A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B

March 4, 2024 updated by: Xiamen Amoytop Biotech Co., Ltd.

A Multi-center, Randomized, Blinded Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b Injection Combined With Tenofovir Disoproxil Fumarate Tablets in Patients With Chronic Hepatitis B

Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. This study is aimed to exploit the safety and efficacy of the study drug, Peginterferon alfa-2b injection, with nucleos(t)ide (NAs), tenofovir disoproxil fumarate tablets (TDF), in the patients with hepatitis B, who has previously treated with nucleos(t)ides and who are treatment naïve.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
475

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital
      • Beijing, China
        • The Fifth Medical Center of PLA General Hospital
      • Beijing, China
        • Beijing Ditan Hospital, Capital Medical University
      • Beijing, China
        • Beijing Youan Hospital, Capital Medical University
      • Changsha, China
        • Xiangya Hospital Central South University
      • Changsha, China
        • The Second Xiangya Hospital of Central South University
      • Chengdu, China
        • Public Health Clinical Center of Chengdu
      • Chengdu, China
        • Sichuan Provincial People's Hospital
      • Fuzhou, China
        • Mengchao Hepatobiliary Hosipital of Fujian Medical University
      • Fuzhou, China
        • The First Affiliated Hospital of Fujian Medical University
      • Fuzhou, China
        • The Ninth Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army
      • Guangzhou, China
        • Guangzhou Eighth People's Hospital
      • Guangzhou, China
        • the Third Affiliated Hospital,Sun Yat-Sen University
      • Harbin, China
        • The Fourth Affiliated Hospital of Harbin Medical University
      • Hefei, China
        • The First Affiliated Hospital of Anhui Medical University
      • Nanjing, China
        • Nanjing Drum Tower Hospital/The First Affiliated Hospital of Nanjing University Medical School
      • Shanghai, China
        • Huashan Hospital Affiliated to Fudan University
      • Shanghai, China
        • Ruijin Hospital, Shanghai JiaoTong University School of Medicine
      • Shenyang, China
        • The Sixth People's Hospital of Shenyang
      • Shenzhen, China
        • Peiking University Shenzhen Hospital
      • Shenzhen, China
        • The Third People's Hospital of Shenzhen
      • Taiyuan, China
        • The First Hospital of Shanxi Medical University
      • Tianjin, China
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
      • Tianjin, China
        • Tianjin Third Central Hospital
      • Urumqi, China
        • The First Affiliated Hospital of Xinjiang Medical University
      • Urumqi, China
        • Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
      • Wuhan, China
        • Tongji Hospital/Tongji Medical College Huazhong University of Science & Technology
      • Xi'an, China
        • Tangdu Hospital
      • Xi'an, China
        • The First Affiliated Hospital of Xian Jiaotong University
      • Xiamen, China
        • The First Affiliated Hospital of Xiamen University
      • Xiamen, China
        • Xiamen Hospital of Traditional Chinese Medicine
      • Yanbian, China
        • Yanbian University Hospital/Yanbian Hospital
      • Zhengzhou, China
        • Henan Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Understand and sign the informed consent form voluntarily.
  • Age between 18 and 65 years (including 18 and 65), no gender limit.
  • HBsAg-positive for at least 6 months or other evidence supporting chronic infection with hepatitis B virus.
  • HBsAg positive at screening.
  • For NAs treated patients: Who should have continuously taken NAs for at least 9 months prior to screening, and are currently receiving the NAs. Simultaneously, the patients should have achieved the following criteria: HBsAg<1500IU/mL, HBV DNA<100IU/ml, HBeAg<10s/co at screening.
  • For treatment naive patients: HBV DNA≥1×10^4IU/ml, and 2×ULN (upper limit of normal) ≤ALT≤10×ULN at screening.
  • Pregnancy test of female of childbearing must be negative within 24 hours before the first medication, and the subjects (male and female) should take effective contraceptive measures during the whole study period.

Exclusion Criteria:

  • Women who are pregnant, breastfeeding or planning to pregnant during the study period.
  • Subjects with neuropsychiatric diseases and/or neuropsychiatric family history, especially depression, anxiety, or mania schizophrenia.
  • Co-infected with Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E, or HIV.
  • Chronic hepatitis other than hepatitis B, e.g. alcoholic hepatitis, drugs-induced hepatitis, or autoimmune hepatitis, etc.
  • Moderate to severe steatohepatitis.
  • Evidence of acute severe hepatitis, e.g. ALT>10×ULN, significantly increasing in ALT accompanied by elevated bilirubin, etc.
  • Evidence of liver decompensation, e.g. total bilirubin higher than 2×ULN, albumin lower than 35g/L, prothrombin time is 3 seconds longer than the upper limit of normal, prothrombin activity lower than 60%, or history of decompensated liver cirrhosis, etc.
  • Evidence of hepatocellular carcinoma, or AFP>1×ULN.
  • Significant kidney diseases, including acute nephritis, chronic nephritis, renal insufficiency, nephrotic syndrome, etc. or serum creatinine higher than upper limit of normal.
  • Neutrophil count less than 1.5×10^9/L, or platelet count less than 90×10^9/L at screening.
  • Serum phosphorus lower than 0.8mmol/L.
  • Antinuclear antibody (ANA) exceeds 1:100.
  • Autoimmune disease, including psoriasis, systemic lupus erythematosus, etc.
  • Subjects with endocrine system disease, including thyroid, Diabetes mellitus, etc.
  • Poorly controlled hypertension (blood pressure ≥140/90 mmHg).
  • Subjects with severe heart disease, especially those with unstable angina or poorly controlled heart disease within 6 months prior to screening.
  • Severe retinopathy or any other severe diseases in the eyes.
  • Subject who had ever received organ transplants or are planning to receive organ transplant.
  • For NAs-treated patients: who have received standard treatment of interferon products within 6 months prior to screening .
  • For treatment naive patients: who have ever received standard treatment of interferon products, or who have ever received NAs within 6 months prior to screening.
  • Subject who are allergic to interferon, tenofovir, or any excipients, or meet any of the contraindications described in the drug instructions.
  • Subjects who participated in any other interventional trials within 3 months prior to screening, or with any other conditions which in the opinion of the investigator precluding enrollment from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nucleot(s)ide-treated patients-Experimental Group 1
Drug: Peginterferon alfa-2b injection
Peginterferon alfa-2b injection (high dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
Drug: Peginterferon alfa-2b injection
Peginterferon alfa-2b injection (low dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
Drug: Peginterferon alfa-2b injection
Peginterferon alfa-2b injection will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
Experimental: Nucleot(s)ide-treated patients-Experimental Group 2
Drug: Peginterferon alfa-2b injection
Peginterferon alfa-2b injection (high dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
Drug: Peginterferon alfa-2b injection
Peginterferon alfa-2b injection (low dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
Drug: Peginterferon alfa-2b injection
Peginterferon alfa-2b injection will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
Active Comparator: Nucleot(s)ide-treated patients-Control Group
Drug: TDF
Patients will take TDF orally for the first 48 weeks, and then one can choose to continue the single-TDF treatment up to 144 weeks, or may choose to change to receive peginterferon alfa-2b combined TDF therapy for the later 96 weeks, peginterferon alfa-2b will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 weeks a cycle. And then followed for 24 weeks after treatment.
Other: Treatment Naive Group
Drug: Peginterferon alfa-2b injection
Peginterferon alfa-2b injection (high dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
Drug: Peginterferon alfa-2b injection
Peginterferon alfa-2b injection (low dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
Drug: Peginterferon alfa-2b injection
Peginterferon alfa-2b injection will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of patients with HBsAg negative.
Time Frame: 24 weeks post treatment.
24 weeks post treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes of HBsAg level from baseline.
Time Frame: up to 168 weeks.
up to 168 weeks.
Proportion of patients with HBsAg seroconversion.
Time Frame: up to 168 weeks.
up to 168 weeks.
Proportion of patients with HBeAg negative.
Time Frame: up to 168 weeks
up to 168 weeks
Proportion of patients with HBeAg seroconversion.
Time Frame: up to 168 weeks.
up to 168 weeks.
Changes of HBeAg level from baseline.
Time Frame: up to 168 weeks.
up to 168 weeks.
Proportion of patients with HBV DNA undetectable.
Time Frame: up to 168 weeks.
up to 168 weeks.
Changes of HBV DNA level from baseline.
Time Frame: up to 168 weeks.
up to 168 weeks.
Proportion of patients with ALT normalization.
Time Frame: up to 168 weeks.
up to 168 weeks.
Proportion of patients with liver fibrosis.
Time Frame: up to 168 weeks.
up to 168 weeks.
Proportion of patients with liver cirrhosis.
Time Frame: up to 168 weeks.
up to 168 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiamen Amoytop Biotech Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University First Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guiqiang Wang, Ph.D, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TB1901IFN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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