RECRUITINGINTERVENTIONAL
Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients
The Safety and Efficacy of Sequential Combination Therapy With PD-1 Antibody and Pegylated Interferon-α in NA-supressed Chronic Hepatitis B Patients
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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;
- 5.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
- 6.Alcohol or drug abuse/dependence;
- 7.Investigator judges that the participants are not suitable for this study.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* 5.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
* 6.Alcohol or drug abuse/dependence;
* 7.Investigator judges that the participants are not suitable for this study.
Treatments Being Tested
DRUG
Sintilimab
100mg/10ml/1bottle
DRUG
NAs
tablets
DRUG
Peg-IFNα-2b
180ug/0.5ml/1bottle
Locations (1)
the Fifth Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China