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Study on Clinical Program Optimization of Inactive Hepatitis B Surface Antigen (HBsAg) Carriers (IHCs)

13. juli 2022 opdateret af: Henan Provincial People's Hospital

The Efficacy and Safety of IHCs Treated With Pegylated Interferon α2b Based on Pulse Theray or Sequential Therapy

A multicenter, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control phase (i.e. HBsAg positive, HBeAg negative, normal ALT and HBsAg≤1000IU/ml, HBV DNA≤2000IU/ml) to enter this study, and to compare the feasibility, effectiveness and safety treated with Pegylated Interferon α2b Continuous therapy or Pulse therapy in immune-controlled chronic hepatitis B patients.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients:chronic hepatitis B in the immune control phase (i.e. HBsAg positive, HBeAg negative, normal ALT and HBsAg≤1000IU/ml, HBV DNA≤2000IU/ml). The study patients were divided into two groups.Group A (PEG IFN α- 2b continuous group): PEG IFN was injected subcutaneously once a week from the first day of baseline α- 2b 180 μg. The total course of treatment should not exceed 96 weeks.Group B (PEG IFN α- 2b pulse group): from the first day of baseline, PEG IFN was injected subcutaneously α- 2b 180 μg. Every 8 weeks of injection, stop for 4 weeks, and conduct it periodically.Two groups at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72weeks, 84 weeks, 96 weeks and the 12th and 24th weeks after drug withdrawal, and corresponding examinations were carried out at each follow-up.Check and record adverse events and concomitant medication in detail, and evaluate the compliance of subjects; Blood samples were retained and transported to the laboratory for HBV at baseline, 24 weeks, 48weeks, 72, 96, and 12 and 24 after drug withdrawal.DNA quantification and detection of hepatitis B virus markers.The efficacy and safety were evaluated after the study.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Henan
      • Zhengzhou, Henan, Kina, 450000
        • Rekruttering
        • Henan Provincial People's Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • age 18 to 65 years, both male and female (including 18 and 65 years old);
  • HBV DNA≤2000 IU/ml and HBeAg negative;
  • HBsAg positive for more than 6 months, and HBsAg≤1000 IU/ml;
  • ALT≤ULN at screening (discontinue liver-protecting enzyme-lowering drugs for at least 2 weeks);
  • A negative urine or serum pregnancy test (for women of childbearing age) within 24 hours before the first dose;
  • B-ultrasound or fibroscan suggest no liver cirrhosis;
  • Willing to accept treatment and sign informed consent.

Exclusion Criteria:

  • Participants with other hepatotropic viruses or human immunodeficiency virus co-infection;
  • other chronic non-viral liver diseases or decompensated liver diseases;
  • tumours;
  • drug abuse;
  • severe psychiatric disease;
  • uncontrolled thyroid disease or diabetes;
  • pregnancy or lactation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A (continuous treatment group)
The treatment period is 12 weeks as a treatment unit, starting from the first day of baseline, subcutaneous injection of Peg-IFNα-2b 180μg once a week, the total treatment course does not exceed 96 weeks. During treatment, when any efficacy check point reaches the disappearance of HBsAg with or without the appearance of HBsAb, at least 2 treatment units of consolidation therapy are given and then the drug is discontinued. Observed for 24 weeks after treatment.
Adfærdsmæssigt: continuous treatment
The treatment period is 12 weeks as a treatment unit, starting from the first day of baseline, subcutaneous injection of Peg-IFN α-2b 180μg once a week, or every 8 weeks of injection, 4 weeks off, periodically, the total treatment course does not exceed 96 weeks.
Eksperimentel: Group B (pulse therapy group)
The treatment period is 12 weeks as a treatment unit. From the first day of baseline, subcutaneous injection of Peg-IFNα-2b 180 μg, every injection for 8 weeks, stop for 4 weeks, periodically, the total treatment course does not exceed 96 weeks. During treatment, when any efficacy check point reaches the disappearance of HBsAg with or without the appearance of HBsAb, at least 2 treatment units of consolidation therapy are given and then the drug is discontinued. Observed for 24 weeks after treatment.
Adfærdsmæssigt: pulse therapy
pulse therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Extent of HBsAg decrease at 48 weeks
Tidsramme: 48 weeks
Decreasing level and difference of HBsAg in different treatment groups after 48 week treatment
48 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HBsAg clearance at the end of 96 weeks of treatment
Tidsramme: 96 weeks
To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 96 week treatment
96 weeks
The decreasing extent of HBsAg level at 96 weeks
Tidsramme: 96 weeks
Decreasing level and difference of HBsAg in different treatment groups after 96 week treatment
96 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Henan Provincial People's Hospital

Efterforskere

  • Studiestol: Jia Shang, Henan Provincial People's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2021

Primær færdiggørelse (Forventet)

31. oktober 2023

Studieafslutning (Forventet)

30. september 2024

Datoer for studieregistrering

Først indsendt

11. juli 2022

Først indsendt, der opfyldte QC-kriterier

13. juli 2022

Først opslået (Faktiske)

14. juli 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HenanPPHGRS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

After publication

IPD-delingstidsramme

End of study

IPD-delingsadgangskriterier

Editors and reviewers of contributing magazines

IPD-deling Understøttende informationstype

  • Studieprotokol

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kronisk hepatitis B

Kliniske forsøg med continuous treatment

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