Peginterferon Lambda for Chronic Hepatitis D

(LIMT-2 Trial)

Recruiting at 94 trial locations

Overseen By Monica Gangal, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eiger BioPharmaceuticals

Must be taking: Anti-HBV NUCs

Must not be taking: Interferons, Immunomodulators

Disqualifiers: Decompensated liver disease, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

150 Participants Needed

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.

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

Group I: Peginterferon Lambda for 48 weeks Experimental Treatment 1 Intervention

Peginterferon Lambda 180 mcg once weekly for 48 weeks with 24 weeks follow-up

Group II: No treatment for 12 weeks Active Control 1 Intervention

No treatment for 12 weeks followed by Peginterferon Lambda 180 mcg once weekly for 48 weeks and 24 weeks follow-up

Who Is Running the Clinical Trial?

Eiger BioPharmaceuticals

Lead Sponsor

Trials

22

Recruited

8,900+