A Phase 3 interventional study of Libevitug 20 mg/kg and Libevitug 10 mg/kg in Chronic Hepatitis D Infection, sponsored by Huahui Health. Recruiting at 7 sites in 3 countries. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Huahui Health · Phase 3, Interventional, and Treatment
This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection.
63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.
This study's planned enrollment of 160 is above the median of 80 across 30 interventional studies indexed under Hepatitis D.
Browse Hepatitis D studies →Huahui Health is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive libevitug at a dose of 20 mg/kg Q2W via intravenous infusion for 96 weeks
Drug: Libevitug 20 mg/kg
Participants will receive libevitug at a dose of 10 mg/kg Q2W via intravenous infusion for 96 weeks
Drug: Libevitug 10 mg/kg
Participants will be observed as comparator for 48 weeks, then to receive libevitug 20 mg/kg for 48 weeks
Other: Delayed treatment with libevitug
Proportion of participants with HDV RNA below LLOQ with TND or a decrease of ≥ 2 log10 from baseline, and ALT normalization at Week 48 of the treatment period
Proportion of participants with HDV RNA below Lower Limit of Quantification (LLOQ) with target not detected (TND) or a decrease of ≥ 2 log10 from baseline, and ALT normalization at Week 48 of the treatment period
Time frame: Week 48
Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline, and ALT normalization
Time frame: up to week 96
Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline
Time frame: up to week 96
Proportion of participants with plasma HDV RNA achieving HDV RNA < LLOQ
Time frame: up to week 96
Proportion of participants with ALT normalization
Time frame: up to week 96
Change from baseline in liver stiffness measurement (LSM)
Time frame: up to week 96
Change from baseline in plasma HDV RNA levels at different time points
Time frame: up to week 96
Change from baseline in Model for End-Stage Liver Disease (MELD) score at different time points
Time frame: up to week 96
Change from baseline in Child-Pugh score at different time points during the treatment period, extended treatment period and follow-up period. (A higher Child-Pugh score indicates poorer liver function, more severe disease, and a worse prognosis)
Time frame: up to week 96
Liver related clinical events
Time frame: up to week 120
Percentage of participants with treatment-emergent adverse events (TEAEs)
Time frame: up to week 120
Ctrough,ss
Steady-state trough concentration of libevitug
Time frame: up to week 96
HDV and HBV genotyping
Time frame: baseline
Change from baseline in quality of life assessed with questionnaire (Hepatitis B quality of life instrument (HBQoL) Version 1.0 and Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) version 4.0 ) at all postbaseline assessments
Time frame: up to week 120
Started Apr 2026 (actual). Primary completion is estimated for Sep 2028, 28 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Libevitug