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Compares treatment options for Chronic Hepatitis B Infection
Official title A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)
ClinicalTrials.gov ID: NCT06963710
What this study is testing
What is ALG-000184?
ALG-000184 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic hepatitis b infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2 (or minimun age by local regulatory requirements).
- HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
- HBsAg ≥LLOQ.
- HBV DNA ≥20,000 IU/mL.
- A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.
You likely can't join if
- Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
- Positive for anti-HBs antibodies.
- History or current evidence of cirrhosis.
- Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
- History of, or current evidence of, hepatic decompensation.
- Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
See the full eligibility criteria
- Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2 (or minimun age by local regulatory requirements).
- HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
- HBsAg ≥LLOQ.
- HBV DNA ≥20,000 IU/mL.
- A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.
- Must have the following chronic hepatitis B virus infection treatment status at screening:
- Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM [i.e., Treatment Naïve (TN) people], OR
- Have not been on treatment with approved (NA, interferon) or investigational HBV antiviral medicines (e.g., antisense oligonucleotides or small interfering RNAs) within 6 months or 5 half-lives (whichever is longer)...
- Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
- Positive for anti-HBs antibodies.
- History or current evidence of cirrhosis.
- Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
- History of, or current evidence of, hepatic decompensation.
- Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
- Having received an investigational medicinal product or device within 4 weeks (or 5 half-lives, whichever is longer) before the planned first dose of study drug
- Exclusionary screening laboratory values include:
- Aspartate aminotransferase (AST) \>8×ULN,
- Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected)
- International Normalization Ratio (INR) \>1.2×ULN
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Coronado, California, United States
- Garden Grove, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Pasadena, California, United States
- Rialto, California, United States
- San Francisco, California, United States
- San Jose, California, United States
- Miami, Florida, United States
- Marrero, Louisiana, United States
- Baltimore, Maryland, United States
- Chevy Chase, Maryland, United States
- Boston, Massachusetts, United States
- Manhasset, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Sliven, Bulgaria
- Sofia, Bulgaria
- Stara Zagora, Bulgaria
+ 37 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Coronado, California, United States; Garden Grove, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Pasadena, California, United States and 51 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.