Clinical trials: Chronic Hepatitis B
Chronic Hepatitis D Infection
Study of Bulevirtide in Participants With Chronic Hepatitis D Infection
The main goal of this study is to collect post marketing data from patients with chronic hepatitis D virus (HDV) infection who are treated with bulevirtide to describe the long-term effects of bulevirtide treatment and evaluate…
- Trial name
- NCT05718700
- Testing
- Bulevirtide
- Where
- 53 sites in Austria, France and 4 more
- Volunteers
- 170 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB).
AB-10-8003 is a randomized, multi-center phase II study to evaluate the efficacy and safety of AHB-137 in subjects with HBeAg-negative CHB under stable NA treatment.
- Trial name
- NCT06550128
- Testing
- AHB-137 (24 weeks), AHB-137 (16 weeks)
- Where
- 6 sites in China
- Volunteers
- 86 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B
This study is a Phase Ib, multicenter randomized, double-blind, dose-escalation, placebo-controlled trial designed to evaluate the safety, tolerability, PK, and PD profiles of multiple-dose ACT500 in participants with metabolic…
- Trial name
- NCT07589400
- Testing
- ACT500 Tablets
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Chronic Hepatitis B
Evaluate TQ-A3334 Combined Nucleoside (Acid) Analogs in the First Treatment/Treatment of Chronic HBV Infection
This study uses random, double -blindness, placebo control, and phase multi -center test design. All subjects who meet the standards receive TQ-A3334 per tablet/placebo nucleoside (acid) analog. A total of 116 subjects are needed.
- Trial name
- NCT06706310
- Testing
- TQA3334 Tablet, Nucleoside (acid) analogs (NAs)
- Where
- 15 sites in China
- Volunteers
- 116 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Chronic Hepatitis B Infection
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)
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.
- Trial name
- B-SUPREME (NCT06963710)
- Testing
- ALG-000184, TDF
- Where
- 41 sites in United States, Bulgaria and 12 more
- Volunteers
- 200 people
- Sponsor
- Aligos Therapeutics
Chronic Hepatitis D
Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).
- Trial name
- NCT07454837
- Testing
- Brelovitug (BJT-778), Bulevirtide
- Where
- 44 sites in Austria, Czechia and 6 more
- Volunteers
- 120 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hepatitis D, Chronic
A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV patients.
- Trial name
- LIMT (NCT02765802)
- Testing
- Peginterferon Lambda-1A
- Where
- 4 sites in Israel, New Zealand and 1 more
- Volunteers
- 33 people
- Sponsor
- EIT Pharma, Inc.
Chronic Hepatitis Delta
Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants.
- Trial name
- NCT07096193
- Testing
- GS-4321
- Where
- 28 sites in United States, Bulgaria and 7 more
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HEPATITIS B CHRONIC
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.
- Trial name
- ELIMINATE-B (NCT06680232)
- Testing
- PBGENE-HBV
- Where
- 7 sites in United States, France and 4 more
- Volunteers
- 45 people
- Sponsor
- Precision BioSciences, Inc.
Chronic Hepatitis D Infection
A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)
This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection.
- Trial name
- NCT07499544
- Testing
- Libevitug 20 mg/kg, Libevitug 10 mg/kg, Delayed treatment with libevitug
- Where
- 7 sites in United States, China and 1 more
- Volunteers
- 160 people
- Sponsor
- Huahui Health
Chronic Hepatitis B Infections
Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment…
- Trial name
- NCT07342868
- Testing
- Pevifoscorvir Sodium (ALG-000184)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Aligos Therapeutics
Chronic Hepatitis B Infection
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
This is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment…
- Trial name
- NCT07342881
- Testing
- Pevifoscorvir Sodium (ALG-000184)
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Chronic Hepatitis B
Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy
This Phase 1b clinical study is a multi-center, open-label, dose escalation, prime only, and prime plus boost therapeutic vaccination study of 2 distinct chimpanzee adenoviral vectors (AdC6 and AdC7), containing parts of…
- Trial name
- NCT06070051
- Testing
- VRON-0200-AdC6, VRON-0200-AdC7, VIR-2218
- Where
- 3 sites in Hong Kong, New Zealand
- Volunteers
- 35 people
- Sponsor
- Virion Therapeutics
Chronic Hepatitis B
Long-term Follow-up Study to Evaluate Participants With Chronic Hepatitis B (CHB) Previously Treated With AHB-137 Injection
This study is a prospective, open-label, multicenter long-term follow-up study to evaluate the durability of virologic response in subjects with chronic hepatitis B previously treated with AHB-137 injection.
- Trial name
- NCT07146100
- Where
- 37 sites in China
- Volunteers
- 200 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Chronic Hepatitis B Liver Fibrosis, DDI (Drug-Drug Interaction)
Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide
The proposed indication for Hydronidone Capsules is chronic hepatitis B-associated liver fibrosis, which in clinical practice typically requires concomitant use with antiviral agents for chronic hepatitis B.
- Trial name
- NCT07295873
- Testing
- Entecavir, Tenofovir Disoproxil Fumarate（TDF）, Tenofovir alafenamide（TAF）
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Chronic Hepatitis B With Hepatic Fibrosis
A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis
This is a single-arm, multicenter, open-label Phase III clinical trial to evaluate the safety and tolerability of high-dose hydronidone capsules in patients with hepatic fibrosis and cirrhosis.
- Trial name
- NCT07343778
- Testing
- Hydronidone Capsules
- Where
- China
- Volunteers
- 337 people
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Chronic Hepatitis B With Hepatic Fibrosis
A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis
This is an open-label, single-arm study designed to collect safety data on hydronidone capsules in patients with chronic hepatitis B virus infection accompanied by liver fibrosis or fatty liver disease accompanied by liver…
- Trial name
- NCT07364448
- Testing
- Hydronidone capsules
- Where
- China
- Volunteers
- 411 people
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Chronic Hepatitis B-related Liver Fibrosis
A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis
This trial employs a single-arm, open-label, multicenter clinical trial design. All study participants who meet the inclusion/exclusion criteria will receive Hydronidone treatment for 4 weeks.
- Trial name
- NCT07417553
- Testing
- Hydronidone capsules
- Where
- China
- Volunteers
- 67 people
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Chronic Hepatitis D Infection
A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection
This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection.
- Trial name
- NCT07762027
- Testing
- ABI-6250
- Where
- 22 sites in France, Georgia and 9 more
- Volunteers
- 80 people
- Sponsor
- Assembly Biosciences
Chronic Hepatitis B
A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
This study is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues.
- Trial name
- NCT06993480
- Testing
- AHB-137
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Ausper Biopharma Co., Ltd.