Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients
ConditionChronic Hepatitis B
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing 302 Hospital
About this trial
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.
Eligibility criteria
Qualifiers
1. 18 - 65 years old;
2.Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
3. In virologically suppressed (HBV DNA below the lower detection limit) CHB patients by NAs treatment, HBsAg decreased by less than 0.5log in the last 6 months of Peg-IFNα therapy, and then discontinued Peg-IFNα at least 6 months;
4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 200IU/ml at Peg-IFNα discontinuation and enrollment.
Disqualifiers
1. Cirrhosis;
2.platelet count < 90×109/L, WBC count < 3.0×109/L, neutrophil count < 1.3×109/L, ALT > ULN (40U/L), total bilirubin > 2ULN;
3.History of or suspicion of hepatocellular carcinoma
4.Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
Trial design
Treatments tested in this trial
- Sintilimab
- NAs
- Peg-IFNα-2b
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov