- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01063036
Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment
25 novembre 2014 aggiornato da: Bristol-Myers Squibb
A Study of the Safety and Efficacy of Entecavir Plus Tenofovir in Adults With Chronic Hepatitis B Virus Infection With Previous Nucleoside/Nucleotide Treatment Failure
The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
144
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Clichy, Francia, 92110
- Local Institution
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Lyons Cedex 04, Francia, 69317
- Local Institution
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Orleans Cedex 2, Francia, 45067
- Local Institution
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Strasbourg, Francia, 67000
- Local Institution
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Berlin, Germania, 13353
- Local Institution
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Berlin, Germania, 10969
- Local Institution
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Hamburg, Germania, 20246
- Local Institution
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Hamburg, Germania, 20099
- Local Institution
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Hannover, Germania, 30625
- Local Institution
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Heindelberg, Germania, 69120
- Local Institution
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Munchen, Germania, 81675
- Local Institution
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Tubingen, Germania, 72076
- Local Institution
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Bagno A Ripoli (Fi), Italia, 50012
- Local Institution
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Bari, Italia, 70124
- Local Institution
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Foggia, Italia, 71100
- Local Institution
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Milano, Italia, 20122
- Local Institution
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Amsterdam, Olanda, 1105 AZ
- Local Institution
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Arnhem, Olanda, 6815 AD
- Local Institution
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Rotterdam, Olanda, 3015 CE
- Local Institution
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Kielce, Polonia, 25-317
- Local Institution
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Krakow, Polonia, 31-531
- Local Institution
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Lodz, Polonia, 91-347
- Local Institution
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Wroclaw, Polonia, 50-349
- Local Institution
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Bucuresti, Romania, 021105
- Local Institution
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Burcuresti, Romania, 022328
- Local Institution
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Timisoara, Romania, 300 002
- Local Institution
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Barcelona, Spagna, 08025
- Local Institution
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Valencia, Spagna, 46014
- Local Institution
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-e antigen(HBeAg)-negative or HBeAg-positive
- Subjects must have a treatment failure to their current nucleoside/ nucleotide treatment regimen
- Prior entecavir and/or tenofovir monotherapy is allowed
- Subjects must have compensated liver function
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Evidence of decompensated cirrhosis
- Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
- Moderate or severe renal impairment
- Recent history of pancreatitis
- Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks of being assigned to study drug into this study
- Prior entecavir/tenofovir combination therapy
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Entecavir + Tenofovir
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Tablets, Oral, 1 mg, once daily, 96 weeks
Altri nomi:
Tablets, Oral, 300 mg, once daily, 96 weeks
Altri nomi:
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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 a Virologic Response at Week 48 - Treated Population
Lasso di tempo: Week 48
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Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL.
Percentage was calculated as number of participants with virologic response at Week 48 divided by the number of treated participants.
Treated participants were evaluated using non-completer (NC) = failure (F).
The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay, in a central laboratory.
The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL.
HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.
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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 a Virologic Response at Week 24 and at Week 96 - Treated Population
Lasso di tempo: Week 24, Week 96
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Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL.
Percentage was calculated as number of participants with virologic response at Week 24, Week 96 divided by the number of treated participants.
Treated participants were evaluated using non-completer (NC) = failure (F).
The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay.
The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL.
HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.
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Week 24, Week 96
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Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population
Lasso di tempo: Baseline to Weeks 12, 24, 48, 96
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HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay.
The results were reported in log 10 IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL.
HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.
Baseline was Day 1, prior to study drug administration.
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Baseline to Weeks 12, 24, 48, 96
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Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population
Lasso di tempo: Weeks 24, 48, 96
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HBV DNA less than (<) LLD (6 IU/mL) was defined/measured by the COBAS(REGISTERED) TaqMan HPS assay at Weeks 24, 48, and 96.
Percentage was calculated as number of participants with HBV DNA < LLD at Weeks 24, 48, 96 divided by the number of treated participants.
Treated participants were evaluated using non-completer (NC) = failure (F).
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Weeks 24, 48, 96
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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline
Lasso di tempo: Baseline to Weeks 24, 48, and 96
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Loss of HBeAg was defined as being HBeAg-negative at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline.
Method used for HBeAg was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples.
Percentage was calculated as number of participants with HBeAg loss at Weeks 24 and 48 divided by the number of treated participants who were HBeAg-positive at baseline.
Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.
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Baseline to Weeks 24, 48, and 96
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Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline
Lasso di tempo: Baseline, Weeks 24, 48, and 96
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HBe seroconversion was defined as being both HBeAg-negative and HBeAb-positive at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline.
Method used was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples.
Percentage was calculated as number of participants with HBe seroconversion at Weeks 24, 48, and 96 divided by the number of treated participants who were HBeAg-positive at baseline.
Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.
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Baseline, Weeks 24, 48, and 96
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline
Lasso di tempo: Baseline, Weeks 24, 48, 96
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Loss of HBsAg was defined as being HBsAg-negative at Weeks 24, 48, 96 in those participants who had been HBsAg-positive at baseline.
The method used: Immunoassay - ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma (potassium ethylene diamine tetraacetic acid, lithium or sodium heparinized).
Percentage calculated as number of participants with a HBsAg loss at Weeks 24, 48, and 96 divided by the number of treated participants who were HBsAg-positive at baseline (participants were not enrolled into the study unless they were positive for HBsAg).
Treated participants (HBsAg-positive at baseline) were evaluated using NC=F.
Baseline was Day 1, before start of study drug.
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Baseline, Weeks 24, 48, 96
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline
Lasso di tempo: Baseline, Weeks 24, 48, and 96
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HBsAg seroconversion was defined as being both HBsAg-negative and HBsAb-positive at Weeks 24, 48, and 96 in those participants who had been HBsAg-positive at baseline.
Percentage was calculated as number of participants with HBs seroconversion at Weeks 24 and 48 divided by the number of treated participants who were HBsAg-positive at baseline.
Positive result for HBsAg was one of the inclusion criteria.
Treated participants (HBsAg positive at baseline) were evaluated using NC=F.
The method used was an Immunoassay testing - ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma [potassium ethylenediaminetetraacetic acid (EDTA), lithium or sodium heparinized].
Baseline was Day 1, before start of study drug.
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Baseline, Weeks 24, 48, and 96
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Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population
Lasso di tempo: Day 1 to last dose of study drug plus 5 days; up to Week 96
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AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Treatment-related=having certain, probable, possible, or missing relationship to study drug.
Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
On-treatment = on Day 1 through last dose of study therapy + 5 days.
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Day 1 to last dose of study drug plus 5 days; up to Week 96
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Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population
Lasso di tempo: Baseline to Weeks 48, 96
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Testing of HBV genotype was performed at baseline for all treated patients and for participants at Weeks 48 and 96 with primary non-response or virologic breakthrough.
Emergent genotypic resistance to study drugs was defined as follows: Emergent = not detected at baseline; entecavir (ETV) resistance (ETVr): participant's sample was to have rtM204V/I/S and any substitution at rtT184, rtS202, or rtM250; tenofovir (TDF) resistance (TDFr) which was based on adefovir (ADV)-mutations: participant's sample was to have rtA181T/V, rtN236T, or (rtA194T and rtM204V/I/S).
Primary non-response was defined as < 1 log10 decrease in HBV DNA from baseline on treatment at or after Week 12. Virologic breakthrough was defined as ≥ 1 log10 increase in HBV DNA over nadir on treatment, either confirmed or last on-treatment followed by discontinuation of study therapy.
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Baseline to Weeks 48, 96
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Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population
Lasso di tempo: Day 1 to last dose of study drug plus 5 days; up to Week 96
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Selected criteria presented in each category.
Upper limit of normal among all laboratory ranges (ULN); Baseline (BL); alanine transaminase (ALT); milligram per deciliter (mg/dL); milliliters per minute (mL/min); greater than (>);greater than, equal to (>=); less than (<).
Creatinine data presented below were confirmed, ie, at least 2 consecutive values.
On-treatment = after Day 1 through last dose of study therapy + 5 days.
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Day 1 to last dose of study drug plus 5 days; up to Week 96
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2010
Completamento primario (Effettivo)
1 novembre 2012
Completamento dello studio (Effettivo)
1 febbraio 2014
Date di iscrizione allo studio
Primo inviato
3 febbraio 2010
Primo inviato che soddisfa i criteri di controllo qualità
4 febbraio 2010
Primo Inserito (Stima)
5 febbraio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
15 dicembre 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 novembre 2014
Ultimo verificato
1 novembre 2014
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
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Inibitori della trascrittasi inversa
- Inibitori della sintesi degli acidi nucleici
- Inibitori enzimatici
- Agenti anti-HIV
- Agenti antiretrovirali
- Tenofovir
- Entecavir
Altri numeri di identificazione dello studio
- AI463-203
- 2009-015705-40 (Numero EudraCT)
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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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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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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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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First Affiliated Hospital Xi'an Jiaotong UniversityEureka Therapeutics Inc.SconosciutoLinfoma CD19+, cellule B | Leucemia CD19+, cellule BCina
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Northwestern UniversityNational Cancer Institute (NCI)ReclutamentoLinfoma mediastinico primario ricorrente (timico) a grandi cellule B | Linfoma a grandi cellule B del mediastino primario (timico) refrattario | Linfoma ricorrente a cellule B di alto grado con riarrangiamenti di MYC, BCL2 e BCL6 | Linfoma refrattario a cellule B di alto grado con riarrangiamenti... e altre condizioniStati Uniti
Prove cliniche su Entecavir
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Sunshine Lake Pharma Co., Ltd.Sospeso
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ShuGuang HospitalBeijing YouAn Hospital; Beijing Ditan Hospital; Shanghai Zhongshan Hospital; Tongji... e altri collaboratoriSconosciutoCirrosi epatica dovuta al virus dell'epatite BCina
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Beijing Friendship HospitalPeking University; Peking University First Hospital; Peking University People's... e altri collaboratoriCompletato
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ShuGuang HospitalShanghai Zhongshan Hospital; Ruijin Hospital; Shanghai Public Health Clinical Center e altri collaboratoriSconosciuto
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Taipei Veterans General Hospital, TaiwanBristol-Myers SquibbCompletatoEpatite B | Linfoma non-HodgkinTaiwan
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Beijing Friendship HospitalPeking University; Peking University First Hospital; Peking University People's... e altri collaboratoriCompletato
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Peking UniversitySconosciuto
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National Taiwan University HospitalSconosciuto
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Sun Yat-sen UniversitySconosciuto
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Sun Yat-sen UniversitySconosciutoNeoplasie allo stomacoCina