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

NCT06323681 | Recruiting

• 1 other identifier: Leading Study
• Study Type: interventional
• Target: 2,016
• Locations: 1 country
• Sites: 1

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

Keywords

CHB, peginterferon, functional cure, retreatment

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with HBsAg below the lower limit of detection.

  Week 48

Secondary Outcomes (7)

• Decrease of HBV DNA levels at week 48 compared to baseline.

  Week 48

• Proportion of patients with HBV DNA below the lower limit of detection.

  Week 48

• Decrease of HBsAg levels at week 48 compared to baseline.

  Week 48

• Proportion of patients with HBsAg seroconversion.

  Week 48

• Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive.

  Week 48

Study Arms (2)

Peginterferon α-2b based treatment group

EXPERIMENTAL

Drug: Peginterferon α-2b based treatment group

NAs monotherapy group

ACTIVE COMPARATOR

Drug: NAs monotherapy group

Interventions

Peginterferon α-2b based treatment group 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.

Peginterferon α-2b based treatment group

NAs monotherapy group 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.

NAs monotherapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qing XIe: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of Infectious Disease, Rui Jin

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: February 4, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

CN (1)