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)

Conditions

• Chronic Hepatitis B Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• ALG-000184 — DRUG
  300 mg tablet
• TDF — DRUG
  300 mg tablet

Study Details

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.

Key Dates

Start date

Jul 15, 2025

Status verified

Apr 2025

Primary completion

Mar 31, 2027

Completion

Aug 31, 2028

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ALG-000184
  Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.
• Active Comparator: TDF
  Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.

Primary Outcome Measure

HBeAg positive: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target detected or target not detected) [ Time Frame: 48 weeks ]

Central Contacts

• Aligos Therapeutics
  (800) 466-6059
  [email protected]

Locations (18)

Find similar trials in Chandler, AZ

Related Studies

• Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
  PHASE1 · Recruiting · Aligos Therapeutics · Orlando, Florida