The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients (NCT06357806) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients
China45 participantsStarted 2024-05-17
Plain-language summary
This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PD-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 - 65 years old;
. Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
. Treatment with NAs (ETV, TDF or TAF）at least 1 years and continue NAs therapy during screening;
. HBV DNA and HBeAg turn negative after NAs treatment;
. HBsAg ranged 200-1000 IU/ml.
Exclusion criteria
. Cirrhosis;
. platelet count \< 90×10\^9/L, WBC count \< 3.0×10\^9/L, neutrophil count \< 1.3×10\^9/L, ALT \> ULN（40U/L）, total bilirubin \> 2ULN;
. History of or suspicion of hepatocellular carcinoma
. Patients received interferon therapy within 12 months;
. Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
. Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The rate of HBsAg loss at 24 weeks and 48 weeks.
Timeframe: 48 weeks
2
Incidence of treatment-emergent adverse events/serious adverse events