Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
13 marca 2013 zaktualizowane przez: Bristol-Myers Squibb
A Comparative Study of Chronic Hepatitis B Subjects Treated With Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy in Adults Who Are Treatment-Naive to Nucleosides and Nucleotides: The BE-LOW Study
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy.
Safety will also be studied.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
669
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Gauteng
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Pretoria, Gauteng, Afryka Południowa, 0001
- Local Institution
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Western Cape
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Bellville, Western Cape, Afryka Południowa, 7530
- Local Institution
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N1 City Goodwood, Western Cape, Afryka Południowa, 7463
- Local Institution
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Buenos Aires
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Ciudad De Buenos Aires, Buenos Aires, Argentyna, C1121ABE
- Local Institution
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Ciudad De Buenos Aires, Buenos Aires, Argentyna, C1181ACH
- Local Institution
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Ciudad De Buenos Aires, Buenos Aires, Argentyna, C1282AEN
- Local Institution
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Prov De Santa
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Rosario, Prov De Santa, Argentyna, S2000PBJ
- Local Institution
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New South Wales
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Westmead Nsw, New South Wales, Australia, 2145
- Local Institution
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Victoria
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Clayton Vic, Victoria, Australia, 3168
- Local Institution
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Fitzroy, Victoria, Australia, 3065
- Local Institution
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Heidelberg, Victoria, Australia, 3084
- Local Institution
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Prahan, Victoria, Australia, 3004
- Local Institution
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazylia, 30150
- Local Institution
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Rio Grande Do Sul
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Porto Alegre Rs, Rio Grande Do Sul, Brazylia, 90035
- Local Institution
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Moscow, Federacja Rosyjska, 105275
- Local Institution
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Moscow, Federacja Rosyjska, 115446
- Local Institution
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Moscow, Federacja Rosyjska, 117593
- Local Institution
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Smolensk, Federacja Rosyjska, 214018
- Local Institution
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St. Petersburg, Federacja Rosyjska, 194044
- Local Institution
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St. Petersburg, Federacja Rosyjska, 190103
- Local Institution
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St. Petersburg, Federacja Rosyjska, 191167
- Local Institution
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St. Petersburg, Federacja Rosyjska, 191163
- Local Institution
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Grenoble Cedex 09, Francja, 38043
- Local Institution
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Marseille Cedex 08, Francja, 13285
- Local Institution
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Paris, Francja, 75014
- Local Institution
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Paris Cedex 12, Francja, 75571
- Local Institution
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Paris Cedex 13, Francja, 75013
- Local Institution
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Strasbourg, Francja, 67090
- Local Institution
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Lucknow, Indie, 226014
- Local Institution
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Ludhiana, Indie, 141001
- Local Institution
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Vellore, Indie, 632004
- Local Institution
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, Indie, 500082
- Local Institution
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Bornova Izmir, Indyk, 35100
- Local Institution
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Cebeci Ankara, Indyk, 06620
- Local Institution
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Sihhiye Ankara, Indyk, 06100
- Local Institution
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Trabzon, Indyk, 61080
- Local Institution
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Alberta
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Calgary, Alberta, Kanada, T2N 4Z6
- Local Institution
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 1H2
- Local Institution
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Manitoba
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Winnipeg, Manitoba, Kanada, R3E 3P4
- Local Institution
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Ontario
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Toronto, Ontario, Kanada, M5G 2N2
- Local Institution
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Toronto, Ontario, Kanada, M5T 2S8
- Local Institution
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Toronto, Ontario, Kanada, M3N 2V7
- Local Institution
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Durango, Meksyk, 34229
- Local Institution
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Bialystok, Polska, 15-540
- Local Institution
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Chorzow, Polska, 41-500
- Local Institution
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Krakow, Polska, 31-531
- Local Institution
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Lublin, Polska, 20-081
- Local Institution
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Warszawa, Polska, 01-201
- Local Institution
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California
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Los Angeles, California, Stany Zjednoczone, 90017
- Sergio E. Rojter
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San Diego, California, Stany Zjednoczone, 92105
- Tuan Nguyen, Md
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San Jose, California, Stany Zjednoczone, 95128
- San Jose Gastroenterology
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06510
- Yale University School of Medicine
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Florida
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Miami, Florida, Stany Zjednoczone, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30309
- Digestive Healthcare of Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30308
- Atlanta Gastroenterology Associates
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21229
- Digestive Disease Associates, P.A.
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Laurel, Maryland, Stany Zjednoczone, 20707
- Maryland Digestive Disease Research, Llc
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02215
- Beth Israel Deaconess Medical Center
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- University of Michigan Health System
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New York
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Flushing, New York, Stany Zjednoczone, 11355
- Sing Chan, MD
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Manhasset, New York, Stany Zjednoczone, 11030
- North Shore University
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New York, New York, Stany Zjednoczone, 10003
- Beth Israel Medical Center
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New York, New York, Stany Zjednoczone, 10029
- Mount Sinai School of Medicine
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New York, New York, Stany Zjednoczone, 10016
- Concorde Medical Group
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Antella Firenze, Włochy, 50012
- Local Institution
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Brescia, Włochy, 25123
- Local Institution
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Pisa, Włochy, 56124
- Local Institution
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Roma, Włochy, 00149
- Local Institution
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
16 lat i starsze (Dziecko, Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Chronic hepatitis B virus (HBV) infection (hepatitis B e antigen [HbeAg]-positive or negative) disease
- Nucleoside- and nucleotide-naive
- Males or females ≥16 years of age (or minimum age of consent in a given country)
- Compensated liver function
- HBV DNA >1.72*10*5*IU/mL (approximately 10*6*copies/mL) for HbeAg-positive participants
- HBV DNA >1.72*10*4*IU/mL (approximately 10*5*copies/mL) for Hbe-Ag-negative participants
- Alanine aminotransferase level ≥*upper limit of normal (ULN) and ≤10*ULN
Exclusion Criteria:
- Evidence of decompensated cirrhosis
- Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
- Laboratory values out of protocol-specified range
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: TDF 0.5 mg
TDF=tenofovir
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Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
Inne nazwy:
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Eksperymentalny: ETV 0.5 mg +TDF 300 mg
ETV=entecavir; TDF=tenofovir
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Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
Ramy czasowe: At Week 96
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HBV DNA levels <50 IU/mL=approximately 300 copies/mL.
Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F).
All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
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At Week 96
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status
Ramy czasowe: At Weeks 48 and 96
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HBV DNA levels <50 IU/mL=approximately 300 copies/mL.
Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F).
All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
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At Weeks 48 and 96
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Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96
Ramy czasowe: At Weeks 48 and 96
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LOQ=lower limit of quantitation.
LOQ=29 IU/mL, or approximately 169 copies/mL.
LOQ is the level above which quantitative results may be obtained with a specified degree of confidence.
The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.
Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F).
All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
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At Weeks 48 and 96
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Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96
Ramy czasowe: At Weeks 48 and 96
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LOD=Lower limit of detection.
LOD) LOD=10 IU/mL, or approximately 58 copies/mL.
LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence).
The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F).
All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
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At Weeks 48 and 96
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Mean Log 10 HBV DNA at Weeks 48 and 96
Ramy czasowe: Baseline, Weeks 48 and 96
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HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay.
Reduction in Log 10 HBV count=reduced viral load.
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Baseline, Weeks 48 and 96
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Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96
Ramy czasowe: At Weeks 48 and 96
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ALT normalization= ≤1*upper limit of normal (ULN).
Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F).
All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
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At Weeks 48 and 96
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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96
Ramy czasowe: At Weeks 48 and 96
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HBeAg is a hepatitis B viral protein and is an indicator of active viral replication.
Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F).
All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
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At Weeks 48 and 96
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Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96
Ramy czasowe: At Weeks 48 and 96
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HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb).
HBeAg is a hepatitis B viral protein and is an indicator of active viral replication.
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At Weeks 48 and 96
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96
Ramy czasowe: At Weeks 48 and 96
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HBsAg = A part of the hepatitis B virus.
When found in the blood, HBsAg is an early marker of infection.
Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F).
All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
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At Weeks 48 and 96
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Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96
Ramy czasowe: At Weeks 48 and 96
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HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection.
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At Weeks 48 and 96
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Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96
Ramy czasowe: At Weeks 48 and 96
|
Using the Roche COBAS TaqMan - HPS assay.
Lower limit of Quantitation (LOQ) is the level above which quantitative results may be obtained with a specified degree of confidence.
The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.
Limits of quantitation are matrix-, method-, and analyte-specific.
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At Weeks 48 and 96
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Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities
Ramy czasowe: From enrollment through Week 100 + 24-week follow-up
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AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.
SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose.
Participants who discontinued the study due to any AEs were recorded.
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From enrollment through Week 100 + 24-week follow-up
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Number of Participants With HBV Resistance Through Week 48
Ramy czasowe: Week 48
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ETVr=entecavir resistance; TDFr=tenofovir resistance.
HBV polymerase using the Trugene® HBV Genotyping Kit.
HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA.
When appropriate, phenotyping will also be used.
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Week 48
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Number of Participants With HBV Resistance at Week 96
Ramy czasowe: Week 96
|
ETVr=entecavir resistance; TFDr=tenofovir resistance.
HBV polymerase using the Trugene® HBV Genotyping Kit.
HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA.
When appropriate, phenotyping will also be used.
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Week 96
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Number of Participants With Virologic Breakthrough at Week 48
Ramy czasowe: Week 48
|
ETVr=entecavir resistance; TFDr=tenofovir resistance.
Virologic breakthrough= confirmed >= 1 log10 increase in HBV DNA from the on-treatment nadir
|
Week 48
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Number of Participants With Virologic Breakthrough at Week 96
Ramy czasowe: Week 96
|
ETVr=entecavir resistance; TFDr=tenofovir resistance.
Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir
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Week 96
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 kwietnia 2007
Zakończenie podstawowe (Rzeczywisty)
1 października 2010
Ukończenie studiów (Rzeczywisty)
1 października 2010
Daty rejestracji na studia
Pierwszy przesłany
11 grudnia 2006
Pierwszy przesłany, który spełnia kryteria kontroli jakości
11 grudnia 2006
Pierwszy wysłany (Oszacować)
12 grudnia 2006
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
15 marca 2013
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
13 marca 2013
Ostatnia weryfikacja
1 marca 2013
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby Układu Pokarmowego
- Zakażenia wirusem RNA
- Choroby wirusowe
- Infekcje
- Infekcje przenoszone przez krew
- Choroby zakaźne
- Choroby wątroby
- Zapalenie wątroby, wirusowe, ludzkie
- Infekcje Hepadnaviridae
- Infekcje wirusami DNA
- Infekcje enterowirusowe
- Infekcje Picornaviridae
- Zapalenie wątroby, przewlekłe
- Zapalenie wątroby typu B
- Zapalenie wątroby
- Wirusowe Zapalenie Wątroby typu A
- Wirusowe zapalenie wątroby typu B, przewlekłe
- Molekularne mechanizmy działania farmakologicznego
- Środki przeciwinfekcyjne
- Środki przeciwwirusowe
- Inhibitory odwrotnej transkryptazy
- Inhibitory syntezy kwasów nukleinowych
- Inhibitory enzymów
- Agenci przeciw HIV
- Środki przeciwretrowirusowe
- Tenofowir
- Entekawir
Inne numery identyfikacyjne badania
- AI463-110
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .