Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV (LIMT-2)
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|ClinicalTrials.gov Identifier: NCT05070364|
Recruitment Status : Recruiting
First Posted : October 7, 2021
Last Update Posted : March 15, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Hepatitis Delta Virus||Drug: Peginterferon Lambda-1a||Phase 3|
This is a randomized, open-label, parallel arm study that will allocate patients (2:1) with chronic HDV infection to one of two treatment groups: Peginterferon Lambda 180 mcg QW for 48 weeks with 24 weeks follow-up (Arm 1, n=100), or no treatment for 12 weeks followed by Peginterferon Lambda treatment for 48 weeks with 24 weeks of follow-up (Arm 2, n=50). All patients will receive concomitant therapy with a potent 2nd generation anti-HBV nucleos(t)ide analogue (NUC) throughout the study duration.
Data collected during Peginterferon Lambda treatment in Arm 2 will not be included in the primary analysis. The primary purpose of Arm 2 is to provide benchmark data in a parallel reference group for the expected rate of HDV RNA suppression among patients with chronic HDV infection who receive 12 weeks of anti-HBV NUC therapy alone.
Prior to randomization, all patients will enter a run-in phase with 12 weeks of anti-HBV NUC therapy, which will ensure virologic control of HBV (< 100 IU/mL) prior to randomization and start of Peginterferon Lambda therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients With Chronic Hepatitis Delta Virus (HDV) Infection (LIMT-2)|
|Actual Study Start Date :||December 21, 2021|
|Estimated Primary Completion Date :||June 15, 2024|
|Estimated Study Completion Date :||January 15, 2025|
Experimental: Peginterferon Lambda for 48 weeks
Peginterferon Lambda 180 mcg once weekly for 48 weeks with 24 weeks follow-up
Drug: Peginterferon Lambda-1a
No Intervention: No treatment for 12 weeks
No treatment for 12 weeks followed by Peginterferon Lambda 180 mcg once weekly for 48 weeks and 24 weeks follow-up
- Durable Virologic Response [ Time Frame: 72 weeks ]HDV RNA below the limit of quantitation at 24 weeks post-treatment
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Chronic HDV infection documented by a positive HDV antibody test or a positive HDV RNA by RT PCR test for at least 6 months at Screening Visit 2
- Quantifiable HDV RNA by RT-PCR test at Screening Visit 2
- Documented confirmed suppression of HBV DNA (< 100 IU/mL) following at least 12 weeks of anti-HBV NUC treatment with ETV or a TNF-based NUC (TDF or TAF) at Screening Visit 2
- Serum ALT > upper limit of normal (ULN) and < 10 × ULN.
- Patients categorized with Child-Turcotte-Pugh score of ≤ 5 with well compensated liver disease.
- History or current evidence of decompensated liver disease (episodes of bleeding esophageal or gastric varices, ascites and/or encephalopathy)
- Treatment with interferons (IFNs) or immunomodulators within 6 months before Screening Visit 2 or refractory to prior IFN treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05070364
|Contact: Nicole Ramza, MBA||650-272-6138||LIMTfirstname.lastname@example.org|
|Contact: Monica Gangal, MSc||650-272-6138||LIMTemail@example.com|
|Responsible Party:||Eiger BioPharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||October 7, 2021 Key Record Dates|
|Last Update Posted:||March 15, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections