- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00298363
Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
A Phase 2, Double-Blind, Multi-center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus Tenofovir Disoproxil Fumarate, and Entecavir in the Treatment of Chronic Hepatitis B Subjects With Decompensated Liver Disease and in the Prevention of Hepatitis B Recurrence Post-Transplantation
This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver disease. Safety was assessed by evaluating adverse events (AEs) and laboratory abnormalities. Efficacy was assessed by evaluating reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores, reductions in hepatitis B virus (HBV) deoxyribonucleic acid (DNA), changes in liver enzymes, development of drug-resistant mutations, and generation of antibody to virus.
A maximum randomized treatment duration of 168 weeks was planned. Since subjects with decompensated liver disease were enrolled into this study, it was necessary to provide early intervention strategies if profound viral suppression was not expeditiously achieved. For this reason, subjects with a decrease in plasma HBV DNA from baseline of < 2 log_10 copies/mL and plasma HBV DNA > 10,000 copies/mL (or plasma HBV DNA > 1,000 copies/mL for subjects who entered the study with HBV DNA < 10,000 copies/mL) at Week 8 had the option to start open-label FTC/TDF and continue in the study. Subjects with a virologic breakthrough or who had plasma HBV DNA levels remaining > 400 copies/mL (confirmed) at or after 24 weeks of treatment could have been unblinded at the investigator's discretion for selection of alternative anti-HBV therapy that may have included open-label FTC/TDF. If study drug was permanently discontinued, immediate initiation of another anti-HBV regimen was strongly recommended.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N4N1
- Heritage Medical Research Clinic
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British Columbia
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Vancouver, British Columbia, Canada, V5Z1H2
- Vancouver General Hospital
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Vancouver, British Columbia, Canada, V5Z3M9
- The Gordon & Leslie Diamond Centre
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Marseille, France, 13005
- Hôpital Conception
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Berlin, Germany, 13353
- Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
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Heidelberg, Germany, 69120
- Universität Heidelberg
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Mainz, Germany, 55131
- Johannes Gutenberg-Universität
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Athens, Greece, 11527
- General Hospital of Athens "Ippokratio"
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Padova, Italy, 35128
- Universita de Padova
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Udine, Italy, 33100
- Policlinico Universitario
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Bialystok, Poland, 15-540
- Wojewodzki Szpital Specjalistyczny im Dluskeigo
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Bydgoszcz, Poland, 85-030
- Wojewodzki Szpital Obserwacy
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Warsaw, Poland, 01-201
- Wojewodzki Szpital Zakazny
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Singapore, Singapore, 169608
- Singapore General Hospital
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Singapore, Singapore, 308433
- Tan Tock Seng Hospital
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Singapore, Singapore, 529889
- Changi General Hospital
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Singapore, Singapore, 119074
- National University Hospital Dept. of Gastroenterology & Hepatology
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Barcelona, Spain, 08035
- Hospital General Universitari Vall d'Hebron
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Barcelona, Spain, 08036
- Hospital Clinic i Provincial de Barcelona (HCPB)
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Barcelona, Spain, 08907
- Hospital Universitario de Bellvitge
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Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañon
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Valencia, Spain, 46026
- Hospital Universitario y Politécnico La Fe
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Kaoshiung Hsien, Taiwan, 833
- Chang Gung Memorial Hospital - Kaohsiung
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Tainan, Taiwan, 70428
- National Cheng Kung University Hospital
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Taipei, Taiwan, 10650
- Cathay General Hospital
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Taipei City, Taiwan, 114
- Chang-Gung Memorial Hospital
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Istanbul, Turkey, 34899
- Marmara Universitesi School of Medicine
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Izmir, Turkey, 35100
- Ege Universitesi Tip Fakultesi Hastanesi
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California
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Los Angeles, California, United States, 90095
- Pfleger Liver Institute
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San Francisco, California, United States, 94115
- California Pacific Medical Center Research Institute
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Florida
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Miami, Florida, United States, 33136
- University of Miami, Center for Liver Diseases
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Illinois
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Chicago, Illinois, United States, 60612
- Rush Presbyterian - St. Luke's Medical Center
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital and Health System
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New York
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New York, New York, United States, 10032
- Columbia Presbyterian Medical Center
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New York, New York, United States, 10029
- Mt. Sinai School of Medicine/ Mt. Sinai Medical Center
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Virginia
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Fairfax, Virginia, United States, 22031
- Metropolitan Research
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Washington
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Seattle, Washington, United States, 98104
- Virginia Mason Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
A participant was required to meet all of the following inclusion criteria to be eligible for participation in the study:
- Chronic Hepatitis B infection
- 18 through 69 years of age, inclusive
- HBV DNA ≥ 1000 copies/mL
Decompensated liver disease with all of the following:
- CPT score of 7-12 (inclusive) OR history of CPT score ≥ 7 and any CPT at screen ≤ 12
- Serum alanine aminotransferase (ALT) < 10 x the upper limit of the normal range (ULN)
- Hemoglobin ≥ 7.5 g/dL
- Total white blood cell (WBC) count ≥ 1,500/mm^3
- Platelet count ≥ 30,000/mm^3
- Alpha-fetoprotein ≤ 20 ng/mL and ultrasound or other imaging with no evidence of hepatocellular carcinoma (HCC), or alpha-fetoprotein of 21-50 ng/mL and computed tomography (CT)/magnetic resonance imaging (MRI) scan with no evidence of HCC, within 6 months of screening
- Calculated creatinine clearance ≥ 50 mL/min
- Negative human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis D virus (HDV) serologies
- Less than 24 months of total prior adefovir dipivoxil exposure
- Willing and able to provide written informed consent
Exclusion Criteria:
A participant who met any of the following exclusion criteria could not be enrolled in the study:
- Pregnant women, women who were breastfeeding or who believed they may have wished to become pregnant during the course of the study
- Males and females of reproductive potential who were unwilling to use an effective method of contraception during the study
- Prior use of TDF or ETV
- History of variceal bleeding, hepatorenal syndrome, Grade 3 or 4 hepatic encephalopathy, or spontaneous bacterial peritonitis within 60 days of screening
- Grade 2 hepatic encephalopathy at screening
- History of solid organ or bone marrow transplant
- Current use of hepatotoxic drugs, nephrotoxic drugs, or drugs that interfere with renal tubular secretion
- Current therapy with immunomodulators (eg, corticosteroids, interleukin-2, etc.) or investigational drugs
- Diagnosis of proximal tubulopathy
- Use of investigational agent within 30 days prior to screening
- Known hypersensitivity to TDF, FTC, ETV, or formulation excipients of any of the study drug products
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tenofovir DF
TDF 300 mg + FTC/TDF placebo + ETV placebo once daily (QD)
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300-mg tablet QD
Other Names:
Placebo to match FTC/TDF QD
Placebo to match ETV QD
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Experimental: FTC/TDF
FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo QD
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Placebo to match ETV QD
FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet QD
Other Names:
Placebo to match TDF QD
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Experimental: Entecavir
ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo QD
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Placebo to match FTC/TDF QD
Placebo to match TDF QD
0.5-mg or 1-mg tablet QD
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Probability of Tolerability Failure
Time Frame: Baseline to Week 168
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Tolerability failure was defined as permanent discontinuation of study drug due to a treatment-emergent adverse event (AE), including any subject who temporarily discontinued study drug due to an AE and did not restart.
Results are expressed as proportions of participants who experience tolerability failure using the Kaplan-Meier (KM) method of estimation.
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Baseline to Week 168
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Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL
Time Frame: Baseline to Week 168
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Results are expressed as proportions of participants who experience a confirmed increase in serum creatinine of ≥ 0.5 mg/dL from baseline or a confirmed serum phosphorus level < 2.0 mg/dL using the KM method of estimation.
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Baseline to Week 168
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline
Time Frame: Baseline to 48 weeks
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Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 48 HBV DNA log_10 copies/mL.
DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
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Baseline to 48 weeks
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Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline
Time Frame: Baseline to 96 weeks
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Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 96 HBV DNA log_10 copies/mL.
DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
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Baseline to 96 weeks
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Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline
Time Frame: Baseline to 144 weeks
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Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 144 HBV DNA log_10 copies/mL.
DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
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Baseline to 144 weeks
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Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline
Time Frame: Baseline to 168 weeks
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Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 168 HBV DNA log_10 copies/mL.
DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.
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Baseline to 168 weeks
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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
Time Frame: Week 48
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The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 48 was summarized.
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Week 48
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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96
Time Frame: Week 96
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The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 96 was summarized.
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Week 96
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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144
Time Frame: Week 144
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The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 144 was summarized.
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Week 144
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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
Time Frame: Week 168
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The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 168 was summarized.
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Week 168
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Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48
Time Frame: Baseline to Week 48
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Normalized ALT is defined as having a baseline ALT value > the upper limit of the normal range (ULN), and a decrease in ALT value to ≤ ULN at the given time point.
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Baseline to Week 48
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Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96
Time Frame: Baseline to Week 96
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Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.
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Baseline to Week 96
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Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144
Time Frame: Baseline to Week 144
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Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.
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Baseline to Week 144
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Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168
Time Frame: Baseline to Week 168
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Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.
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Baseline to Week 168
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Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48
Time Frame: Baseline to Week 48
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CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features.
CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
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Baseline to Week 48
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Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96
Time Frame: Baseline to Week 96
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CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features.
CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
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Baseline to Week 96
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Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144
Time Frame: Baseline to Week 144
|
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features.
CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
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Baseline to Week 144
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Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168
Time Frame: Baseline to Week 168
|
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features.
CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
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Baseline to Week 168
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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48
Time Frame: Baseline to Week 48
|
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features.
CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
|
Baseline to Week 48
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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96
Time Frame: Baseline to Week 96
|
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features.
CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
|
Baseline to Week 96
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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144
Time Frame: Baseline to Week 144
|
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features.
CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
|
Baseline to Week 144
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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168
Time Frame: Baseline to Week 168
|
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features.
CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
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Baseline to Week 168
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Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48
Time Frame: Baseline to Week 48
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MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
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Baseline to Week 48
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Median Change in MELD Score From Baseline at Week 96
Time Frame: Baseline to Week 96
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MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
|
Baseline to Week 96
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Median Change in MELD Score From Baseline at Week 144
Time Frame: Baseline to Week 144
|
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
|
Baseline to Week 144
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Median Change in MELD Score From Baseline at Week 168
Time Frame: Baseline to Week 168
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MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
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Baseline to Week 168
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Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)
Time Frame: Baseline to Week 48
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Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.
HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
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Baseline to Week 48
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Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)
Time Frame: Baseline to Week 96
|
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.
HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
|
Baseline to Week 96
|
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)
Time Frame: Baseline to Week 144
|
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.
HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
|
Baseline to Week 144
|
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)
Time Frame: Baseline to Week 168
|
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.
HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.
|
Baseline to Week 168
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48
Time Frame: Baseline to Week 48
|
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.
HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
|
Baseline to Week 48
|
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96
Time Frame: Baseline to Week 96
|
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.
HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
|
Baseline to Week 96
|
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144
Time Frame: Baseline to Week 144
|
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.
HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
|
Baseline to Week 144
|
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168
Time Frame: Baseline to Week 168
|
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.
HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.
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Baseline to Week 168
|
In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results
Time Frame: Baseline to Week 168
|
Baseline to Week 168
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
Time Frame: Baseline to Week 168
|
ADV resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation.
|
Baseline to Week 168
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Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
Time Frame: Baseline to Week 168
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LAM resistance mutations are defined as the presence of the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.
|
Baseline to Week 168
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Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
Time Frame: Baseline to Week 168
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ADV resistance mutation + LAM resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation, and the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.
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Baseline to Week 168
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Liver Diseases
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Emtricitabine
- Entecavir
- Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Other Study ID Numbers
- GS-US-174-0108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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