- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03752658
TAF Real World Study for Universal Effectiveness (TRUE)
A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Qin Ning, MD., Ph.D.
- Telefonnummer: +86 278366 2391
- E-post: qning@vip.sina.com
Studer Kontakt Backup
- Navn: Di Wu, MD., Ph.D.
- Telefonnummer: +86 278366 2391
- E-post: woody_1984@163.com
Studiesteder
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Hangzhou, Kina
- Rekruttering
- Shulan(Hangzhou) hospitai
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Ta kontakt med:
- Zhe Yu
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Hovedetterforsker:
- Zhe Yu
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Nanchang, Kina
- Rekruttering
- First Affiliated Hospital of Nanchang University
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Ta kontakt med:
- Xiaoping Wu, Doctor
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Shanghai, Kina
- Rekruttering
- Shanghai public health clinic
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Ta kontakt med:
- Liang Chen
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Hovedetterforsker:
- Liang Chen
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Wuhan, Kina
- Har ikke rekruttert ennå
- General Hospital of The Yangtze River Shipping
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Ta kontakt med:
- Lvye Xu
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Hovedetterforsker:
- Lvye Xu
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Wuhan, Kina
- Rekruttering
- The Seventh Hospital of Wuhan
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Ta kontakt med:
- Youqin Yan
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Hovedetterforsker:
- Youqin Yan
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Xiangya, Kina
- Rekruttering
- Xiangya Hospital of Central South University
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Hovedetterforsker:
- Yan Huang
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Hubei
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Wuhan, Hubei, Kina, 430030
- Har ikke rekruttert ennå
- Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Ta kontakt med:
- Qin Ning, Prof.
- Telefonnummer: 862883662391
- E-post: qning@vip.sina.com
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Hovedetterforsker:
- Qin Ning, Doctor
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Hovedetterforsker:
- Di Wu, Doctor
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Males and non-pregnant, non-lactating female patients with HBsAg positive > 6 months above 18 years of age; Documented evidence of chronic HBV infection previously; HBV mono-infected HBeAg positive or negative; NA treatment-naive and treatment-experienced; TAF naive; Agree to participate in the study and sign the patient informed consent.
Subjects coinfected with HCV, hepatitis D virus (HDV), human immunodeficiency virus (HIV) or who have received TAF or who haveChild-Pugh C decompensated liver disease or HCC will be excluded.
Beskrivelse
Inclusion Criteria:
- Must have the ability to understand and sign a written informed consent form, consent must be obtained prior to initiation of study procedures
- Adult males and nonpregnant, nonlactating females
- Documented evidence of chronic HBV infection previously
- TAF naive
Exclusion Criteria:
- Patents who were TAF experienced
- Women who are breastfeeding
- Pregnant females
- Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
- Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an imaging study is required)
- Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, fatty liver disease, cholangitis)
- Current evidence of Child-Pugh Score C decompensated liver disease,or moderate to severe ascites, Grade III-IV hepatic encephalopathy
- Abnormal hematological and biochemical parameters, including:
- Albumin < 2.8 mg/ dL
- International normalized ratio (INR) > 2.3 X ULN (unless stable on anticoagulant regimen)
- Total bilirubin > 3 X ULN
- Patient develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
- Received solid organ or bone marrow transplant, except patients who underwent liver or kidney transplantation
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible.
- Individuals receiving ongoing therapy with drugs not to be used with TAF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
- Use of investigational agents within 3 months of screening, unless allowed by the sponsor
- Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening
- Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- In addition to the above exclusion criteria, patients who meet any of the contraindications for TAF
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Tenofovir alafenamide (TAF)
Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with anti-HBV agents.
|
The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
proportion of participants with HBV DNA < 20 IU/mL
Tidsramme: 36 months
|
proportion of participants with HBV DNA < 20 IU/mL as measured by the COBAS TaqMan HBV Test (Roche Molecular Diagnostics, Pleasanton, CA, USA), with taken at 36 months
|
36 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The proportion of patients with HBV DNA < 20 IU/mL
Tidsramme: 12 months
|
The proportion of patients with HBV DNA < 20 IU/mL at 12 months
|
12 months
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The proportion of patients with HBV DNA <300 copies/mL
Tidsramme: 12 months
|
The proportion of patients with HBV DNA <300 copies/mL at 12 months
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12 months
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The proportion of patients with HBV DNA < 20 IU/mL
Tidsramme: 24 months
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The proportion of patients with HBV DNA < 20 IU/mL at 24 months
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24 months
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The proportion of patients with HBV DNA <300 copies/mL IU/mL
Tidsramme: 24 months
|
The proportion of patients with HBV DNA <300 copies/mL at 24 months
|
24 months
|
The proportion of patients with HBV DNA <300 copies/mL IU/mL
Tidsramme: 36 months
|
The proportion of patients with HBV DNA <300 copies/mL at 36 months
|
36 months
|
Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss
Tidsramme: 36 months
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Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss at 36 months
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36 months
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Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe)
Tidsramme: 36 months
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Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) at 36 months
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36 months
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Proportion of participants with Normal Alanine Aminotransferase (ALT)
Tidsramme: 36 months
|
Proportion of participants with Normal Alanine Aminotransferase (ALT) at 36 months
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36 months
|
Change from baseline in fibrosis as assessed by Fibroscan®
Tidsramme: 36 months
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Change from baseline in fibrosis as assessed by Fibroscan® at 36 months
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36 months
|
Percent Change from baseline in Bone Mineral Density (BMD)
Tidsramme: 36 months
|
Percent Change from baseline in Bone Mineral Density (BMD) at 36 months
|
36 months
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Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)
Tidsramme: 36 months
|
Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at 36 months
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36 months
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the rate of mother-to-child transmission of HBV
Tidsramme: at postpartum 6 months
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For unplanned pregnant subjects, if not withdrawn, mother-to-child transmission (MTCT) rate
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at postpartum 6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Qin Ning, MD., Ph.D., Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Leversykdommer
- Hepatitt, viral, menneskelig
- Hepadnaviridae-infeksjoner
- DNA-virusinfeksjoner
- Hepatitt B
- Hepatitt
- Hepatitt B, kronisk
- Hepatitt, kronisk
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Revers transkriptasehemmere
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- Tenofovir
Andre studie-ID-numre
- IN-US-320-4669
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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