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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Qin Ning, MD., Ph.D.
- Telefoonnummer: +86 278366 2391
- E-mail: qning@vip.sina.com
Studie Contact Back-up
- Naam: Di Wu, MD., Ph.D.
- Telefoonnummer: +86 278366 2391
- E-mail: woody_1984@163.com
Studie Locaties
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Hangzhou, China
- Werving
- Shulan(Hangzhou) hospitai
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Contact:
- Zhe Yu
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Hoofdonderzoeker:
- Zhe Yu
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Nanchang, China
- Werving
- First Affiliated Hospital of Nanchang University
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Contact:
- Xiaoping Wu, Doctor
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Shanghai, China
- Werving
- Shanghai public health clinic
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Contact:
- Liang Chen
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Hoofdonderzoeker:
- Liang Chen
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Wuhan, China
- Nog niet aan het werven
- General Hospital of The Yangtze River Shipping
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Contact:
- Lvye Xu
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Hoofdonderzoeker:
- Lvye Xu
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Wuhan, China
- Werving
- The Seventh Hospital of Wuhan
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Contact:
- Youqin Yan
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Hoofdonderzoeker:
- Youqin Yan
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Xiangya, China
- Werving
- Xiangya Hospital of Central South University
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Hoofdonderzoeker:
- Yan Huang
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Hubei
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Wuhan, Hubei, China, 430030
- Nog niet aan het werven
- Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Contact:
- Qin Ning, Prof.
- Telefoonnummer: 862883662391
- E-mail: qning@vip.sina.com
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Hoofdonderzoeker:
- Qin Ning, Doctor
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Hoofdonderzoeker:
- Di Wu, Doctor
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
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.
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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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
proportion of participants with HBV DNA < 20 IU/mL
Tijdsspanne: 36 months
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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
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36 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
The proportion of patients with HBV DNA < 20 IU/mL
Tijdsspanne: 12 months
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The proportion of patients with HBV DNA < 20 IU/mL at 12 months
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12 months
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The proportion of patients with HBV DNA <300 copies/mL
Tijdsspanne: 12 months
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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
Tijdsspanne: 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
Tijdsspanne: 24 months
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The proportion of patients with HBV DNA <300 copies/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
Tijdsspanne: 36 months
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The proportion of patients with HBV DNA <300 copies/mL at 36 months
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36 months
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Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 36 months
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Proportion of participants with Normal Alanine Aminotransferase (ALT) at 36 months
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36 months
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Change from baseline in fibrosis as assessed by Fibroscan®
Tijdsspanne: 36 months
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Change from baseline in fibrosis as assessed by Fibroscan® at 36 months
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36 months
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Percent Change from baseline in Bone Mineral Density (BMD)
Tijdsspanne: 36 months
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Percent Change from baseline in Bone Mineral Density (BMD) at 36 months
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36 months
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Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)
Tijdsspanne: 36 months
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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
Tijdsspanne: 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
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Qin Ning, MD., Ph.D., Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Lever Ziekten
- Hepatitis, viraal, menselijk
- Hepadnaviridae-infecties
- DNA-virusinfecties
- Hepatitis B
- Hepatitis
- Hepatitis B, chronisch
- Hepatitis, chronisch
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Reverse Transcriptase-remmers
- Nucleïnezuursyntheseremmers
- Enzymremmers
- Anti-hiv-middelen
- Antiretrovirale middelen
- Tenofovir
Andere studie-ID-nummers
- IN-US-320-4669
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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Klinische onderzoeken op Tenofovir Alafenamide
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Gilead SciencesVoltooidChronische hepatitis BFrankrijk, Duitsland, Verenigde Staten, Spanje
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Centre for the AIDS Programme of Research in South...United States Agency for International Development (USAID); FHI 360; CONRADVoltooidHIV-infectiesZuid-Afrika
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Merck Sharp & Dohme LLCVoltooid
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Korea UniversityGilead SciencesVoltooidChronische hepatitis BKorea, republiek van
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National Institute of Diabetes and Digestive and...University of Pittsburgh; National Center for Research Resources (NCRR)VoltooidHepatitis BVerenigde Staten, Canada
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Cytheris SAOnbekend