- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06323681
Pegylated Interferon α in Previously Interferon-treated CHB(Leading Study)
A Prospective, Multicenter, Non-randomized, Controlled Study to Pursuit Clinical Functional Cure of Pegylated Interferon α in Previously Interferon-treated Chronic Hepatitis B (Leading Study)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Recruiting
- Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
-
Contact:
- Honglian Gui, MD,PhD
- Phone Number: 680419 0086-021-64370045
- Email: lillian_ghl@163.com
-
Contact:
- Qing Xie, MD, PhD.
- Phone Number: 680403 0086-021-64370045
- Email: xieqingrjh@163.com
-
Principal Investigator:
- Qing Xie, MD, PhD.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with HBsAg below the lower limit of detection.
Time Frame: Week 48
|
Week 48
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease of HBV DNA levels at week 48 compared to baseline.
Time Frame: Week 48
|
Week 48
|
Proportion of patients with HBV DNA below the lower limit of detection.
Time Frame: Week 48
|
Week 48
|
Decrease of HBsAg levels at week 48 compared to baseline.
Time Frame: Week 48
|
Week 48
|
Proportion of patients with HBsAg seroconversion.
Time Frame: Week 48
|
Week 48
|
Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive.
Time Frame: Week 48
|
Week 48
|
Proportion of patients with HBeAg seroconversion for patients with baseline HBeAg positive.
Time Frame: Week 48
|
Week 48
|
Serious adverse events.
Time Frame: from baseline to 48 weeks.
|
from baseline to 48 weeks.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Chronic Disease
- Hepatitis B
- Hepatitis
- Hepatitis B, Chronic
- Hepatitis, Chronic
Other Study ID Numbers
- Leading Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Hepatitis b
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
Tongji HospitalGilead SciencesRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Changhai HospitalCompleted
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownChronic Hepatitis b
-
Zhongshan Hospital Xiamen UniversityUnknownHealthy | Chronic Hepatitis B InfectionChina
-
Brii Biosciences LimitedVir Biotechnology, Inc.Active, not recruitingChronic Hepatitis B Virus InfectionSingapore, Thailand, Australia, China, Korea, Republic of
-
Hannover Medical SchoolGerman Center for Infection ResearchRecruiting
-
National Taiwan University HospitalChiayi Christian Hospital; E-DA Hospital; Taipei City Hospital; Taipei Tzu Chi... and other collaboratorsRecruitingChronic Hepatitis b | Hepatitis B ReactivationTaiwan
Clinical Trials on Peginterferon α-2b based treatment group
-
Merck Sharp & Dohme LLCCompleted
-
Emory UniversityBayerCompleted
-
Northwestern UniversityNational Cancer Institute (NCI)TerminatedLymphomaUnited States
-
Hanyang UniversityRoche Pharma AGUnknownHepatitis B, ChronicKorea, Republic of
-
Amsterdam UMC, location VUmcMerck Sharp & Dohme LLC; Novartis; Uppsala University HospitalTerminatedChronic Myeloid LeukemiaNetherlands, Denmark, Sweden, Finland, Norway
-
Albert Einstein College of MedicineInternational Centre for Diarrhoeal Disease Research, BangladeshCompletedDepressive Symptoms
-
Merck Sharp & Dohme LLCCompleted
-
University of MiamiRecruitingAdult T-cell Leukemia-Lymphoma | ATLLUnited States
-
Lund UniversityCompleted
-
St Vincent's Hospital MelbourneMerck Sharp & Dohme LLCUnknownChronic Hepatitis CAustralia