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Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients

ConditionChronic Hepatitis B
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing 302 Hospital

About this trial

This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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. 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.

Disqualifiers

1. Cirrhosis;

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Sintilimab

    Drug

    100mg/10ml/1bottle

  • NAs

    Drug

    tablets

  • Peg-IFNα-2b

    Drug

    180ug/0.5ml/1bottle

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: PD-1 antibody therapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

The rate of HBsAg loss (<0.05 IU/ml) at 24 weeks and 48 weeks

Evaluate the level of HBsAg (IU/ml) at 24 weeks and 48 weeks.

Time frame
48 weeks
2

Incidence of treatment-emergent adverse events/serious adverse events

Evaluate the treatment-emergent adverse events/serious adverse events

Time frame
48 weeks

Secondary outcomes

1

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

Evaluate the level of serum HBsAg (IU/ml) at 24 weeks and 48 weeks.

Time frame
48 weeks
2

The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.

The rate of HBsAb positive (\>10 IU/ml) at 24 weeks and 48 weeks.

Time frame
48 weeks
3

The concentration of HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks

Evaluate the level of serum HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks.

Time frame
48 weeks
4

The concentration of pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks

Evaluate the level of serum pgRNA (\>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks

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
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