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

NCT00065507 | Completed Phase 3 Results

• 1 other identifier: AI463-048
• Study Type: interventional
• Target: 195
• Locations: 17 countries
• Sites: 61

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.

Conditions

Hepatitis B

Keywords

hepatic decompensation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 24

Secondary Outcomes (27)

• Change From Baseline in HBV DNA by PCR at Week 48

  Baseline, Week 48

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

  Week 24

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

  Week 48

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

  Week 24, Week 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

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

Study Arms (2)

A1

EXPERIMENTAL

Drug: Entecavir (ETV)

A2

ACTIVE COMPARATOR

Drug: Adefovir (ADV)

Interventions

Entecavir (ETV) DRUG

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

Also known as: Baraclude, BMS-200475

A1

Adefovir (ADV) DRUG

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

A2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Child-Pugh (CP) score \>= 7
• Hepatitis B virus (HBV) viremia

You may not qualify if:

• Alanine aminotransferase (ALT) \> 15 x upper limit of normal (ULN)
• Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/hepatitis D virus (HDV) coinfection

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (61)

Research And Education, Inc.

San Diego, California, 92115, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, 06520, United States

Location

University Of Miami School Of Medicine

Miami, Florida, 33136, United States

Location

Pediatric Gasteroenterology

Atlanta, Georgia, 30342, United States

Location

Hawaii Medical Center East

Honolulu, Hawaii, 96817, United States

Location

Indiana University Med Center

Indianapolis, Indiana, 46202-5121, United States

Location

The Cht Liver Research Center

Louisville, Kentucky, 40292, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Henry Ford Health System Irb

Detroit, Michigan, 48202, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia Presbyterian Medical Center (Cpmc)

New York, New York, 10032, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Ut Southwestern Medical Center

Dallas, Texas, 75390-9151, United States

Location

Mcguire Dvamc

Richmond, Virginia, 23249, United States

Location

Local Institution

Porto Alegre - Rs, Rio Grande do Sul, 90035-003, Brazil

Location

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Sao Paulo - Sp, São Paulo, 05403-900, Brazil

Location

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São Paulo, São Paulo, 01246-000, Brazil

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São Paulo, São Paulo, 01246-903, Brazil

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Calgary, Alberta, T2N 4N1, Canada

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Vancouver, British Columbia, V5Z 1H2, Canada

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Clichy, 92118, France

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Strasbourg, 67100, France

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Athens, 11522, Greece

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Athens, 11527, Greece

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Athens, 15127, Greece

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Thessaloniki, 54006, Greece

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Thessaloniki, 570 10, Greece

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Tai Po, Hong Kong

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Hyderabad, Andhra Pradesh, 500082, India

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Kolkata, 700020, India

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Lucknow, 226014, India

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New Delhi, 110002, India

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Jakarta, 10430, Indonesia

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Cebu, 6000, Philippines

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Manila, 1008, Philippines

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Bydgoszcz, 85-030, Poland

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Chorzów, 41-500, Poland

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Krakow, 31-202, Poland

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Lodz, 91-347, Poland

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Moscow, 115446, Russia

Location

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Moscow, 117333, Russia

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Smolensk, 214018, Russia

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Singapore, 119228, Singapore

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Singapore, 169608, Singapore

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Singapore, 308433, Singapore

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Singapore, 529889, Singapore

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Observatory, Western Cape, 7925, South Africa

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Paarl, Western Cape, 7620, South Africa

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Changhua, 500, Taiwan

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Taichung, 404, Taiwan

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Taipei, 100, Taiwan

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Taoyuan District, 333, Taiwan

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Tianan, 704, Taiwan

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Hat Yai, 90110, Thailand

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Adana, 01330, Turkey (Türkiye)

Location

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Izmir, 35100, Turkey (Türkiye)

Location

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London, Greater London, NW3 2QG, United Kingdom

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis B

Interventions

entecavir; adefovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2003
• First Posted: July 29, 2003
• Study Start: August 1, 2003
• Primary Completion: October 1, 2008
• Study Completion: May 1, 2013
• Last Updated: June 24, 2013
• Results First Posted: July 2, 2010

Record last verified: 2013-06

Locations

BR (4); GR (5); US (16); FR (2); HK (1); RU (3); ZA (2); CA (2); TW (5); PH (2); PL (4); ID (1); TU (2); IN (4); SG (4); TH (3); GB (1)