A Phase 2 interventional study of ALG-000184 and TDF in Chronic Hepatitis B Infection, sponsored by Aligos Therapeutics. Active, not recruiting at 41 sites in 14 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Aligos Therapeutics · Phase 2, Interventional, and Treatment
This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.
This is a randomized, double-blind, active-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of 48 weeks of oral (PO) once daily (QD) monotherapy with ALG-000184 versus TDF in treatment naive (TN) or currently not treated (CNT) HBeAg-positive and HBeAg-negative subjects with chronic HBV infection (inclusive of chronic infection and/or chronic hepatitis).
A total of approximately 200 eligible subjects will be enrolled across 2 study parts. Part 1 will be an evaluation of HBeAg-positive subjects with chronic HBV infection and Part 2 will be an evaluation of HBeAg-negative subjects with chronic HBV infection. Each study part will consist of a main study and an exploratory liver biopsy sub-study.
Following the 48-week double-blind dosing period (Week 48), all participating subjects (in Parts 1 and 2) will be allowed to roll over into a 48 week (i.e., Week 48-96) open-label treatment extension period where they will all receive ALG-000184 monotherapy.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Aligos Therapeutics is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Must have the following chronic hepatitis B virus infection treatment status at screening:
Key Exclusion Criteria:
Exclusionary screening laboratory values include:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.
Drug: ALG-000184
Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.
Drug: TDF
300 mg tablet
300 mg tablet
HBeAg positive: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target detected or target not detected)
HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target detected or target not detected) at Week 48
Time frame: 48 weeks
HBeAg negative: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target not detected)
HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target not detected) at Week 48
Time frame: 48 weeks
Safety and Tolerability
Number of participants with Treatment Emergent Adverse Events (TEAEs), with abnormal 12-lead electrocardiogram readings and abnormal clinical laboratory results.
Time frame: 96 Weeks
HBV DNA levels
Categorized by HBV DNA ≥ Lower Limit of Quantification \[LLOQ\], HBV DNA \<Lower Limit of Quantification \[LLOQ\] (target detected), and HBV DNA \< Lower Limit of Quantification \[LLOQ\] (target not detected)
Time frame: 48 weeks
HBV DNA < lower limit of quantification [LLOQ] (target detected or target not detected) [HBeAg positive]
HBV DNA \< Lower Limit of Quantification \[LLOQ\] (target detected or target not detected) at various time points during the first 48 weeks
Time frame: 48 weeks
HBV DNA < Lower Limit of Quantification [LLOQ] (target not detected) [HBeAg negative]
HBV DNA \< Lower Limit of Quantification \[LLOQ\] (target not detected) at various time points during the first 48 weeks
Time frame: 48 weeks
Change in HBV DNA levels from baseline
Change from baseline in HBV DNA at various time points during the first 48 weeks.
Time frame: 48 weeks
Time to HBV DNA level <Lower Limit of Quantification [LLOQ]
Time to HBV DNA \< Lower Limit of Quantification \[LLOQ\] (target detected or target not detected) (HBeAg positive) and HBV DNA \< Lower Limit of Quantification \[LLOQ\] (target not detected) (HBeAg negative)
Time frame: 96 Weeks
Change in HBV RNA levels from baseline
Change from baseline in HBV RNA levels at various time points during the first 48 weeks
Time frame: 48 weeks
Time to HBV RNA level <Lower Limit of Quantification [LLOQ]
Time to HBV RNA \< Lower Limit of Quantification \[LLOQ\]
Time frame: 96 Weeks
Subjects with abnormal ALT at baseline who have normal ALT at Week 48
Subjects with abnormal ALT at baseline who have normal ALT at Week 48
Time frame: 48 weeks
Emergence of treatment associated mutations in the HBV genome
Emergence of treatment associated mutations in the HBV genome
Time frame: 96 Weeks
PK parameters of ALG-001075
PK parameters of ALG-001075 including the trough plasma concentration (Ctrough)
Time frame: 96 Weeks
PK parameters of ALG-001075
PK parameters of ALG-001075 including the time to reach the maximum plasma concentration (Tmax)
Time frame: 96 Weeks
PK parameters of ALG-001075
PK parameters of ALG-001075 including the maximum drug concentration (Cmax)
Time frame: 96 Weeks
PK parameters of ALG-001075
PK parameters of ALG-001075 including the minimum drug concentration (Cmin)
Time frame: 96 Weeks
PK parameters of ALG-001075
PK parameters of ALG-001075 including the area under the plasma concentration-time curve steady state (AUCss)
Time frame: 96 Weeks
PK parameters of ALG-001075
PK parameters of ALG-001075 including the half-life
Time frame: 96 Weeks
Change in levels of various HBV antigens at various time points from Baseline
Change from baseline in levels of various HBV antigens
Time frame: 96 Weeks
Histologic, virologic, immunologic and/or PK-related endpoints
Change in intrahepatic viral markers (e.g., HBV nucleic acid and antigen levels), immune cell populations, and inflammation/fibrosis biomarkers
Time frame: 96 Weeks
Started Jul 2025 (actual). Primary completion is estimated for Mar 2027, 20 months after the start.
Of 75 industry-sponsored phase 2 interventional studies under Hepatitis B, Chronic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 39. This study's planned 20 months is close to that.
Counting every sponsor, half of 87 studies reached it within 23 months; a quarter within 16 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pevifoscorvir sodium
Aligos Therapeutics