Pegylated Interferon α in Previously Interferon-treated CHB（Leading Study）

NCT ID: NCT06323681

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2016 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-04
• Study Completion Date: 2027-08-31

Brief Summary

Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver cirrhosis and liver cancer, and its clinical benefit is expected to be higher than that of NAs monotherapy.

This study is aimed to conduct a large-scale, multicenter, prospective study to confirm the benefit of peginterferon-based therapies in these populations. It expected to enroll about 2000 patients with chronic hepatitis B who have received prior interferon therapy and achieved a good response but without function cure, patients receive either interferon-based therapy or NAs monotherapy, according to their wishes and doctors' professional recommendations, with a ratio of 2:1 between the two groups, and all patients treated for 48 weeks. The HBsAg clearance rate before and after treatment, safety, etc. will be analyzed.

Conditions

Chronic Hepatitis b

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peginterferon α-2b based treatment group

Group Type: EXPERIMENTAL

Peginterferon α-2b based treatment group

Intervention Type: DRUG

Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks. If the baseline HBV DNA is higher than the minimum detection limit (using high-sensitivity kit), combined with nucleos(t)ide analogs (NAs) is recommended.

NAs monotherapy group

Group Type: ACTIVE_COMPARATOR

NAs monotherapy group

Intervention Type: DRUG

First-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), one tablet a day, take orally, for 48 weeks.

Interventions

Peginterferon α-2b based treatment group

Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks. If the baseline HBV DNA is higher than the minimum detection limit (using high-sensitivity kit), combined with nucleos(t)ide analogs (NAs) is recommended.

Intervention Type: DRUG

NAs monotherapy group

First-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), one tablet a day, take orally, for 48 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Understand and sign the informed consent, participate in the study voluntarily.
• Aged between 18 and 65 (including 18 and 65).
• HBsAg positive for at least 6 months or other evidence suggests chronic hepatitis B.
• Had previously received interferon therapy, and discontinuation for at least 6 months at the time of enrollment, with a HBsAg level declined for at least 80% at the end of interferon treatment compared to the level of treatment started.
• HBsAg≤500 IU/mL at screening, and HBsAg rebound should not exceed 50% when compared to the HBsAg level of previously interferon treatment started.
• The pregnancy test within 24 hours previous to the first medication must be negative for women of childbearing. And all participants (male and female) should use effective contraception during the study period.

Exclusion Criteria

• Pregnant or lactating women, or those who had a birth plan during the study period.
• Patients with neuropsychiatric disorders, especially depression, anxiety, mania, schizophrenia and other mental illness history or family history of mental illness.
• Patients with chronic liver disease caused by hepatitis A, hepatitis C, hepatitis E and/or HIV infection, or other causes (such as alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease, etc.).
• Evidence of acute severe liver damage: ALT>10 ULN, or markedly elevated ALT with significantly elevated bilirubin.
• Evidence of uncompensated liver disease: ascites, esophageal and gastric varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc. Or previous evidence of decompensation of cirrhosis.
• Patients with evidence of hepatocellular carcinoma or AFP>1 ULN.
• Kidney diseases: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc. Or serum creatinine >1 ULN at screening.
• Neutrophil count <1.5×10^9/L, platelet count <90×10^9/L, blood phosphorus < 0.8 mmol /L.
• Autoimmune diseases (such as psoriasis, systemic erythematosus, etc.), endocrine system diseases (such as thyroid diseases, diabetes, etc.), hypertension (blood pressure ≥140/90 mmHg) poorly controlled by prescription drugs, serious history of heart disease (especially in the past 6 months), severe retinopathy or other serious eye diseases. Patients with organic disease or dysfunction of other vital organs.
• Patients who plan to receive organ transplant or have already undergone organ transplant.
• Patients who allergic to the investigational drug or any of its excipients, or who meet any contraindication declared in the instructions of the investigational drug.
• Other conditions that are considered inappropriate for enrollment by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qing XIe

OTHER

Sponsor Role: lead

Responsible Party

Qing XIe

Director of Department of Infectious Disease, Rui Jin

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qing Xie, MD, PhD.

Role: primary

xieqingrjh@163.com

0086-021-64370045 ext. 680403

Honglian Gui, MD,PhD

Role: backup

lillian_ghl@163.com

0086-021-64370045 ext. 680419

Other Identifiers

Leading Study

Identifier Type: -

Identifier Source: org_study_id