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Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B

11. august 2019 opdateret af: Chongqing Jiachen Biotechnology Ltd.

Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients

The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Second stage(76-144 weeks):

In this follow-up stage the trial is open designed, and all the subjects completed the first stage study(0-76 weeks)

  1. Subjects with virological response but no serological response/with serological response but no virological response/neither virological nor serological response in the first stage, and be willing to continue the this follow-up study, will be treated by εPA-44 900 μg at week 80,83,86,89,92,95,98,101,104,108,112,116,120,124,128.
  2. Subjects with both virological and serological response, will be followed-up to 144 weeks with no Adefovir Dipivoxil or εPA-44 900 μg treatment.

The definition of response as below:

  1. Virological response: HBV DNA<2.93×10∧3IU/ml at 76 weeks;
  2. Serological response: serological conversion of HBeAg at 76 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

209

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Kina
      • Beijing, Kina
        • 302 Militray Hosptial of China
      • Beijing, Kina
        • Hepatitis Institute of Peking University People's Hospital
      • ChongQing, Kina
        • Southwest Hospital
    • Hubei
      • WuHan, Hubei, Kina
        • Renmin hosptial of Wuhan University
    • Hunan
      • ChangSha, Hunan, Kina
        • Xiangya Hospital Central South University
      • Changsha, Hunan, Kina
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • NanJing, Jiangsu, Kina
        • 81th Hospital of PLA
    • Shanxi
      • XiAn, Shanxi, Kina
        • Tangdu Hospital
    • Zhejiang
      • WenZhou, Zhejiang, Kina
        • The First Affiliated Hospital of Wenzhou Medical University

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:

  1. The subjects completed the first stage study(0-76 weeks) and willing to willing to participate in the trial
  2. Uses effective contraception for subject with child-bearing potential (including females and female partners of males)
  3. Understands and signs ICF approved by EC
  4. Willing to comply with the study procedures and complete the study

Exclusion Criteria:

1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: εPA-44 900μg group-placebo
These subjects from the placebo group of protocol 71006.01 InjectεPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Biologisk: εPA-44
subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Andre navne:
  • Terapeutisk HBV-vaccine
Eksperimentel: εPA-44 900μg group-εPA-44 600μg
These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Biologisk: εPA-44
subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Andre navne:
  • Terapeutisk HBV-vaccine
Eksperimentel: εPA-44 900μg group-εPA-44 900μg
These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Biologisk: εPA-44
subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Andre navne:
  • Terapeutisk HBV-vaccine
Ingen indgriben: Follow-up group-placebo
These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
Ingen indgriben: Follow-up group-εPA-44 600μg
These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
Ingen indgriben: Follow-up group-εPA-44 900μg
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period
Tidsramme: Endpoint (LOCF), up to 144 weeks
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
Endpoint (LOCF), up to 144 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
Tidsramme: week95,108,120,144
week95,108,120,144
The Proportion of Patients With Both Negative HBeAg and HBeAb.
Tidsramme: week95,108,120,144
week95,108,120,144
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
Tidsramme: week95,108,120,144
week95,108,120,144
The Proportion of Patients With Both Negative HBsAg and HBsAb.
Tidsramme: week95,108,120,144
week95,108,120,144
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Tidsramme: week95,108,120,144
week95,108,120,144
Change From Baseline by Visit for Serum HBV DNA
Tidsramme: week95,108,120,144
week95,108,120,144
Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;
Tidsramme: week95,108,120,144
week95,108,120,144
Change From Baseline by Vsit for HBeAg Titer.
Tidsramme: week95,108,120,144
Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values
week95,108,120,144

Samarbejdspartnere og efterforskere

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

Sponsor

Chongqing Jiachen Biotechnology Ltd.

Samarbejdspartnere

Third Military Medical University

Efterforskere

  • Ledende efterforsker: Lai Wei, Ph.D., Hepatitis Institute of Peking University 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

1. september 2010

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

6. august 2016

Først indsendt, der opfyldte QC-kriterier

6. august 2016

Først opslået (Skøn)

10. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. august 2019

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 71006.01-2

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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 εPA-44

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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