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Enrolling by Invitation

NCT Number: NCT06707922

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Youan Hospital, Capital Medical University, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. The incidence of Hepatocellular Carcinoma(HCC).

    Time frame: 5 years after the completion of the TB1901IFN study.

  2. The incidence all-cause mortality.

    Time frame: 5 years after the completion of the TB1901IFN study.

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

    Time frame: 5 years after the completion of the TB1901IFN study.

    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

  4. 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.

    Time frame: After completing the 72-week combined re-treatment.

Sponsors and collaborators

Lead sponsor

Xiamen Amoytop Biotech Co., Ltd.

Industry

Collaborators

  • Peking University First Hospital

Registry information

Official study title

A Multicenter, Prospective, Follow-up Study to Evaluate the Long-term Benefits of Peginterferon Alpha-2b Injection Combined With TDF in Patients With Chronic Hepatitis B

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Nov 27, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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