Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

TAF in Early/Middle Pregnancy With CHB (TAF;CHB)

21. juni 2026 opdateret af: The Third Affiliated Hospital of Guangzhou Medical University

Efficacy and Safety of TAF Used in Early and Middle Pregnancy With Chronic Hepatitis B: a Multicenter Prospective Cohort Study

The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B. Previous studies have found that TAF has good clinical efficacy in the treatment of antiviral therapy in patients with chronic hepatitis B. In order to evaluate the clinical efficacy of TAF after antiviral therapy in pregnant women with chronic hepatitis B in the first and second trimesters, the clinical efficacy of TAF after antiviral therapy was evaluated by comparing the safety (including changes in maternal ALT, bilirubin, creatinine, blood phosphorus, blood lipids, fetal malformation rate, neonatal birth defects, head circumference, height, weight, intelligence and other indicators) and effectiveness (viral load decrease, serological conversion, mother-to-fetal blockade, etc.) with the TDF group.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

816

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • The Third Affiliated Hospital of Guangzhou 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

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Between the ages of 20 and 40
  • HBsAg positive for >= 6 months
  • 0-24 week of pregnancy
  • Meets the indications for antiviral therapy in the 2022 version of the guidelines for the prevention and treatment of chronic hepatitis B
  • It is planned to use TAF or TDF antiviral therapy until the end of delivery or long-term administration, and follow-up will be carried out in this research institution
  • Signed informed consent for medication

Exclusion Criteria:

  • Previous use of anti-hepatitis B virus drugs (e.g., entecavir, tenofovir, tenofovir alafenol, emintenofovir, adefovir dipoproxil, telbivudine, etc.)
  • Concomitant viral hepatitis A, C, E or other hepatotropic virus infection or AIDS
  • Concomitant cirrhosis, liver cancer or other chronic liver diseases (e.g., alcoholic liver, autoimmune liver disease, G6PD deficiency, etc.)
  • Patients with heart (such as coronary heart disease, myocardial infarction, heart failure, etc.), lung (such as: lung cancer, chronic obstructive pulmonary disease, tuberculosis, etc.), kidney (such as: renal failure, elevated creatinine, nephritis, nephrotic syndrome, etc.) and other important organ diseases
  • Chronic diseases such as autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, anticoagulant antibody syndrome), hypertension, diabetes, thyroid disease, etc
  • Patients with previous pregnancy complications (such as: gestational hypertension, gestational diabetes, gestational eclampsia, etc.)
  • Those who have had fetal or neonatal growth and development defects in previous pregnancies
  • Previous or ongoing use of nephrotoxic medications, glucocorticoids, nonsteroidal anti-inflammatory drugs, cytotoxic drugs, or immunomodulators
  • Premedication ultrasound showed fetal malformations, fetal development abnormalities, placental abnormalities, threatened abortion, etc

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: tenofovir alafenamide
An oral drug for reducing hepatitis B virus levels.
Medicin: TAF
Taking TAF from early or middle pregnancy
Andre navne:
  • tenofoviralafenamid
Aktiv komparator: tenofovir disoproxil fumarate
An oral drug for reducing hepatitis B virus levels.
Medicin: TDF
Taking TDF from early or middle pregnancy
Andre navne:
  • tenofovirdisoproxilfumarat

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess the incidence of ALT above normal (>=1 time) of mother
Tidsramme: not more than 48 weeks
From the time of initiation of antiviral and normal ALT until delivery
not more than 48 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess the level of HBV-DNA of baby
Tidsramme: not more than 7 months
At birth; At 7 months of age
not more than 7 months
To assess the level of HBV-DNA of mother
Tidsramme: not more than 48 weeks
Every 4 weeks of pregnancy
not more than 48 weeks
To assess the results of liver Ultrasound of mother
Tidsramme: not more than 48 weeks
At the time of enrollment; During childbirth
not more than 48 weeks
To assess the weight in kilograms of baby
Tidsramme: not more than 7 months
At birth; At 7 months of age
not more than 7 months
To assess the height in meters of baby
Tidsramme: not more than 7 months
At birth; At 7 months of age
not more than 7 months
The number of HBsAg positive of baby
Tidsramme: not more than 7 months
At birth; At 7 months of age
not more than 7 months
The number of HBeAg positive of baby
Tidsramme: not more than 7 months
At birth; At 7 months of age
not more than 7 months
The number of HBsAg positive of mother
Tidsramme: not more than 48 weeks
Every 4 weeks of pregnancy
not more than 48 weeks
The number of HBeAg positive of mother
Tidsramme: not more than 48 weeks
Every 4 weeks of pregnancy
not more than 48 weeks
The rate of deformity
Tidsramme: not more than 48 weeks
Fetal period
not more than 48 weeks
The rate of Birth defect
Tidsramme: 1 day
At birth
1 day
The levels of creatinine of mother
Tidsramme: not more than 48 weeks
From the time of initiation of antiviral until delivery
not more than 48 weeks
The levels of blood lipids of mother
Tidsramme: not more than 48 weeks
From the time of initiation of antiviral until delivery
not more than 48 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Samarbejdspartnere

Second Affiliated Hospital of Guangzhou Medical University
Qingyuan People's Hospital

Efterforskere

  • Ledende efterforsker: Panpan Zhai, The Third Affiliated Hospital of Guangzhou Medical University

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)

31. marts 2025

Primær færdiggørelse (Anslået)

30. marts 2027

Studieafslutning (Anslået)

30. marts 2028

Datoer for studieregistrering

Først indsendt

9. april 2026

Først indsendt, der opfyldte QC-kriterier

21. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • [2025]004

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 TAF

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Tanzania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner