The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients
NCT ID: NCT06357806
Last Updated: 2024-06-12
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
45 participants
INTERVENTIONAL
2024-06-06
2025-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peg-IFNα group
180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs
Peg-IFNα-2b
180ug/0.5ml/1bottle
NAs
tablets
PD-1 antibody group
1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs
Sintilimab
100mg/10ml/1bottle
NAs
tablets
PD-1 antibody combined Peg-IFNα group
1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs
Sintilimab
100mg/10ml/1bottle
Peg-IFNα-2b
180ug/0.5ml/1bottle
NAs
tablets
Interventions
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Sintilimab
100mg/10ml/1bottle
Peg-IFNα-2b
180ug/0.5ml/1bottle
NAs
tablets
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. Treatment with NAs (ETV, TDF or TAF）at least 1 years and continue NAs therapy during screening;
4. HBV DNA and HBeAg turn negative after NAs treatment;
5. HBsAg ranged 200-1000 IU/ml.
Exclusion Criteria
2. 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;
3. History of or suspicion of hepatocellular carcinoma
4. Patients received interferon therapy within 12 months;
5. Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
6. Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
7. Alcohol or drug abuse/dependence;
8. 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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Central Contacts
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Facility Contacts
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References
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Wang H, Li X, Lu J, Zhang X, Dang S, Li Y, He Y, Guo Y, Wang J, Maimaitijiang W, Zheng S, Ren S, Cao H, Zhang W, Zhang X, Ma H, Wang FS, Fu J. Safety and efficacy of PD-1 antibody combined with pegylated interferon alpha for functional cure in nucleos(t)ide analogues-suppressed chronic hepatitis B patients: protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Sep 21;15(9):e105710. doi: 10.1136/bmjopen-2025-105710.
Other Identifiers
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PIN-CHB-1
Identifier Type: -
Identifier Source: org_study_id
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