150 Participants Needed

Peginterferon Lambda for Chronic Hepatitis D

(LIMT-2 Trial)

Recruiting at 94 trial locations
NR
MG
Overseen ByMonica Gangal, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eiger BioPharmaceuticals
Must be taking: Anti-HBV NUCs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in patients chronically infected with HDV. The primary analysis will compare the proportion of patients with HDV RNA \< LLOQ at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of patients with HDV RNA \< LLOQ at the Week 12 visit in the no-treatment comparator group.

Eligibility Criteria

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.

Inclusion Criteria

Serum ALT > upper limit of normal (ULN) and < 10 × ULN.
I have had chronic Hepatitis D for at least 6 months.
My liver is functioning well despite my illness.
See 2 more

Exclusion Criteria

I have never had severe liver problems like bleeding in my stomach or confusion due to liver disease.
I haven't taken interferons or immune system modifiers in the last 6 months.

Timeline

Run-in

Participants receive 12 weeks of anti-HBV NUC therapy to ensure virologic control of HBV prior to randomization

12 weeks

Treatment

Participants receive Peginterferon Lambda 180 mcg once weekly for 48 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Treatment Details

Interventions

  • Peginterferon Lambda-1a
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eiger BioPharmaceuticals

Lead Sponsor

Trials
22
Recruited
8,900+
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