Can a new interferon tame hepatitis d?
NCT ID NCT02765802
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether peginterferon lambda, an experimental interferon drug, can safely reduce hepatitis D virus levels in people with chronic infection. Participants receive one of two doses of the drug for 48 weeks, and researchers measure changes in viral load and liver health. The study aims to see if the drug can suppress the virus and whether any benefit lasts after treatment ends.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Peginterferon lambda-1A, an experimental form of interferon given as an injection
- What this could lead to
- If effective, this treatment could offer a new option to control hepatitis D, potentially reducing liver damage and improving long-term outcomes.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not hold in larger studies. Interferons can cause flu-like symptoms, fatigue, and other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
33 people
The number who actually took part.
- Started
-
Oct 2016
- Finished
-
Dec 2018
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: 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 * 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: 1. Bilirubin level ≥ 2.5 mg/dL unless due to Gilbert's disease 2. Serum albumin level \<3.5 g/dL 3. International normalized ratio (INR) ≥1.5 4. 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: 1. Platelet count \<90,000 cells/mm\^3 2. White blood cell count \<3,000 cells/mm\^3 3. Absolute neutrophil count \<1,500 cells/mm\^3 4. Hemoglobin \<11 g/dL for women and \<12 g/dL for men 5. Serum creatinine concentration ≥1.5× ULN 6. 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: 1. Current eating disorder or alcohol abuse 2. Excessive alcohol intake 3. In the opinion of the investigator, an alcohol use pattern that will interfere with study conduct 4. 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: 1. Immunologically mediated disease 2. Retinal disorder or clinically relevant ophthalmic disorder 3. Any malignancy within 5 years before screening 4. Cardiomyopathy or significant ischemic cardiac or cerebrovascular disease. 5. Chronic pulmonary disease 6. Pancreatitis 7. Severe or uncontrolled psychiatric disorder 8. Active seizure disorder 9. 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hepatitis D, chronic are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Auckland City Hospital
Grafton, Auckland, 1142, New Zealand
-
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
-
Soroka Medical Center
Beersheba, 84101, Israel
-
The Aga Khan University and Hospital
Karachi, 74800, Pakistan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new shot help control hepatitis d in people with hepatitis b?
- New antibody could tame dual hepatitis b and d infection
- New pill combo aims to tame hepatitis d in small trial
- Hope for hepatitis delta patients: study seeks to end lifelong treatment
- New hope for hepatitis d: experimental drug enters final testing phase
- New drug combo aims to tame rare liver virus