Peginterferon Lambda for Chronic Hepatitis D

(LIMT-2 Trial)

Not currently recruiting at 105 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of Peginterferon Lambda, a type of interferon therapy, for individuals with chronic Hepatitis D, a liver infection caused by the hepatitis D virus. Researchers will compare participants receiving the treatment to those not initially treated to determine if it reduces virus levels in the blood. The trial is suitable for individuals with a confirmed chronic Hepatitis D infection for at least six months who are already on medication to control Hepatitis B. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on anti-HBV NUC treatment for at least 12 weeks before joining. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that Peginterferon Lambda-1a is likely to be safe for humans?

Research has shown that Peginterferon Lambda-1a is generally well-tolerated by patients with hepatitis B and C. This treatment appears to be easier on patients compared to Peginterferon Alfa. Some studies have found that Peginterferon Lambda can help control the virus in hepatitis D, potentially leading to better health outcomes.

However, a later-stage study on Peginterferon Lambda was stopped due to safety concerns. While earlier studies were promising, there may be safety risks that require further investigation.

Prospective trial participants should understand these mixed findings. It is crucial to discuss potential benefits and risks with a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Peginterferon Lambda-1a is unique because it targets the body's immune response more specifically than standard treatments for chronic hepatitis D, like Peginterferon Alfa. Unlike other treatments, Peginterferon Lambda-1a is designed to offer antiviral effects with potentially fewer side effects, thanks to its targeted action on the immune system's interferon receptors. Researchers are excited about this treatment because it could provide a more tolerable and effective option for patients, improving their quality of life while managing the virus.

What evidence suggests that Peginterferon Lambda might be an effective treatment for chronic Hepatitis D?

Research has shown that peginterferon lambda-1a is a potential treatment for chronic hepatitis D. Traditional treatments like IFN-α have achieved some success, but peginterferon lambda may cause fewer side effects. In this trial, one group of participants will receive Peginterferon Lambda for 48 weeks, while another group will have no treatment for 12 weeks, followed by Peginterferon Lambda for 48 weeks. Studies indicate that only about one-third of patients with chronic hepatitis D cleared the virus from their blood with peginterferon lambda. This suggests it can help some people, but the results are limited. Safety concerns arose in a late-stage trial that was stopped. Overall, peginterferon lambda might reduce the virus in some patients, but it may not be effective for everyone, and safety remains a crucial consideration. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10187621/

Treatment of chronic hepatitis D with peginterferon lambda ... PEG IFN-lambda-1a (Lambda) has previously demonstrated a good tolerability profile in HBV and HCV patients compared to PEG IFN-alfa. The goal of Phase 2 LIMT-1 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02765802

A Study to Evaluate Pegylated Interferon Lambda ... Since IFN-α has demonstrated anti-hepatitis delta virus (HDV) activity in patients with chronic hepatitis delta (CHD), it is postulated that pegylated IFN-λ ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36800850/

Treatment of chronic hepatitis D with peginterferon lambda-the ... PEG IFN-lambda-1a (Lambda) has previously demonstrated a good tolerability profile in HBV and HCV patients compared to PEG IFN-alfa. The goal of ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0166354220304095

Effectiveness of pegylated interferon monotherapy in the ... This study showed that peginterferon has limited effectiveness in HDV treatment, since only one-third of chronic HDV patients achieved viral clearance and ...

5. contagionlive.com contagionlive.com/view/late-stage-trial-in-chronic-hepatitis-d-delta-eiger-discontinued-due-to-safety-concerns

Late-Stage Trial in Chronic Hepatitis D Discontinued Due ... The phase 3 LIMT-2 study (NCT05070364) was assessing the efficacy and safety of peginterferon lambda in approximately 160 participants with well ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05070364

NCT05070364 | Phase 3 Study to Evaluate the Efficacy ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12210157/

Hope on the horizon: Emerging therapies for hepatitis D - PMC Despite these limitations, studies have shown that HDV RNA suppression with PEG-IFNα treatment correlates with improved clinical outcomes and a ...