Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients
NCT ID: NCT06457477
Last Updated: 2024-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-06-15
2025-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PD-1 antibody therapy
Sintilimab
100mg/10ml/1bottle
NAs
tablets
Peg-IFNα-2b
180ug/0.5ml/1bottle
Interventions
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Sintilimab
100mg/10ml/1bottle
NAs
tablets
Peg-IFNα-2b
180ug/0.5ml/1bottle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Beijing 302 Hospital
OTHER
Responsible Party
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Locations
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the Fifth Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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PIN-CHB-2
Identifier Type: -
Identifier Source: org_study_id
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