Actively Recruiting
Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients
Led by Beijing 302 Hospital · Updated on 2024-06-20
50
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.
CONDITIONS
Official Title
Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 65 years old
- Diagnosed with chronic hepatitis B confirmed by blood tests, causes, and clinical examination
- Currently have virologically suppressed chronic hepatitis B with HBV DNA below detection due to nucleos(t)ide analogues treatment
- Experienced less than 0.5 log decrease in HBsAg during the last 6 months of Peg-IFN-alpha therapy and stopped Peg-IFN-alpha at least 6 months ago
- Have HBV DNA negative, HBeAg negative, and HBsAg quantification ≤ 200 IU/ml at the time of Peg-IFN-alpha discontinuation and enrollment
You will not qualify if you...
- Have liver cirrhosis
- Platelet count less than 90 x10⁹/L, white blood cell count less than 3.0 x10⁹/L, neutrophil count less than 1.3 x10⁹/L, alanine aminotransferase (ALT) above 40 U/L, or total bilirubin above twice the upper limit of normal
- History or suspicion of hepatocellular carcinoma
- Received immunosuppressive therapy or other treatments affecting the study within the past 12 months
- Have hepatitis A, C, D, HIV infection, or other active infections
- History of alcohol or drug abuse or dependence
- Considered unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the Fifth Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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