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Sequential PD-1 Antibody and Pegylated Interferon Therapy for Nucleos(t)Ide Analogue-suppressed Chronic Hepatitis B

ConditionChronic Hepatitis B
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBeijing 302 Hospital

About this trial

This is a prospective, multicenter, randomized, open-label controlled clinical trial designed to evaluate the efficacy and safety of a sequential treatment strategy incorporating a PD-1 antibody and pegylated interferon-α (Peg-IFNα) in patients with chronic hepatitis B receiving stable nucleos(t)ide analogue (NA) therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Aged 18-55 years;

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.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 500IU/ml .

Disqualifiers

1. Cirrhosis;

2.platelet count < 90×10^9/L, WBC count < 3.0×10^9/L, ALT /AST> ULN (40U/L), total bilirubin > 2ULN;

3.History of or suspicion of hepatocellular carcinoma

4.Patients received interferon therapy within 6 months;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sintilimab

    Drug

    Sintilimab will be administered intravenously at a dose of 1.0 mg/kg at Weeks 0, 6, 12, and 18, for a total of four doses.

  • Pegylated Interferon-α 2b

    Drug

    Peg-IFNα will be administered subcutaneously once weekly from Week 12 through Week 48. Dose: 135 μg or 180 μg, according to the study protocol. When sintilimab and Peg-IFNα are scheduled during the same treatment period, administration of the two drugs will be separated by at least 72 hours.

  • Nucleos(t)ide Analogues

    Drug

    Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.

  • Pegylated Interferon-α 2b

    Drug

    Peg-IFNα will be administered subcutaneously once weekly from Week 0 through Week 48. Dose: 135 μg or 180 μg, according to the study protocol.

  • Nucleos(t)ide Analogues

    Drug

    Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Sequential PD-1 Antibody and Peg-IFNαExperimental treatment 3 interventions
Group B: Peg-IFNαActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

The rate of patients with HBsAg loss at Weeks 24 and 48

Time frame
48weeks
2

Incidence of treatment-emergent adverse events/serious adverse events

Time frame
48weeks

Secondary outcomes

1

The rate of patients with HBsAg decline > 1log(IU/ml) at Weeks 24 and 48

Time frame
48 weeks
2

The rate of patients with HBsAb positive at Weeks 24 and 48.

Time frame
48 weeks
3

The concentration of HBcrAg at baseline, at weeks 12, 24 and 48.

Evaluate the level of serum HBcrAg at baseline, at weeks 12,24 and 48.

Time frame
48 weeks
4

The concentration of pgRNA at baseline, at weeks 12,24 and 48.

Evaluate the level of serum pgRNA at baseline, at weeks 12,24 and 48.

Time frame
48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing 302 Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: