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Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Entecavir (ETV)

Adefovir (ADV)

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring hepatic decompensation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Child-Pugh (CP) score >= 7 Hepatitis B virus (HBV) viremia Exclusion Alanine aminotransferase (ALT) > 15 x upper limit of normal (ULN) Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/hepatitis D virus (HDV) coinfection

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Hepatitis B Virus (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24

Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis.

Secondary Outcome Measures

Change From Baseline in HBV DNA by PCR at Week 48

Mean change from baseline in HBV DNA by PCR at Week 48, adjusted for baseline HBV DNA and LVDr Status.

Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24

Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48

Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48

Number of participants in each group who achieved ALT normalization (≤1.0 x upper limit of normal [ULN]) among those with baseline ALT >1.0 x ULN at Weeks 24 and 48

Number of Subjects Achieving Composite Endpoint (HBV DNA < 10*4 Copies/mL by PCR Assay and Normal ALT [≤ 1.0 x ULN]) Through Week 48

>=2-Point Reduction From Baseline in Child-Pugh Score Through Week 48

Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).

Number of Participants With Improvement or No Worsening in Child-Pugh Score From Baseline to Week 48

Number of participants in each group with improvement or no worsening in Child-Pugh score from baseline to Week 48 as measured by improvement or no worsening in Child-Pugh score. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).

Change From Baseline in Child-Pugh Score Through Week 48

Mean change from baseline in Child-Pugh score through week 48. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).

Number of Participants With Improvement in Child-Pugh Class at Week 24 and Week 48

Number of Participants in each group with improvement in Child-Pugh score from baseline to Week 48 as measured by improvement in Child-Pugh class. Improvement in Child-Pugh Class is defined as change from B to A or C to A. Evaluable subjects are subjects with Child-Pugh Class B or C at Baseline. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). Child-Pugh class A to C employs the added score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C.

Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores From Baseline Through Week 48

Adjusted mean change from baseline in MELD score through Week 48 (adjusted for baseline value). The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality.

Improvement or No Worsening in MELD Score Through Week 48

Participants with improvement or no worsening (any decrease or no change from baseline in score) in MELD score through Week 48. The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality.

Mean Changes From Baseline in Quality of Life as Measured by the Short Form 36 (SF-36)

Scoring for the SF-36 will be done using the algorithm developed by the Research ANd Development(RAND) Corporation (a scale of 0-100). Higher scores represent better quality of life. Coding for items with 2-category responses=0 and 100; 3-category=0/50/100; 5-category=0/25/50/75/100; 6-category=0/20/40/60/80/100. Scores of items in the same scale are combined to create the 8 scale scores (physical functioning, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, mental health). Physical and mental health composite scores will be computed for the group.

Mean Changes From Baseline in Quality of Life, as Measured by EuroQol-5D (EQ-5D) at Weeks 24 and 48

The EQ-5D has 5 attributes (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression), each with 3 levels (no problem, some problems, and major problems). This algorithm gives valuation (weights) to each of the 15 responses on the form. Each valuation is a negative number, subtracted from the maximum score of 1 (perfect well being). The overall health index score ranges from 0 (dead) to 1 (perfect health) value scale, and the visual analog scale ranges from 0 to 100. Item weights will be obtained from the EuroQol group.

Change From Baseline in Albumin Through Week 48

Mean albumin levels, and mean change from baseline in albumin, a measure of synthetic liver function. Normal range for albumin = 3.5 - 5.3 g/dL.

Mean Change From Baseline in Prothrombin Time Through Week 48

Mean prothrombin time, and mean change from baseline in prothrombin time, a measure of synthetic liver function. Prothrombin time is the time it takes (in seconds) for a sample of blood to clot. Normal range for prothrombin time (PT) = 10-13 seconds.

Mean Change From Baseline in Total Bilirubin Through Week 48

Mean total bilirubin levels, and mean change from baseline in total bilirubin, a measure of liver secretory function.Normal range for total bilirubin = 0.2 - 1.2 mg/dL.

Change From Baseline in Platelet Count Through Week 48

Mean baseline platelet count and mean change from baseline in platelet count at specific timepoints. Platelets are the smallest particles found in the blood, which play a major role in forming blood clots. Normal range for platelets = 140 - 450 X 10*9 c/L.

Participants Achieving Albumin Normalization Through Week 48

Number of participants who achieved normalization of albumin (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.

Participants Achieving Prothrombin Time Normalization Through Week 48

Number of participants who achieved normalization of prothrombin time (<= 1 x ULN), a measure of liver function, at specific timepoints.

Participants Achieving Total Bilirubin Normalization Through Week 48

Number of participants who achieved normalization of total bilirubin (<= 1 x ULN), a measure of liver function, at specific timepoints.

Participants Achieving Platelet Count Normalization Through Week 48

Number of participants who achieved normalization of platelet count (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.

Number of Hepatocellular Carcinoma (HCC) Events at Different Time Points Through Week 48

HCC-free survival was analyzed using life tables. Measured values show the number of HCC events among treated participants at given time points.

Cumulative Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, HCC, Discontinuations Due to AEs, and Confirmed Creatinine Increase >=0.5 mg/dL

AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Confirmed increase in serum creatinine=values ≥0.5 mg/dL compared with baseline on 2 sequential measures.

Number of Participants With Treatment-Emergent Grade 3/4 Laboratory Abnormalities - Week 48 and Cumulative Data

Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 48 data set was used to evaluate the Week-48 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.

Number of Participants With Alanine Aminotransferase (ALT) Flares - On Treatment

ALT flare=ALT > 2 x baseline and > 10 x upper limit of normal (ULN) by clinical laboratory evaluation. Table includes number of participants with selected clinical events and/or laboratory abnormalities during ALT flares. Selected clinical events during ALT flares=ascites, hepatic encephalopathy, jaundice, bacterial peritonitis. Selected Laboratory abnormalities during ALT flares=international normalized ratio > 1.5 or prothrombin time >= 1.2 x ULN and total bilirubin >2.5 mg/dL and > 1 mg/dL increase from baseline.

Number of Participants With Malignant Neoplasms - On Treatment or During 24-Week Follow-up Period

Data includes type of malignant neoplasm.

Number of Participants Undergoing Liver Transplant - On-Treatment or 24-Week Follow-Up

Full Information

NCT ID

NCT00065507

First Posted

July 28, 2003

Last Updated

June 17, 2013

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00065507

Brief Title

Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

Official Title

Comparison of the Efficacy and Safety of Entecavir Versus Adefovir in Subjects Chronically Infected With Hepatitis B Virus and Evidence of Hepatic Decompensation

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

Keywords

hepatic decompensation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

195 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Entecavir (ETV)

Other Intervention Name(s)

Baraclude, BMS-200475

Intervention Description

Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized

Intervention Type

Drug

Intervention Name(s)

Adefovir (ADV)

Intervention Description

Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized

Primary Outcome Measure Information:

Title

Change From Baseline in Hepatitis B Virus (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24

Description

Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis.

Time Frame

Baseline, Week 24

Secondary Outcome Measure Information:

Title

Change From Baseline in HBV DNA by PCR at Week 48

Description

Mean change from baseline in HBV DNA by PCR at Week 48, adjusted for baseline HBV DNA and LVDr Status.

Time Frame

Baseline, Week 48

Title

Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24

Time Frame

Week 24

Title

Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48

Time Frame

Week 48

Title

Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48

Description

Number of participants in each group who achieved ALT normalization (≤1.0 x upper limit of normal [ULN]) among those with baseline ALT >1.0 x ULN at Weeks 24 and 48

Time Frame

Week 24, Week 48

Title

Number of Subjects Achieving Composite Endpoint (HBV DNA < 10*4 Copies/mL by PCR Assay and Normal ALT [≤ 1.0 x ULN]) Through Week 48

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 48

Title

>=2-Point Reduction From Baseline in Child-Pugh Score Through Week 48

Description

Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Title

Number of Participants With Improvement or No Worsening in Child-Pugh Score From Baseline to Week 48

Description

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 48

Title

Change From Baseline in Child-Pugh Score Through Week 48

Description

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Title

Number of Participants With Improvement in Child-Pugh Class at Week 24 and Week 48

Description

Time Frame

Week 24, Week 48

Title

Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores From Baseline Through Week 48

Description

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Title

Improvement or No Worsening in MELD Score Through Week 48

Description

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 48

Title

Mean Changes From Baseline in Quality of Life as Measured by the Short Form 36 (SF-36)

Description

Time Frame

Baseline, Week 24, Week 48

Title

Mean Changes From Baseline in Quality of Life, as Measured by EuroQol-5D (EQ-5D) at Weeks 24 and 48

Description

Time Frame

Baseline, Week 24, Week 48

Title

Change From Baseline in Albumin Through Week 48

Description

Mean albumin levels, and mean change from baseline in albumin, a measure of synthetic liver function. Normal range for albumin = 3.5 - 5.3 g/dL.

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Title

Mean Change From Baseline in Prothrombin Time Through Week 48

Description

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Title

Mean Change From Baseline in Total Bilirubin Through Week 48

Description

Mean total bilirubin levels, and mean change from baseline in total bilirubin, a measure of liver secretory function.Normal range for total bilirubin = 0.2 - 1.2 mg/dL.

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Title

Change From Baseline in Platelet Count Through Week 48

Description

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Title

Participants Achieving Albumin Normalization Through Week 48

Description

Number of participants who achieved normalization of albumin (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Title

Participants Achieving Prothrombin Time Normalization Through Week 48

Description

Number of participants who achieved normalization of prothrombin time (<= 1 x ULN), a measure of liver function, at specific timepoints.

Time Frame

Baseline, Week4, Week 8, Week 12, Week 24, Week 36, Week 48

Title

Participants Achieving Total Bilirubin Normalization Through Week 48

Description

Number of participants who achieved normalization of total bilirubin (<= 1 x ULN), a measure of liver function, at specific timepoints.

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Title

Participants Achieving Platelet Count Normalization Through Week 48

Description

Number of participants who achieved normalization of platelet count (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Title

Number of Hepatocellular Carcinoma (HCC) Events at Different Time Points Through Week 48

Description

HCC-free survival was analyzed using life tables. Measured values show the number of HCC events among treated participants at given time points.

Time Frame

Week 48

Title

Cumulative Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, HCC, Discontinuations Due to AEs, and Confirmed Creatinine Increase >=0.5 mg/dL

Description

Time Frame

on-treatment events obtained after the start of therapy and no more than 5 days after the last dose of study therapy.

Title

Number of Participants With Treatment-Emergent Grade 3/4 Laboratory Abnormalities - Week 48 and Cumulative Data

Description

Time Frame

Week 48=all on-treatment laboratory measurements up to Week 48. Cumulative data = on-treatment laboratory measurements obtained after the start of therapy and no more than 5 days after the last dose of study therapy.

Title

Number of Participants With Alanine Aminotransferase (ALT) Flares - On Treatment

Description

Time Frame

On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date.

Title

Number of Participants With Malignant Neoplasms - On Treatment or During 24-Week Follow-up Period

Description

Data includes type of malignant neoplasm.

Time Frame

On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up.

Title

Number of Participants Undergoing Liver Transplant - On-Treatment or 24-Week Follow-Up

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Research And Education, Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92115

Country

United States

Facility Name

California Pacific Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Yale University School Of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

University Of Miami School Of Medicine

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Pediatric Gasteroenterology

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Hawaii Medical Center East

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96817

Country

United States

Facility Name

Indiana University Med Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202-5121

Country

United States

Facility Name

The Cht Liver Research Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40292

Country

United States

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Henry Ford Health System Irb

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Mount Sinai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Columbia Presbyterian Medical Center (Cpmc)

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Integris Baptist Medical Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Baylor University Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Ut Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9151

Country

United States

Facility Name

Mcguire Dvamc

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

Local Institution

City

Porto Alegre - Rs

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo - Sp

State/Province

Sao Paulo

ZIP/Postal Code

05403-900

Country

Brazil

Facility Name

Local institution

City

Sao Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

01246-903

Country

Brazil

Facility Name

Local Institution

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N1

Country

Canada

Facility Name

Local Institution

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1H2

Country

Canada

Facility Name

Local Institution

City

Clichy Cedex

ZIP/Postal Code

92118

Country

France

Facility Name

Local Institution

City

Strasbourg

ZIP/Postal Code

67100

Country

France

Facility Name

Local institution

City

Athens

ZIP/Postal Code

11522

Country

Greece

Facility Name

Local Institution

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Local Institution

City

Athens

ZIP/Postal Code

15127

Country

Greece

Facility Name

Local Instituition

City

Thessaloniki

ZIP/Postal Code

54006

Country

Greece

Facility Name

Local Institution

City

Thessaloniki

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Local Institution

City

Tai Po

Country

Hong Kong

Facility Name

Local Institution

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500082

Country

India

Facility Name

Local Institution

City

Kolkata

ZIP/Postal Code

700020

Country

India

Facility Name

Local Institution

City

Lucknow

ZIP/Postal Code

226014

Country

India

Facility Name

Local Institution

City

New Delhi

ZIP/Postal Code

110002

Country

India

Facility Name

Local Institution

City

Jakarta

ZIP/Postal Code

10430

Country

Indonesia

Facility Name

Local Institution

City

Cebu

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Local Institution

City

Manila

ZIP/Postal Code

1008

Country

Philippines

Facility Name

Local Institution

City

Bydgoszcz

ZIP/Postal Code

85-030

Country

Poland

Facility Name

Local Institution

City

Chorzow

ZIP/Postal Code

41-500

Country

Poland

Facility Name

Local Institution

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

Local Institution

City

Lodz

ZIP/Postal Code

91-347

Country

Poland

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

115446

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

117333

Country

Russian Federation

Facility Name

Local Institution

City

Smolensk

ZIP/Postal Code

214018

Country

Russian Federation

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

119228

Country

Singapore

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

529889

Country

Singapore

Facility Name

Local Institution

City

Observatory

State/Province

Western Cape

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Local Institution

City

Paarl

State/Province

Western Cape

ZIP/Postal Code

7620

Country

South Africa

Facility Name

Local Institution

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Local Institution

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Local Institution

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Local Institution

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Local Institution

City

Tianan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Local Institution

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Local Institution

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Local Institution

City

Hatyai

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Local Institution

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Local Institution

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Local Institution

City

London

State/Province

Greater London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://www.bms.com/studyconnect/Pages/home.aspx

Description

BMS clinical trial educational resource

Learn more about this trial

Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

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Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

Hepatitis B

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial