HH-003 / Huahui Health - LARVOL DELTA

A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection (clinicaltrials.gov) - P2b | N=80 | Recruiting | Sponsor: Huahui Health | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia (clinicaltrials.gov) - P2a | N=75 | Active, not recruiting | Sponsor: Huahui Health | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection (clinicaltrials.gov) - P2a | N=9 | Terminated | Sponsor: Huahui Health | Active, not recruiting ➔ Terminated; During the study, the sponsor adjusted the overall clinical development strategy, decided to terminate the enrollmentin advance after discussion with the lead investigator.

Trial termination • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors (clinicaltrials.gov) - P2a | N=73 | Completed | Sponsor: Huahui Health | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Safety and efficacy of anti-pre-S1 domain monoclonal antibody (HH-003) treatment in patients with co-infection of chronic hepatitis B virus (HBV) and hepatitis D virus (HDV): a single center, open-label, phase 2 trial (EASL-ILC 2023) - P2a | "HH-003 treatment at a dose of 20 mg/kg demonstrated significant decrease of HDV RNA level and ALT normalization, with a good safety profile in participants co-infected with HBV and HDV. HH-003 might provide a new treatment option for patients with HBV and HDV co-infection, and a large-scale study will be conducted to further demonstrate such a promising anti-viral effect of HH-003 in patients with HBV and HDV co-infection. Figure: Efficacy outcomes from the study."

Clinical • Late-breaking abstract • P2 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection (clinicaltrials.gov) - P2b | N=80 | Not yet recruiting | Sponsor: Huahui Health

New P2b trial • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors (clinicaltrials.gov) - P2a | N=73 | Active, not recruiting | Sponsor: Huahui Health

New P2a trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia (clinicaltrials.gov) - P2a | N=75 | Recruiting | Sponsor: Huahui Health

New P2a trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection (clinicaltrials.gov) - P2a | N=9 | Active, not recruiting | Sponsor: Huahui Health

New P2a trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A FIRST-IN-PATIENT PHASE IB STUDY OF A HEPATITIS B VIRUS (HBV) NEUTRALIZING ANTIBODY HH-003 IN TREATMENT NAà VE PARTICIPANTS WITH HBEAG-POSITIVE CHRONIC HBV INFECTION (AASLD 2022) - "HH-003 was safe and well-tolerated, and demonstrated a dose-dependent PK profile in the treatment naïve, HBeAg-positive CHB participants. Three doses of 20 mg/kg of HH-003 resulted in optimum dose exposure and antiviral activity in immune active participants."

Clinical • Late-breaking abstract • P1 data • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation

A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1 | N=68 | Completed | Sponsor: Huahui Health

New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation