Chronic HBV Infection Clinical Trial
Official title:
A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 in Nucleos(t)Ide Analogues-treated Chronic Hepatitis B Subjects With Low-Level Viremia
Verified date | September 2023 |
Source | Huahui Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV.
Status | Active, not recruiting |
Enrollment | 75 |
Est. completion date | March 31, 2024 |
Est. primary completion date | April 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Signed informed consent form; - Male or female aged from 18 to 60 years (inclusively); - 18 kg/m^2=BMI=30 kg/m^2, body weight=50 kg for men and =45 kg for women; - Subjects who have chronic HBV infection greater than or equal to 6 months at screening; - 10 IU/mL=HBsAg=3000 IU/mL; HBV DNA=2000 IU/mL; ALT=3×ULN; - Subjects who have been on nucleoside reverse transcriptase inhibitors therapy for more than 1 year prior to screening. Exclusion Criteria: - Females who are pregnant or lactating at screening; - History of alcoholic liver disease, moderate fatty liver, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection; - History of cirrhosis at any time prior to or at time of screening, or having progressive liver fibrosis at screening ; - History or evidence of hepatocellular carcinoma at any time prior to or at time of screening; - Exclusionary laboratory results at screening: total bilirubin >2xULN or direct bilirubin >1.5xULN,hemoglobin <120 g/L for males or <110 g/L ro females,platelets count<100,000/mm^3 (100×10^9/L), and absolute neutrophils count <1,500/mm^3 (1.5×10^9/L). |
Country | Name | City | State |
---|---|---|---|
China | Beijing Ditan Hospital,Capital Medical University | Beijing | Beijing |
China | Beijing Friendship Hospital,Capital Medical University | Beijing | Beijing |
China | Beijing Youan Hospital,Capital Medical University | Beijing | Beijing |
China | The First Hospital of Jilin University | Changchun | Jilin |
China | Mengchao Hepatobiliary Hospital Of Fujian Medical University | Fuzhou | Fujian |
China | Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong |
China | Shandong Public Health Clinical Center | Jinan | Shandong |
China | The Sixth Peoples Hospital Of Zhengzhou | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Huahui Health |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of subjects with HBV DNA negativation | Week 24 | ||
Primary | Changes from baseline in serum HBsAg | From treatment start up to Week 48 | ||
Secondary | Percentage of subjects achieving maintained virologic response (MVR) | From treatment start up to 48 weeks | ||
Secondary | Duration of MVR | From treatment start up to 48 weeks | ||
Secondary | Percentage of subjects with ALT normalization | From treatment start up to 48 weeks | ||
Secondary | Changes from baseline in serum HBeAg in subjects with positive HBeAg | From treatment start up to 48 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04470388 -
A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment
|
Phase 1 | |
Completed |
NCT05019040 -
Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of PA1010 in HBV Patients
|
Phase 1/Phase 2 | |
Completed |
NCT01943799 -
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
|
Phase 2 | |
Recruiting |
NCT05792761 -
A Study on Antiviral Treatment of Chronic Hepatitis B in Children
|
N/A | |
Completed |
NCT05468060 -
Study of the Safety, Tolerability, Pharmacokinetic Characteristics of PA1010 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04008004 -
A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
|
Phase 1 | |
Completed |
NCT06029634 -
Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients
|
||
Completed |
NCT04147208 -
Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection
|
Phase 2 | |
Completed |
NCT03909191 -
Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage
|
||
Completed |
NCT03664518 -
to Evaluate the Efficacy and Safety of Eltrombopag for Immune Thrombocytopenia With Chronic HBV Infection
|
Phase 2 | |
Completed |
NCT05542979 -
A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection
|
Phase 1 | |
Active, not recruiting |
NCT03903796 -
Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection
|
Phase 3 | |
Completed |
NCT05851261 -
Study to Evaluate the Safety, Tolerance, Pharmacokinetics Characteristics of PA3670 Tablets in Chinese Healthy Subjects
|
Phase 1 |