Clinical Trials List
Protocol NumberALG-000184-202
NCT Number(ClinicalTrials.gov Identfier)NCT06963710
Active
2025-09-23 - 2028-02-13
Phase II
Recruiting8
ICD-10B15.0
Hepatitis A with hepatic coma
ICD-9070.0
Viral hepatitis A with hepatic coma
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)
-
Sponsor
Fortrea Taiwan Co., Ltd.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jing-Houng Wang 無
- 顏毅豪 無
- 盧勝男 無
- 洪肇宏 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蘇東弘 無
- 楊宏志 無
- 曾岱宗 無
- Jia-Horng Kao 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wan-Long Chuang
Co-Principal Investigator
- Ming-Lung Yu 無
- Ming-Lun Yeh 無
- Chung-Feng Huang 無
- Jee-Fu Huang 無
- 梁博程 無
- Chia-Yen Dai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hsin-Yu Kuo 無
- Chiu Hung Chiu 無
- 邱彥程 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic hepatitis B virus (HBV) infection
Objectives
Chronic hepatitis B virus (HBV) infection is a serious liver disease caused by the hepatitis B virus, which replicates its genetic material within the human body.
The objectives of this clinical study are to:
• Evaluate and compare the efficacy of the investigational drug ALG-000184 versus TDF in the treatment of chronic HBV infection.
• Assess the safety and efficacy of ALG-000184.
• Characterize how the investigational drug changes over time and is eliminated from the body (known as pharmacokinetics, or PK assessment).
• Evaluate the effects of the investigational drug on the immune system and compare them with TDF.
• Assess the effects of the investigational drug on biomarkers that indicate disease status.
Test Drug
Film-coated tablet
Film-coated tablet
Film-coated tablet
Active Ingredient
ALG-000184
Tenofovir disoproxil
Tenofovir disoproxil
Dosage Form
116
116
116
Dosage
300 mg
245 mg
245 mg
Endpoints
• Part 1 (HBeAg-positive): Plasma HBV DNA < LLOQ (10 IU/mL; target detected [TD] or target not detected [TND]) at Week 48.
• Part 2 (HBeAg-negative): Plasma HBV DNA < LLOQ (10 IU/mL; TND) at Week 48.
• Part 2 (HBeAg-negative): Plasma HBV DNA < LLOQ (10 IU/mL; TND) at Week 48.
Inclution Criteria
To be eligible for participation, subjects must meet all of the following inclusion criteria at screening:
Able to read the informed consent form, willing to comply with all study procedures, and expected to attend all scheduled study visits.
Male or female, aged 18 to 65 years (inclusive), with a body mass index (BMI) between 18.0 and 35.0 kg/m² (inclusive).
Female subjects must have a negative serum pregnancy test (β-human chorionic gonadotropin [β-hCG]) at screening, and a negative urine pregnancy test at Week –1 (if applicable) and prior to the first dose of the investigational product.
Female subjects must meet one of the following conditions:
a) Postmenopausal: Defined as at least 12 consecutive months without menses for no other medical reason. For women not using hormonal contraception or hormone replacement therapy (HRT), postmenopausal status may be confirmed by elevated follicle-stimulating hormone (FSH) levels within the postmenopausal range.
Note: If there is uncertainty about menopausal status for a woman on HRT who wishes to continue HRT during the study, she must use a highly effective non-estrogen hormonal contraceptive method.
or
b) Permanently sterile: Methods include, but are not limited to, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
or
c) Women of childbearing potential (WOCBP): Eligible only if they and their non-sterilized male partners agree to use a highly effective contraceptive method (either user-dependent or independent) starting from the time of informed consent until at least 90 days after the last dose of the investigational product.
Note: The contraceptive methods used by study participants must comply with local regulatory requirements.
Female subjects must be not pregnant, not breastfeeding, and not planning to become pregnant or donate ova from screening until 90 days after the last dose of the investigational product (or longer if required by local regulations).
Male subjects must use condoms during sexual intercourse from the first dose until at least 90 days after the last dose of the investigational product.
Male subjects must not plan to father a child or donate sperm during the study or within 90 days after the last dose of the investigational product.
Must be HBeAg positive (serum HBeAg ≥ LLOQ) and anti-HBeAg (HBeAb) negative (Part 1), or HBeAg negative (serum HBeAg < LLOQ) (Part 2).
Serum HBsAg ≥ 100 IU/mL.
Plasma HBV DNA ≥ 20,000 IU/mL.
Must have a clinical history of chronic HBV infection (chronic infection and/or chronic hepatitis), with serum ALT ≤ 8 × ULN at screening; ULN defined as 29 U/L for males and 18 U/L for females (WHO 2024).
Must meet one of the following chronic HBV treatment histories at screening:
a) Treatment-naïve (TN): No prior therapy with HBV antivirals (nucleos[t]ide analogs [NA], interferons) or investigational anti-HBV agents including CAMs; or
b) Controlled treatment-naïve (CNT): No therapy with approved (NA, interferons) or investigational HBV antivirals (e.g., antisense oligonucleotides or small interfering RNA [siRNA]) within 6 months or 5 half-lives prior to randomization, whichever is longer.
Note: Subjects with prior CAM treatment experience are excluded.
Able to read the informed consent form, willing to comply with all study procedures, and expected to attend all scheduled study visits.
Male or female, aged 18 to 65 years (inclusive), with a body mass index (BMI) between 18.0 and 35.0 kg/m² (inclusive).
Female subjects must have a negative serum pregnancy test (β-human chorionic gonadotropin [β-hCG]) at screening, and a negative urine pregnancy test at Week –1 (if applicable) and prior to the first dose of the investigational product.
Female subjects must meet one of the following conditions:
a) Postmenopausal: Defined as at least 12 consecutive months without menses for no other medical reason. For women not using hormonal contraception or hormone replacement therapy (HRT), postmenopausal status may be confirmed by elevated follicle-stimulating hormone (FSH) levels within the postmenopausal range.
Note: If there is uncertainty about menopausal status for a woman on HRT who wishes to continue HRT during the study, she must use a highly effective non-estrogen hormonal contraceptive method.
or
b) Permanently sterile: Methods include, but are not limited to, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
or
c) Women of childbearing potential (WOCBP): Eligible only if they and their non-sterilized male partners agree to use a highly effective contraceptive method (either user-dependent or independent) starting from the time of informed consent until at least 90 days after the last dose of the investigational product.
Note: The contraceptive methods used by study participants must comply with local regulatory requirements.
Female subjects must be not pregnant, not breastfeeding, and not planning to become pregnant or donate ova from screening until 90 days after the last dose of the investigational product (or longer if required by local regulations).
Male subjects must use condoms during sexual intercourse from the first dose until at least 90 days after the last dose of the investigational product.
Male subjects must not plan to father a child or donate sperm during the study or within 90 days after the last dose of the investigational product.
Must be HBeAg positive (serum HBeAg ≥ LLOQ) and anti-HBeAg (HBeAb) negative (Part 1), or HBeAg negative (serum HBeAg < LLOQ) (Part 2).
Serum HBsAg ≥ 100 IU/mL.
Plasma HBV DNA ≥ 20,000 IU/mL.
Must have a clinical history of chronic HBV infection (chronic infection and/or chronic hepatitis), with serum ALT ≤ 8 × ULN at screening; ULN defined as 29 U/L for males and 18 U/L for females (WHO 2024).
Must meet one of the following chronic HBV treatment histories at screening:
a) Treatment-naïve (TN): No prior therapy with HBV antivirals (nucleos[t]ide analogs [NA], interferons) or investigational anti-HBV agents including CAMs; or
b) Controlled treatment-naïve (CNT): No therapy with approved (NA, interferons) or investigational HBV antivirals (e.g., antisense oligonucleotides or small interfering RNA [siRNA]) within 6 months or 5 half-lives prior to randomization, whichever is longer.
Note: Subjects with prior CAM treatment experience are excluded.
Exclusion Criteria
Any potential subject meeting any of the following exclusion criteria will be excluded from participation in the study:
Subjects with any current or previous disease that, in the opinion of the investigator, could confound study results, pose additional risk from administration of the investigational product, or prevent, limit, or confound protocol-specified assessments or interpretation of study outcomes.
Subjects with a malignancy within 5 years prior to screening, except for specific cancers cured by surgical resection (e.g., basal cell carcinoma of the skin).
Subjects with a history or clinical evidence of significant or unstable cardiac disease/arrhythmia or clinically significant ECG abnormalities at screening, as assessed by the investigator.
Note: One repeat ECG is allowed for clearly exclusionary screening ECGs (no prior sponsor approval required). Subjects with a normal repeat ECG may be included.
Subjects with severe bone disorders (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondropathy) or multiple fractures.
Clinically significant abnormal vital signs (assessed after resting semi-recumbent or seated for 5 minutes), confirmed upon repeat measurement after an additional 5-minute rest, making the subject unsuitable for participation in the study in the investigator’s opinion.
Physical examination findings considered clinically significant and likely to adversely affect study conduct and/or interpretation, as judged by the investigator.
Subjects who underwent major surgery (e.g., requiring general anesthesia) within 12 weeks prior to screening, who have not fully recovered from surgery, or who plan to undergo surgery during the study participation period or within 12 weeks after the last dose of the investigational product.
Note: Minor procedures under local anesthesia are permitted.
Subjects with any of the following active infections:
a) Hepatitis A virus infection (confirmed by positive anti-HAV IgM).
b) Hepatitis C virus (HCV) infection (confirmed by anti-HCV antibody).
Note: Subjects with negative HCV RNA at screening and documented negative HCV RNA for at least 12 months prior to screening may be included.
c) Hepatitis D virus (HDV) infection (confirmed by anti-HDV antibody).
d) Hepatitis E virus (HEV) infection (confirmed by positive anti-HEV IgM).
e) Human immunodeficiency virus (HIV-1 or HIV-2) infection (confirmed by antibody testing).
f) Any other clinically significant active infection that, in the investigator’s judgment, could interfere with study conduct or data interpretation.
Subjects with clinical evidence of significant liver disease from causes other than HBV, except for Gilbert’s syndrome or metabolic dysfunction-associated steatotic liver disease (MASLD), unless severe steatosis is present (see Exclusion Criterion 13).
Subjects positive for anti-HBs antibody.
Subjects with a history or current evidence of liver cirrhosis.
Notes:
Routine imaging (e.g., liver ultrasound, CT, or MRI) and serum marker panels may be used to rule out advanced fibrosis or cirrhosis.
Regardless of serum marker results, radiologic evidence of cirrhosis is exclusionary.
Subjects with a prior history of cirrhosis (F4) that improved to ≤F3 after long-term HBV treatment will still be excluded.
Subjects with liver fibrosis corresponding to Metavir score ≥ F3, based on:
a) Liver biopsy within 1 year prior to screening or at screening, or
b) FibroScan™ liver stiffness measurement ≥ 8.5 kPa within 6 months prior to or at screening.
Subjects with FibroScan™ controlled attenuation parameter (CAP) score ≥ 290 dB/m within 6 months prior to or at screening.
Subjects with a history or current evidence of hepatic decompensation, such as variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy, or active jaundice.
Subjects with evidence of hepatocellular carcinoma (HCC) on liver ultrasound within 3 months prior to or at screening. If suspicious findings are excluded by contrast-enhanced CT/MRI, the subject may be eligible.
Note: If a liver ultrasound was performed within 3 months before screening showing no evidence of HCC, a repeat screening ultrasound is not required.
Subjects with a history of hypersensitivity or severe allergic reaction to the investigational product, its excipients, and/or any related compounds.
Subjects with a history of drug abuse within 1 year prior to randomization. Subjects without such history but with a positive drug screen at screening may be included with sponsor medical monitor approval.
Excessive alcohol consumption, defined as ≥14 standard drinks per week for women or ≥21 standard drinks per week for men (Chalasani et al., 2018). Refer to the U.S. National Institute on Alcohol Abuse and Alcoholism (NIAAA) for the definition of a standard drink: https://www.niaaa.nih.gov/alcohols-effects-health/what-standard-drink
.
Subjects who have taken or require prohibited medications listed in the protocol within 1 week or 5 half-lives (whichever is longer) prior to the first dose.
Subjects who received an investigational drug or device within 4 weeks (or 5 half-lives, whichever is longer) prior to randomization.
Subjects currently participating in another clinical or interventional study.
Exclusionary laboratory values include:
AST > 8 × ULN, or
Platelet count ≤ 140,000/mm³, or
Total or direct bilirubin > 1.2 × ULN (unless suspected Gilbert’s syndrome), or
INR > 1.2 × ULN, or
Serum albumin below the lower limit of normal, or
Alpha-fetoprotein (AFP) > ULN. Subjects with AFP > ULN but < 50 ng/mL and negative HCC findings on contrast-enhanced CT/MRI may be included, or
eGFR < 70 mL/min/1.73 m² at screening (CKD-EPI equation, unadjusted for African ancestry), or
HbA1c > 8%, or
Any other clinically significant laboratory abnormality as determined by the investigator.
Subjects who are employees of the sponsor, investigator, or study site directly involved in the study, or their immediate family members.
Vulnerable subjects (e.g., individuals who are imprisoned).
Subjects with any current or previous disease that, in the opinion of the investigator, could confound study results, pose additional risk from administration of the investigational product, or prevent, limit, or confound protocol-specified assessments or interpretation of study outcomes.
Subjects with a malignancy within 5 years prior to screening, except for specific cancers cured by surgical resection (e.g., basal cell carcinoma of the skin).
Subjects with a history or clinical evidence of significant or unstable cardiac disease/arrhythmia or clinically significant ECG abnormalities at screening, as assessed by the investigator.
Note: One repeat ECG is allowed for clearly exclusionary screening ECGs (no prior sponsor approval required). Subjects with a normal repeat ECG may be included.
Subjects with severe bone disorders (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondropathy) or multiple fractures.
Clinically significant abnormal vital signs (assessed after resting semi-recumbent or seated for 5 minutes), confirmed upon repeat measurement after an additional 5-minute rest, making the subject unsuitable for participation in the study in the investigator’s opinion.
Physical examination findings considered clinically significant and likely to adversely affect study conduct and/or interpretation, as judged by the investigator.
Subjects who underwent major surgery (e.g., requiring general anesthesia) within 12 weeks prior to screening, who have not fully recovered from surgery, or who plan to undergo surgery during the study participation period or within 12 weeks after the last dose of the investigational product.
Note: Minor procedures under local anesthesia are permitted.
Subjects with any of the following active infections:
a) Hepatitis A virus infection (confirmed by positive anti-HAV IgM).
b) Hepatitis C virus (HCV) infection (confirmed by anti-HCV antibody).
Note: Subjects with negative HCV RNA at screening and documented negative HCV RNA for at least 12 months prior to screening may be included.
c) Hepatitis D virus (HDV) infection (confirmed by anti-HDV antibody).
d) Hepatitis E virus (HEV) infection (confirmed by positive anti-HEV IgM).
e) Human immunodeficiency virus (HIV-1 or HIV-2) infection (confirmed by antibody testing).
f) Any other clinically significant active infection that, in the investigator’s judgment, could interfere with study conduct or data interpretation.
Subjects with clinical evidence of significant liver disease from causes other than HBV, except for Gilbert’s syndrome or metabolic dysfunction-associated steatotic liver disease (MASLD), unless severe steatosis is present (see Exclusion Criterion 13).
Subjects positive for anti-HBs antibody.
Subjects with a history or current evidence of liver cirrhosis.
Notes:
Routine imaging (e.g., liver ultrasound, CT, or MRI) and serum marker panels may be used to rule out advanced fibrosis or cirrhosis.
Regardless of serum marker results, radiologic evidence of cirrhosis is exclusionary.
Subjects with a prior history of cirrhosis (F4) that improved to ≤F3 after long-term HBV treatment will still be excluded.
Subjects with liver fibrosis corresponding to Metavir score ≥ F3, based on:
a) Liver biopsy within 1 year prior to screening or at screening, or
b) FibroScan™ liver stiffness measurement ≥ 8.5 kPa within 6 months prior to or at screening.
Subjects with FibroScan™ controlled attenuation parameter (CAP) score ≥ 290 dB/m within 6 months prior to or at screening.
Subjects with a history or current evidence of hepatic decompensation, such as variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy, or active jaundice.
Subjects with evidence of hepatocellular carcinoma (HCC) on liver ultrasound within 3 months prior to or at screening. If suspicious findings are excluded by contrast-enhanced CT/MRI, the subject may be eligible.
Note: If a liver ultrasound was performed within 3 months before screening showing no evidence of HCC, a repeat screening ultrasound is not required.
Subjects with a history of hypersensitivity or severe allergic reaction to the investigational product, its excipients, and/or any related compounds.
Subjects with a history of drug abuse within 1 year prior to randomization. Subjects without such history but with a positive drug screen at screening may be included with sponsor medical monitor approval.
Excessive alcohol consumption, defined as ≥14 standard drinks per week for women or ≥21 standard drinks per week for men (Chalasani et al., 2018). Refer to the U.S. National Institute on Alcohol Abuse and Alcoholism (NIAAA) for the definition of a standard drink: https://www.niaaa.nih.gov/alcohols-effects-health/what-standard-drink
.
Subjects who have taken or require prohibited medications listed in the protocol within 1 week or 5 half-lives (whichever is longer) prior to the first dose.
Subjects who received an investigational drug or device within 4 weeks (or 5 half-lives, whichever is longer) prior to randomization.
Subjects currently participating in another clinical or interventional study.
Exclusionary laboratory values include:
AST > 8 × ULN, or
Platelet count ≤ 140,000/mm³, or
Total or direct bilirubin > 1.2 × ULN (unless suspected Gilbert’s syndrome), or
INR > 1.2 × ULN, or
Serum albumin below the lower limit of normal, or
Alpha-fetoprotein (AFP) > ULN. Subjects with AFP > ULN but < 50 ng/mL and negative HCC findings on contrast-enhanced CT/MRI may be included, or
eGFR < 70 mL/min/1.73 m² at screening (CKD-EPI equation, unadjusted for African ancestry), or
HbA1c > 8%, or
Any other clinically significant laboratory abnormality as determined by the investigator.
Subjects who are employees of the sponsor, investigator, or study site directly involved in the study, or their immediate family members.
Vulnerable subjects (e.g., individuals who are imprisoned).
The Estimated Number of Participants
-
Taiwan
30 participants
-
Global
194 participants
