Active — Not RecruitingNot Applicable

The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients

China45 participantsStarted 2024-05-17

Plain-language summary

This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PD-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 18 - 65 years old;
✓. Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
✓. Treatment with NAs (ETV, TDF or TAF）at least 1 years and continue NAs therapy during screening;
✓. HBV DNA and HBeAg turn negative after NAs treatment;
✓. HBsAg ranged 200-1000 IU/ml.

Exclusion criteria

✕. Cirrhosis;
✕. 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;
✕. History of or suspicion of hepatocellular carcinoma
✕. Patients received interferon therapy within 12 months;
✕. Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
✕. Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
✕. Alcohol or drug abuse/dependence;
✕. Investigator judges that the participants are not suitable for this study.

What they're measuring

The rate of HBsAg loss at 24 weeks and 48 weeks.

Timeframe: 48 weeks

Incidence of treatment-emergent adverse events/serious adverse events

Timeframe: 48 weeks

Trial details

NCT IDNCT06357806

SponsorBeijing 302 Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-08

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