Clinical trial for Chronic Hepatitis b
Official title ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection
ClinicalTrials.gov ID: NCT07573943
What this study is testing
What is ASC22?
This is an investigational injectable medicine being studied as a potential treatment for chronic hepatitis B. It is designed to block a protein called PD-L1 to help the immune system recognize and fight the virus.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To see if combining ASC22 with pegylated interferon alfa is safe and helps more patients achieve a functional cure.
- Who it's for
- People with long-term hepatitis B virus infection.
- What's involved
- Participants will receive ASC22 injections along with pegylated interferon alfa shots and regular medical checks.
- Time commitment
- The study duration and specific visit schedule are not listed in the provided text.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Sign the informed consent form before inclusion and be able to complete the study according to the study requirements
- From inclusion to 30 days after the last administration of the study drug, male people or female people of childbearing age are willing to...
- 18-60 years old. The weight of male people is not less than 45 kg, and the weight of female people is not less than 40 kg.
- Serum HBsAg\<100 IU/mL
- HBV DNA\<20 IU/mL
You likely can't join if
- A history of allergy, or who are suspected by the researcher to be allergic to the active ingredient of the drug under study or its excipients
- Use of inhibitors, inducers or substrates of CYP3A4 within 28 days before enrollment
- Systematical use of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before enrollment, or vaccination of live...
- Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires anti-infection...
- Clinically significant acute and chronic liver disease not caused by HBV infection (judged by reseachers)
- Confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal...
See the full eligibility criteria
- Sign the informed consent form before inclusion and be able to complete the study according to the study requirements
- From inclusion to 30 days after the last administration of the study drug, male people or female people of childbearing age are willing to voluntarily take effective contraceptive measures
- 18-60 years old. The weight of male people is not less than 45 kg, and the weight of female people is not less than 40 kg. Body mass index (BMI) is within the range of 18-32 kg/m2
- Serum HBsAg\<100 IU/mL
- HBV DNA\<20 IU/mL
- HBeAg-negative
- A history of allergy, or who are suspected by the researcher to be allergic to the active ingredient of the drug under study or its excipients
- Use of inhibitors, inducers or substrates of CYP3A4 within 28 days before enrollment
- Systematical use of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before enrollment, or vaccination of live attenuated vaccine within 1 month before enrollment
- Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires anti-infection treatment when enrollment
- Clinically significant acute and chronic liver disease not caused by HBV infection (judged by reseachers)
- Confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal varices, splenomegaly, ascites, etc, or evidence of progressive liver...
- Primary liver cancer, or alpha-fetoprotein (AFP) is greater than 50 ug/L or imaging suggests the possibility of malignant liver lesions, or other malignant tumors or a history of other malignant tumors within 5 years...
- A history of pathological fracture or osteoporosis
- Gastrointestinal dysfunction or gastrointestinal diseases that might affect the absorption of oral drugs, such as severe gastric ulcer, erosive gastritis, partial gastrectomy, and persistent gastrointestinal symptoms...
- Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal and other systems
- Major trauma or major surgery within 3 months before enrollment, or planned surgery during the study period
- Blood donation/loss ≥ 400 mL within 3 months before enrollment, or given a blood transfusion within 3 months before enrollment, or blood donation/loss ≥ 200 mL within 1 month before enrollment
- Platelet count\ 2 × ULN, albumin\ 1.5 (unless receiving stable anticoagulant therapy)
- HCV antibody (+), HIV antigen/antibody (+), or treponema pallidum antibody (+) and RPR test (+)
- A history of continuous alcohol abuse within 3 years before enrollment (average daily alcohol consumption exceeds 20 gram)
- A history of drug dependence or drug abuse within 1 year before enrollment
- Those who have participated in clinical trials of other investigational drugs or medical devices and taken investigational drugs or used medical devices within 3 months before enrollment
- Female in suckling period or pregnancy test (+) during screening
- people who are considered by the researcher to have other factors that are not suitable for the study
The study team makes the final eligibility decision.
Where it is enrolling
- Chongqing, Chongqing Municipality, China
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.