBV DNA (< 100 IU/mL) following at least 12 weeks of anti-HBV NUC treatment with ETV or a TNF-based NUC (TDF or TAF) at Screening Visit 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights

LIMT-2 Trial Summary

This trial will compare the safety and efficacy of Peginterferon Lambda to no treatment in patients chronically infected with HDV.

Who is the study for?
This trial is for patients with chronic Hepatitis D (HDV) who have been on anti-HBV treatment and have low HBV DNA levels. They should have a certain level of liver enzyme ALT, stable liver function (Child-Turcotte-Pugh score ≤ 5), and no recent use or resistance to interferons.Check my eligibility
What is being tested?
The study tests Peginterferon Lambda-1a's effectiveness over 48 weeks in reducing HDV RNA levels compared to no treatment. After the treatment phase, there's a follow-up period of 24 weeks to assess long-term effects.See study design
What are the potential side effects?
Potential side effects may include flu-like symptoms such as fever, fatigue, headache; blood count changes; muscle or joint pain; and possible injection site reactions.

LIMT-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is functioning well despite my illness.
Select...
My hepatitis B virus levels are low after 12 weeks of specific treatment.

LIMT-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 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
Durable Virologic Response

Side effects data

From 2015 Phase 3 trial • 881 Patients • NCT01598090
59%
Fatigue
48%
Diarrhoea
48%
Pruritus
44%
Rash
41%
Nausea
30%
Headache
30%
Insomnia
19%
Vomiting
19%
Anorectal discomfort
19%
Depression
19%
Rash generalised
15%
Injection site reaction
15%
Anal pruritus
15%
Myalgia
15%
Muscle spasms
11%
Dysgeusia
11%
Injection site rash
11%
Jaundice
11%
Cough
11%
Anaemia
11%
Influenza like illness
11%
Irritability
11%
Hyperbilirubinaemia
7%
Dyspepsia
7%
Dizziness
7%
Upper respiratory tract infection
7%
Pain
7%
Oedema peripheral
7%
Blood bilirubin increased
7%
Alanine aminotransferase increased
7%
Bilirubin conjugated increased
7%
Dyspnoea
7%
Syncope
7%
Pyrexia
7%
Proctalgia
7%
Skin exfoliation
7%
Gastroenteritis
4%
Hyperuricaemia
4%
Decreased appetite
4%
Aspartate aminotransferase increased
4%
Chills
4%
Haemorrhoids
4%
Dry skin
4%
Alopecia
4%
Arthralgia
4%
Overdose
4%
Abdominal pain
4%
Peptic ulcer haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
Part B: Peginterferon Lambda-1a + RBV + TVR
Part B: Peginterferon Alfa-2a + RBV + TVR

LIMT-2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Peginterferon Lambda for 48 weeksExperimental Treatment1 Intervention
Peginterferon Lambda 180 mcg once weekly for 48 weeks with 24 weeks follow-up
Group II: No treatment for 12 weeksActive Control1 Intervention
No treatment for 12 weeks followed by Peginterferon Lambda 180 mcg once weekly for 48 weeks and 24 weeks follow-up
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peginterferon Lambda-1a
2013
Completed Phase 3
~1490

Find a Location

Who is running the clinical trial?

Eiger BioPharmaceuticalsLead Sponsor
21 Previous Clinical Trials
7,155 Total Patients Enrolled

Media Library

Peginterferon Lambda-1a (Interferon) Clinical Trial Eligibility Overview. Trial Name: NCT05070364 — Phase 3
Hepatitis Delta Research Study Groups: Peginterferon Lambda for 48 weeks, No treatment for 12 weeks
Hepatitis Delta Clinical Trial 2023: Peginterferon Lambda-1a Highlights & Side Effects. Trial Name: NCT05070364 — Phase 3
Peginterferon Lambda-1a (Interferon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05070364 — Phase 3

Frequently Asked Questions

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

What is the maximum quota for enrollees in this trial?

"The listing on clinicaltrials.gov verifies that this trial is open for enrollment and actively recruiting patients. The trial was first posted on December 21st, 2021 and last updated November 3rd, 2022. There are 9 different enrolment sites across the country looking for a total of 150 participants."

Answered by AI

In how many hospitals will this study take place?

"Currently, this trial is operational at 9 clinical sites. The locations in and around Los Angeles, San Francisco, and Redwood City as well other cities. To help reduce travel burden for participants, it is best to pick a location that is close to you."

Answered by AI

Are the patients in this clinical trial all over the age of 18?

"This trial is recruiting patients that meet the following age requirements: 18 years or older, and 70 years or younger."

Answered by AI

Which type of patient is this trial designed for?

"This study is looking for approximately 150 individuals who have hepatitis delta virus and are between 18-70 years old."

Answered by AI

Are there significant risks associated with taking Peginterferon Lambda-1a?

"Peginterferon Lambda-1a is a Phase 3 trial drug, which means that while there is data supporting its efficacy, multiple rounds of testing have also verified its safety. Our team has given it a score of 3."

Answered by AI

Can new participants join this trial right now?

"This clinical trial, which was published on December 21st 2021, is currently looking for participants. The information regarding the study has been edited as recently as November 3rd, 2022."

Answered by AI

Are there any existing data sets on the efficacy of Peginterferon Lambda-1a?

"Peginterferon Lambda-1a was first researched in 2020 at Soroka UMC. To date, there have been 13 completed trials with 4 more currently underway; a significant portion of these are located in Los Angeles, California."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV
2021. "Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05070364.
~5 spots leftby Jun 2024
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