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

NCT06707922 | Enrolling By Invitation

• 1 other identifier: TB2111IFN
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 30

Brief Summary

Studies have shown that chronic hepatitis B patients with low levels of HBsAg after nucleos(t)ide analog therapy have a higher chance of functional cure with sequential or combined pegylated interferon therapy, with about 30-50% of patients achieving HBsAg clearance and discontinuing therapy. There are some clinical practices on the long-term benefits of discontinuing antiviral therapy, but there is a lack of evidence-based clinical studies, especially on the relapse rate, duration of relapse, and factors influencing relapse after achieving functional cure. Furthermore, there is no guideline or expert consensus on the follow-up management strategy for patients who haven't achieved functional cure but whose HBsAg levels have been substantially reduced by treatment and are at low levels. Therefore, this study is planned to enroll participants who have completed the TB1901IFN to evaluate the long-term benefit of Peginterferon in combination with tenofovir disoproxil fumarate（TDF） and relapse in patients who have achieved functional cure, for participant with low-level HBsAg at the end of treatment, peginterferon combined with tenofovir alafenamide fumarate （TAF）therapy will be administered to explore the efficacy and safety of starting treatment after a period of drug discontinuation. Participants will be divided into 3 cohorts based on functional achievement and/or HBsAg levels after completion of TB1901IFN

Conditions

Chronic Hepatitis B

Keywords

Peginterferon Alfa; Tenofovir Disoproxil Fumarate; Relapse; Retreatment

Outcome Measures

Primary Outcomes (4)

• The incidence of Hepatocellular Carcinoma(HCC).

  5 years after the completion of the TB1901IFN study.

• The incidence all-cause mortality.

  5 years after the completion of the TB1901IFN study.

• Relapse within 5 years of discontinuation in participants who achieved functional cure.

  Relapse was defined as the occurrence of two consecutive time, interval greater than one month, HBsAg≥0.05 IU/ml at any time during the follow-up period

  5 years after the completion of the TB1901IFN study.

• Rate of functional cure of re-initiation of combination therapy after discontinued for more than 24 weeks in participants who had a favorable outcome on prior therapy and obtained low levels of S antigen.

  After completing the 72-week combined re-treatment.

Study Arms (3)

Cohort 1

NO INTERVENTION

Participants who have achieved functional cure at the time of completion of TB1901IFN will be included and followed up for 5 years without any intervention.

Cohort 2

EXPERIMENTAL

Participants with S antigen decrease≥1log and the S antigen level \<100IU/ml at enrollment, or who with S antigen decrease ≥1.5log and the S antigen level \<1500IU/ml after TB1901IFN treatment, will initially treated with 72-week pulse treatment of peginterferon in combination with TAF, and then followed up to 5 years.

Drug: Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate

Cohort 3

NO INTERVENTION

Except for those who already enrollment in Cohort 2, Participants with functional cure achievement will enroll in Cohort 3, and follow-up for 5 years without any study intervention.

Interventions

Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate DRUG

Peginterferon α-2b Injection, subcutaneous injection, once a week. Tenofovir Alafenamide Fumarate, Oral administration, once a day.

Cohort 2

Eligibility Criteria

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

You may qualify if:

• Participants who completion of the TB1901IFN study ("completion" is defined as completion of more than 80% of trial medications (including peginterferon alfa and tenofovir disoproxil fumarate), or meeting criteria for early discontinuation and completion of consolidation therapy, as well as completion of discontinuation follow-up and 24-week post-discontinuation visit);
• Voluntary enrollment, understand and sign the informed consent form.
• For cohort 1 only; - Subjects who have achieved functional cure (defined as the disappearance of HBsAg at the completion of TB1901IFN, with or without the appearance of HBsAb);
• For cohort 2 only:
• At the completion of TB1901IFN, the S antigen level has decreased by ≥1 log compared to the baseline, with an S antigen level of less than 100 IU/ml, or the S antigen level has decreased by ≥1.5 log compared to the baseline, with an S antigen level of less than 1500 IU/ml;
• Willing to accept the treatment of peginterferon combined with TAF;
• For cohort 3 only:
• \- Participants who have not achieved functional cure upon completion of TB1901IFN (defined as HBsAg ≥ 0.05 IU/ml)；

You may not qualify if:

• \- Suspected or confirmed HCC patients.
• For Cohort 2 only:
• Suspected or confirmed liver cirrhosis.
• Pregnant, breastfeeding women, or those who plan to conceive during the combined medication treatment period.
• Evidence of acute severe liver injury: e.g. ALT \> 10 times of the upper limit of normal (ULN), or a significant increase in ALT accompanied by a significant increase in bilirubin;
• Evidence of decompensated liver disease: serum total bilirubin \> 2ULN, serum albumin \< 35 g/L, prothrombin time extended by more than 3 seconds beyond ULN, prothrombin activity \< 60%; or a history of decompensated liver cirrhosis;
• Kidney disease: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc., or serum creatinine \> 1ULN;
• Neutrophil count \< 1.5×10\^9/L, platelet count \< 90×10\^9/L;
• Severe retinopathy or other severe ophthalmic diseases;
• Other conditions deemed by the investigator to be unsuitable for participation in the cohort 2.
• For cohort 3 only:
• \- Participants who plan to enter Cohort 2.

Sponsors & Collaborators

• Xiamen Amoytop Biotech Co., Ltd.: lead
• Peking University First Hospital: collaborator

Study Sites (30)

Peking University First Hospital

Beijing, 100034, China

Location

Beijing Youan Hospital, Capital Medical University

Beijing, China

Location

The fifth medical center of PLA General Hospital

Beijing, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

Xiangya Hospital Central South University

Changsha, China

Location

Public Health Clinical Center of Chengdu

Chengdu, China

Location

Sichuan Provincial People's Hospital

Chengdu, China

Location

Mengchao Hepatobiliary Hosipital of Fujian Medical University

Fuzhou, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Location

Guangzhou Eighth People's Hospital

Guangzhou, China

Location

The Third Affiliated Hospital,SUN YAT-SEN University

Guanzhou, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Location

Huashan Hospital ,Fudan University

Shanghai, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

The Sixth People's Hospital of Shenyang

Shenyang, China

Location

Peiking University Shenzhen Hospital

Shenzhen, China

Location

The Third People's Hospital of shenzhen

Shenzhen, China

Location

The First Hospital of Shanxi Medical University

Taiyuan, China

Location

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Location

Tianjin Third Central Hospital

Tianjin, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, China

Location

Traditional Chinese Medical hospital of Xinjiang Uygur Autonomous Region

Ürümqi, China

Location

Tongji Hospital,Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Location

Tangdu Hospital,Air Force Medical University

Xi'an, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, China

Location

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, China

Location

Yanbian University Hospital/Yanbian Hospital

Yanji, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Recurrence

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 Officials

• Guiqiang Wang, Ph.D

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: March 18, 2022
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (30)