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

Recruiting
18 - 65 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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. 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:

  1. Cirrhosis;
  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.

Study details

Chronic Hepatitis B

NCT06357806

Beijing 302 Hospital

14 June 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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