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RECRUITINGPhase 2INTERVENTIONAL

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)

A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 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 Virus Infection (B-SUPREME)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Key Who May Qualify: 1. 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). 2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2). 3. HBsAg ≥LLOQ. 4. HBV DNA ≥20,000 IU/mL. 5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening. 6. Must have the following chronic hepatitis B virus infection treatment status at screening: 1. Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM \[i.e., Treatment Naïve (TN) subjects\], OR 2. 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) prior to randomization (i.e., Currently Not Treated (CNT) subjects). Key Who Should NOT Join This Trial: 1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology. 2. Positive for anti-HBs antibodies. 3. History or current evidence of cirrhosis. 4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease. 5. History of, or current evidence of, hepatic decompensation. 6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound. 7. 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 8. Exclusionary screening laboratory values include: 1. Aspartate aminotransferase (AST) \>8×ULN, 2. Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected) 3. International Normalization Ratio (INR) \>1.2×ULN Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria: 1. 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). 2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2). 3. HBsAg ≥LLOQ. 4. HBV DNA ≥20,000 IU/mL. 5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening. 6. Must have the following chronic hepatitis B virus infection treatment status at screening: 1. Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM \[i.e., Treatment Naïve (TN) subjects\], OR 2. 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) prior to randomization (i.e., Currently Not Treated (CNT) subjects). Key Exclusion Criteria: 1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology. 2. Positive for anti-HBs antibodies. 3. History or current evidence of cirrhosis. 4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease. 5. History of, or current evidence of, hepatic decompensation. 6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound. 7. 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 8. Exclusionary screening laboratory values include: 1. Aspartate aminotransferase (AST) \>8×ULN, 2. Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected) 3. International Normalization Ratio (INR) \>1.2×ULN

Treatments Being Tested

DRUG

ALG-000184

300 mg tablet

DRUG

TDF

300 mg tablet

Locations (20)

Aligos Investigational Site
Chandler, Arizona, United States
Aligos Investigational Site
Coronado, California, United States
Aligos Investigational Site
Garden Grove, California, United States
Aligos Investigational Site
Los Angeles, California, United States
Aligos Investigational Site
Palo Alto, California, United States
Aligos Investigational Site
Pasadena, California, United States
Aligos Investigational Site
Rialto, California, United States
Aligos Investigational Site
San Francisco, California, United States
Aligos Investigational Site
San Jose, California, United States
Aligos Investigational Site
Miami, Florida, United States
Aligos Investigational Site
Miami, Florida, United States
Aligos Investigational Site
Marrero, Louisiana, United States
Aligos Investigational Site
Baltimore, Maryland, United States
Aligos Investigational Site
Chevy Chase, Maryland, United States
Aligos Investigational Site
Boston, Massachusetts, United States
Aligos Investigational Site
Manhasset, New York, United States
Aligos Investigational Site
New York, New York, United States
Aligos Investigational Site
Durham, North Carolina, United States
Aligos Investigational Site
Sliven, Bulgaria
Aligos Investigational Sites
Sofia, Bulgaria