- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02979613
Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching From Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25 mg QD in Subjects With Chronic Hepatitis B Who Are Virologically Suppressed
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Edmonton, Canada
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Toronto, Canada
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Vancouver, Canada
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Daegu, Corea, Repubblica di, 700-721
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Seoul, Corea, Repubblica di
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Seoul, Corea, Repubblica di, 135-710
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Seoul, Corea, Repubblica di, 05505
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Seoul, Corea, Repubblica di, 03722
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Seoul, Corea, Repubblica di, 152-703
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Seoul, Corea, Repubblica di, 06973
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Seoul, Corea, Repubblica di, 03830
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Gyeonggi-d
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Goyang, Gyeonggi-d, Corea, Repubblica di
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
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Milan, Italia, 20122
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London, Regno Unito
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London, Regno Unito, E1 1BB
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Barcelona, Spagna
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Majadahonda, Spagna
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California
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Los Angeles, California, Stati Uniti
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Palo Alto, California, Stati Uniti
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Pasadena, California, Stati Uniti
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San Diego, California, Stati Uniti
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San Francisco, California, Stati Uniti
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San Jose, California, Stati Uniti
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Maryland
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Baltimore, Maryland, Stati Uniti
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Massachusetts
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Boston, Massachusetts, Stati Uniti
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Michigan
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Novi, Michigan, Stati Uniti
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New York
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Flushing, New York, Stati Uniti
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Flushing, New York, Stati Uniti, 11355
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New York, New York, Stati Uniti
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New York, New York, Stati Uniti, 10029
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti
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Philadelphia, Pennsylvania, Stati Uniti, 19107
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Tennessee
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Nashville, Tennessee, Stati Uniti
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Texas
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Sugar Land, Texas, Stati Uniti, 77478
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Chiayi City, Taiwan, 60002
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Kaohsiung, Taiwan
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Taipei City, Taiwan, 10002
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Key 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 male and non-pregnant, non-lactating females
- Documented evidence of chronic hepatitis B virus (HBV) infection previously
- Maintained on tenofovir disoproxil fumarate (TDF) 300 mg once daily for at least 48 weeks, and as monotherapy for chronic hepatitis B for at least 24 weeks with viral suppression (HBV DNA < lower limit of quantitation) for a minimum of 12 weeks prior to screening
- Adequate renal function
- Normal Electrocardiogram
Key Exclusion Criteria:
- Pregnant women or women who are breastfeeding
- Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study.
- Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or human immunodeficiency virus (HIV)
- Evidence of hepatocellular carcinoma
- Current evidence of, or recent (≤ 5 year) history of clinical hepatic decompensation
Abnormal hematological and biochemical parameters, including:
- Hemoglobin < 10 g/dL
- Absolute neutrophil count < 750/mm^3
- Platelets ≤ 50,000/mm^3
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 × upper limit of the normal (ULN)
- Albumin < 3.0 mg/ dL
- International normalized ratio (INR) > 1.5 × ULN (unless stable on anticoagulant regimen)
- Total bilirubin > 2.5 × ULN
- Received solid organ or bone marrow transplant
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (eg, basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible.
- Currently receiving therapy with immunomodulators (eg, corticosteroids), nephrotoxic agents, or agents capable of modifying renal excretion
- Individuals receiving ongoing therapy with drugs not to be used with TAF or TDF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients
- Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: TAF 25 mg
Double-blind (DB) phase: TAF 25 mg + TDF placebo for up to 53 weeks.
Open-label extension (OLE) phase: TAF 25 mg for up to 52 weeks.
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Compressa da 25 mg somministrata per via orale una volta al giorno
Altri nomi:
Compressa somministrata per via orale una volta al giorno
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Comparatore attivo: TDF 300 mg
DB phase: TDF 300 mg + TAF placebo for up to 50 weeks.
OLE phase: TAF 25 mg for up to 52 weeks.
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Compressa da 25 mg somministrata per via orale una volta al giorno
Altri nomi:
Compressa da 300 mg somministrata per via orale una volta al giorno
Altri nomi:
Compressa somministrata per via orale una volta al giorno
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
Lasso di tempo: Week 48
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The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:
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Week 48
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm
Lasso di tempo: Week 96
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The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:
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Week 96
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Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48
Lasso di tempo: Weeks 48
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The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window.
Missing=Failure (M = F) approach was used for analysis.
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Weeks 48
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Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48
Lasso di tempo: Week 48
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The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window.
The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches.
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Week 48
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Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96
Lasso di tempo: Week 96
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The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window.
M = F approach was used for analysis.
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Week 96
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Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96
Lasso di tempo: Week 96
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The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window.
The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches.
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Week 96
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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48
Lasso di tempo: Week 48
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HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing.
The M = F approach was used for this analysis.
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Week 48
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Percentage of Participants With HBeAg Seroconversion at Week 48
Lasso di tempo: Week 48
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HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit.
The M = F approach was used for this analysis.
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Week 48
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Percentage of Participants With HBeAg Loss at Week 96
Lasso di tempo: Week 96
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HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing.
The M = F approach was used for this analysis.
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Week 96
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Percentage of Participants With HBeAg Seroconversion at Week 96
Lasso di tempo: Week 96
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HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit.
The M = F approach was used for this analysis.
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Week 96
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
Lasso di tempo: Week 48
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HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing.
The M = F approach was used for this analysis.
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Week 48
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Percentage of Participants With HBsAg Seroconversion at Week 48
Lasso di tempo: Week 48
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HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit.
The M = F approach was used for this analysis.
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Week 48
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Percentage of Participants With HBsAg Loss at Week 96
Lasso di tempo: Week 96
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HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing.
The M = F approach was used for this analysis.
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Week 96
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Percentage of Participants With HBsAg Seroconversion at Week 96
Lasso di tempo: Week 96
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HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit.
The M = F approach was used for this analysis.
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Week 96
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Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)
Lasso di tempo: Week 48
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Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years.
The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males.
M = F approach was used for analysis.
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Week 48
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Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)
Lasso di tempo: Week 48
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ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years.
The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males.
M = F approach was used for analysis.
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Week 48
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Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)
Lasso di tempo: Week 96
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Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years.
The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males.
M = F approach was used for analysis.
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Week 96
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Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)
Lasso di tempo: Week 96
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ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years.
The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males.
M = F approach was used for analysis.
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Week 96
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Change From Baseline in FibroTest® Score at Week 48
Lasso di tempo: Baseline; Week 48
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The FibroTest score is used to assess liver fibrosis.
Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
Change from baseline was calculated as the value at Week 48 minus the value at Baseline.
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Baseline; Week 48
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Change From Baseline in FibroTest® Score at Week 96
Lasso di tempo: Baseline; Week 96
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The FibroTest score is used to assess liver fibrosis.
Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
Change from baseline was calculated as the value at Week 96 minus the value at Baseline.
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Baseline; Week 96
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Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Lasso di tempo: Baseline; Week 48
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Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
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Baseline; Week 48
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Percent Change From Baseline in Hip BMD at Week 96
Lasso di tempo: Baseline; Week 96
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Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
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Baseline; Week 96
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Percent Change From Baseline in Spine BMD at Week 48
Lasso di tempo: Baseline; Week 48
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Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
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Baseline; Week 48
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Percent Change From Baseline in Spine BMD at Week 96
Lasso di tempo: Baseline; Week 96
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Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
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Baseline; Week 96
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Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48
Lasso di tempo: Baseline; Week 48
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Cockcroft-Gault formula is as follows:
Change from baseline was calculated as the value at Week 48 minus the value at Baseline. |
Baseline; Week 48
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Change From Baseline in eGFR-CG at Week 96
Lasso di tempo: Baseline; Week 96
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Cockcroft-Gault formula is as follows:
Change from baseline was calculated as the value at Week 96 minus the value at Baseline. |
Baseline; Week 96
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie del fegato
- Epatite, virale, umana
- Infezioni da Hepadnaviridae
- Infezioni da virus del DNA
- Infezioni da enterovirus
- Infezioni da Picornaviridae
- Epatite B
- Epatite
- Epatite A
- Epatite B, cronica
- Epatite cronica
Altri numeri di identificazione dello studio
- GS-US-320-4018
- 2016-003632-20 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Epatite cronica B
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Northwestern UniversityNational Cancer Institute (NCI)Attivo, non reclutanteLinfoma diffuso a grandi cellule B | Linfoma diffuso a grandi cellule B, non altrimenti specificato | Linfoma a cellule B di alto grado, non altrimenti specificato | Linfoma a grandi cellule B ricco di cellule T/istiociti | Linfoma a cellule B di alto grado con riarrangiamenti di MYC e BCL2... e altre condizioniStati Uniti
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Nathan DenlingerBristol-Myers SquibbReclutamentoLinfoma non Hodgkin a cellule B ricorrente | Linfoma diffuso a grandi cellule B-ricorrente | Linfoma follicolare ricorrente | Linfoma ricorrente a cellule B di alto grado | Linfoma primario mediastinico a grandi cellule B-ricorrente | Linfoma non Hodgkin indolente a cellule B trasformato in linfoma... e altre condizioniStati Uniti
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National Cancer Institute (NCI)Attivo, non reclutanteLinfoma diffuso ricorrente a grandi cellule B Tipo a cellule B attivato | Linfoma diffuso a grandi cellule B refrattario Tipo di cellule B attivatoStati Uniti, Arabia Saudita
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Curocell Inc.ReclutamentoLinfoma a cellule B di alto grado | Linfoma diffuso a grandi cellule B (DLBCL) | Linfoma primario a grandi cellule B del mediastino (PMBCL) | Linfoma follicolare trasformato (TFL) | Linfoma refrattario a grandi cellule B | Linfoma a grandi cellule B recidivatoCorea, Repubblica di
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); AmgenAttivo, non reclutanteLinfoma diffuso ricorrente a grandi cellule B | Linfoma diffuso a grandi cellule B refrattario | CD20 Positivo | Linfoma diffuso a grandi cellule B stadio I | Linfoma diffuso a grandi cellule B stadio II | Linfoma diffuso a grandi cellule B stadio III | Linfoma diffuso a grandi cellule B stadio IVStati Uniti
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First Affiliated Hospital Xi'an Jiaotong UniversityEureka Therapeutics Inc.SconosciutoLinfoma CD19+, cellule B | Leucemia CD19+, cellule BCina
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Lapo AlinariReclutamentoLinfoma ricorrente a cellule B di alto grado con riarrangiamenti di MYC, BCL2 e BCL6 | Linfoma refrattario a cellule B di alto grado con riarrangiamenti di MYC, BCL2 e BCL6 | Linfoma ricorrente a cellule B di alto grado con riarrangiamenti di MYC e BCL2 o BCL6 | Linfoma refrattario a cellule... e altre condizioniStati Uniti
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Ohio State University Comprehensive Cancer CenterReclutamentoLinfoma diffuso a grandi cellule B | Linfoma a cellule B di alto grado | Linfoma diffuso a grandi cellule B, non altrimenti specificato | Linfoma diffuso a grandi cellule B Tipo di cellule B del centro germinaleStati Uniti
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University of NebraskaBristol-Myers SquibbReclutamentoLinfoma follicolare | Linfoma non Hodgkin refrattario | Linfoma a cellule B di alto grado | DLBCL - Linfoma diffuso a grandi cellule B | Linfoma non Hodgkin recidivato | Linfoma mediastinico a grandi cellule B | Linfoma non Hodgkin a cellule B indolenteStati Uniti
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University Hospital, CaenCNRS, UMR ISTCT 6301, LDM-TEP Groupe, GIP Cyceron, Caen, FranceCompletatoPazienti con leucemia linfocitica cronica B non trattata o linfoma diffuso a grandi cellule BFrancia
Prove cliniche su TAF
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Gilead SciencesReclutamentoInfezione da HIV-1Stati Uniti, Tailandia, Uganda, Sud Africa
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Gilead SciencesCompletatoInfezione da HIV-1Stati Uniti, Repubblica Dominicana, Porto Rico, Tailandia
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Gilead SciencesNon ancora reclutamento
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Gilead SciencesReclutamentoInfezione da HIV-1Stati Uniti, Francia, Canada
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Gilead SciencesCompletatoHBV | Infezioni croniche da HBVCina
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Gilead SciencesCompletato
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Huashan HospitalThe First Affiliated Hospital with Nanjing Medical University; Peking University... e altri collaboratoriReclutamento
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Tulika Singh, MDGilead SciencesReclutamento
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Gilead SciencesCompletatoHBV | Infezioni croniche da HBVCina
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Gilead SciencesCompletatoEpatite cronica B HBeAg-negativaHong Kong, Stati Uniti, Regno Unito, Canada, Australia, Spagna, Taiwan, India, Giappone, Polonia, Romania, Federazione Russa, Corea, Repubblica di, Italia, Nuova Zelanda, Francia, Tacchino