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Hepatitis D, ChronicPhase 2LIMTNCT02765802

A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection

A Phase 2 study testing Peginterferon Lambda-1A in people with Hepatitis D, Chronic, run by EIT Pharma, Inc. at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis D, Chronic
What is being tested?
Peginterferon Lambda-1A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
4 sitesin 3 countries
Study dates
19 Oct 2016to 12 Dec 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic HDV infection of at least 6 months' duration documented by a positive HDV antibody (Ab) test, detectable and quantifiable HDV RNA by qPCR at study entry
  • Serum alanine aminotransferase (ALT) > upper limit of the normal range (ULN) and <10 × ULN at screening
  • Electrocardiogram (ECG) demonstrating no acute ischemia or clinically significant abnormality and a QT interval corrected for heart rate (QTcF) <450 ms for male patients and <460 ms for female patients
  • Thyroid-stimulating hormone (TSH) and/or free T4 within 0.8 to 1.2 × ULN, or adequately controlled thyroid function as assessed by the investigator.
  • Dilated retinal examination ≤1 year before screening
  • Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication

Who cannot join

  • General Exclusions:
  • Participation in a clinical trial with or use of any investigational agent within 30 days before screening, or treatment with interferons (IFNs) or immunomodulators within 12 months before screening
  • Previous use of Lambda. Patients who previously participated in a clinical trial of Lambda but are confirmed to have received placebo or other non-Lambda IFNs are allowed.
  • History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.
  • Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.
  • Exclusions Based on Disease
Show all 49Show fewer
  • Current or previous history of decompensated liver disease (Child-Pugh Class B or C)
  • Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)
  • Past history or current evidence of decompensated liver disease, defined as any of the following at screening:
  • Bilirubin level ≥ 2.5 mg/dL unless due to Gilbert's disease
  • Serum albumin level <3.5 g/dL
  • International normalized ratio (INR) ≥1.5
  • Alpha fetoprotein ≥100 ng/mL
  • Evidence of significant portal hypertension; current presence or history of variceal bleeding, ascites requiring diuretics or paracentesis, or hepatic encephalopathy
  • Any of the following abnormal laboratory test results at screening:
  • Platelet count <90,000 cells/mm^3
  • White blood cell count <3,000 cells/mm^3
  • Absolute neutrophil count <1,500 cells/mm^3
  • Hemoglobin <11 g/dL for women and <12 g/dL for men
  • Serum creatinine concentration ≥1.5× ULN
  • Confirmed creatinine clearance (CrCl) < 50 mL/min by Cockcroft-Gault
  • Evidence of another form of viral hepatitis or another form of liver disease
  • History of hepatocellular carcinoma
  • Patients with any of the following:
  • Current eating disorder or alcohol abuse
  • Excessive alcohol intake
  • In the opinion of the investigator, an alcohol use pattern that will interfere with study conduct
  • Drug abuse within the previous 6 months before screening, with the exception of cannabinoids and their derivatives
  • Prior history or current evidence of any of the following:
  • Immunologically mediated disease
  • Retinal disorder or clinically relevant ophthalmic disorder
  • Any malignancy within 5 years before screening
  • Cardiomyopathy or significant ischemic cardiac or cerebrovascular disease.
  • Chronic pulmonary disease
  • Pancreatitis
  • Severe or uncontrolled psychiatric disorder
  • Active seizure disorder
  • Bone marrow or solid organ transplantation
  • Other significant medical condition that may require intervention during the study
  • Exclusions Based on Concurrent Medication Use
  • Therapy with an immunomodulatory agent
  • Use of telbivudine
  • Current use of heparin or Coumadin
  • Received blood products within 30 days before study randomization
  • Use of hematologic growth factors within 30 days before study randomization
  • Systemic antibiotics, antifungals, or antivirals for treatment of active infection other than HBV within 14 days before study randomization
  • Any prescription or herbal product that is not approved by the investigator
  • Long-term treatment (> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor
  • Receipt of systemic immunosuppressive therapy within 3 months before screening

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Israel2 sites

  • Soroka Medical Center

    Beersheba, 84101

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

Other trials in Israel

New Zealand1 site

  • Auckland City Hospital

    Grafton, Auckland, 1142

Other trials in New Zealand

Pakistan1 site

  • The Aga Khan University and Hospital

    Karachi, 74800

Other trials in Pakistan

About this study

Official title: A Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection (LIMT)

To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV patients.

Read the detailed description

Lambda is the pegylated form of interferon lambda-1a (IFN-λ), a conjugate of recombinant human interleukin 29 (rIL-29) and a linear polyethylene glycol (PEG) chain. IFN-λ and interferon alpha (IFN-α) share the common interferon (IFN)-stimulated gene induction pathway that leads to broad-spectrum antiviral activities. 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 could also induce HDV ribonucleic acid (RNA) decline in patients with CHD. Based on IFN-λ's more limited receptor distribution and previous data from studies involving treatment with IFN-λ in patients with hepatitis B virus (HBV) or hepatitis C virus (HCV), it is postulated that Lambda treatment could be associated with fewer adverse effects than IFN-α treatment. This Phase II study is designed as randomized, open-label study of Lambda 120 or 180 μg subcutaneous (SC) injection weekly for 48 weeks in patients with chronic HDV infection, and the primary objectives of the study are as follows:

  • To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a 48-week treatment period.
  • To evaluate the effect of treatment with 2 different doses of Lambda on HDV RNA levels.
Being tested
Peginterferon Lambda-1A
Medical subject headings
Hepatitis D, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peginterferon Lambda-1ADrug

    Also called Lambda

Study groups in NCT02765802
Study groupRoleWhat they receive
Lambda 180 μgExperimentalLambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.
Receives: Drug: Peginterferon Lambda-1A
Lambda 120 μgExperimentalLambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.
Receives: Drug: Peginterferon Lambda-1A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in HDV Viral Load.

    To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a 48 week treatment period.

    To evaluate the effect of treatment with 2 different doses of Lambda on hepatitis D virus (HDV) ribonucleic acid (RNA) levels.

    Measured: Week 48 (end of treatment)

Secondary outcomes (2)

  1. Change From Baseline in HDV Viral Load

    To evaluate the proportion of patients with undetectable HDV RNA 24 weeks after the end of treatment

    Measured: Week 72 (end of follow-up)

  2. Number of Patients With a Durable Virologic Response

    Durable Virologic Response (DVR) = below the limit of quantitation in HDV RNA at 24 weeks post-treatment

    Measured: Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2016 (estimated)
  2. Study start19 Oct 2016
  3. Primary completion20 Jul 2018
  4. Study completion12 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02765802
Sponsor's protocol ID
EIG-LMD-001
Acronym
LIMT
Status last verified
Dec 2022
First submitted
5 May 2016
Last updated
8 Sep 2026
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kotenko SV, Gallagher G, Baurin VV, Lewis-Antes A, Shen M, Shah NK, Langer JA, Sheikh F, Dickensheets H, Donnelly RP. IFN-lambdas mediate antiviral protection through a distinct class II cytokine receptor complex. Nat Immunol. 2003 Jan;4(1):69-77. doi: 10.1038/ni875. Epub 2002 Dec 16.

    PubMed 12483210

  • Sheppard P, Kindsvogel W, Xu W, Henderson K, Schlutsmeyer S, Whitmore TE, Kuestner R, Garrigues U, Birks C, Roraback J, Ostrander C, Dong D, Shin J, Presnell S, Fox B, Haldeman B, Cooper E, Taft D, Gilbert T, Grant FJ, Tackett M, Krivan W, McKnight G, Clegg C, Foster D, Klucher KM. IL-28, IL-29 and their class II cytokine receptor IL-28R. Nat Immunol. 2003 Jan;4(1):63-8. doi: 10.1038/ni873. Epub 2002 Dec 2.

    PubMed 12469119

  • Wedemeyer H, Manns MP. Epidemiology, pathogenesis and management of hepatitis D: update and challenges ahead. Nat Rev Gastroenterol Hepatol. 2010 Jan;7(1):31-40. doi: 10.1038/nrgastro.2009.205.

    PubMed 20051970

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peginterferon Lambda-1A in people with Hepatitis D, Chronic, run by EIT Pharma, Inc. at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Israel, New Zealand, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HDV Viral Load. (time frame: Week 48 (end of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02765802, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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