- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Qin Ning, MD., Ph.D.
- Telefonnummer: +86 278366 2391
- E-Mail: qning@vip.sina.com
Studieren Sie die Kontaktsicherung
- Name: Di Wu, MD., Ph.D.
- Telefonnummer: +86 278366 2391
- E-Mail: woody_1984@163.com
Studienorte
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Hangzhou, China
- Rekrutierung
- Shulan(Hangzhou) hospitai
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Kontakt:
- Zhe Yu
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Hauptermittler:
- Zhe Yu
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Nanchang, China
- Rekrutierung
- First Affiliated Hospital of Nanchang University
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Kontakt:
- Xiaoping Wu, Doctor
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Shanghai, China
- Rekrutierung
- Shanghai public health clinic
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Kontakt:
- Liang Chen
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Hauptermittler:
- Liang Chen
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Wuhan, China
- Noch keine Rekrutierung
- General Hospital of The Yangtze River Shipping
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Kontakt:
- Lvye Xu
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Hauptermittler:
- Lvye Xu
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Wuhan, China
- Rekrutierung
- The Seventh Hospital of Wuhan
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Kontakt:
- Youqin Yan
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Hauptermittler:
- Youqin Yan
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Xiangya, China
- Rekrutierung
- Xiangya Hospital of Central South University
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Hauptermittler:
- Yan Huang
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Hubei
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Wuhan, Hubei, China, 430030
- Noch keine Rekrutierung
- Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Kontakt:
- Qin Ning, Prof.
- Telefonnummer: 862883662391
- E-Mail: qning@vip.sina.com
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Hauptermittler:
- Qin Ning, Doctor
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Hauptermittler:
- Di Wu, Doctor
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
proportion of participants with HBV DNA < 20 IU/mL
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The proportion of patients with HBV DNA < 20 IU/mL
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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®
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Qin Ning, MD., Ph.D., Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Leberkrankheiten
- Hepatitis, viral, menschlich
- Hepadnaviridae-Infektionen
- DNA-Virusinfektionen
- Hepatitis B
- Hepatitis
- Hepatitis B, chronisch
- Hepatitis, chronisch
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Reverse-Transkriptase-Inhibitoren
- Inhibitoren der Nukleinsäuresynthese
- Enzym-Inhibitoren
- Anti-HIV-Agenten
- Antiretrovirale Mittel
- Tenofovir
Andere Studien-ID-Nummern
- IN-US-320-4669
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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