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Completed

NCT Number: NCT01337479

A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials

The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

About this study

Observational Model: Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.

Number of groups/cohorts: 1 (All subjects were observed in the same manner).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.

Treatment and study plan

Primary outcomes

  1. The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups)

    Time frame: data is collected every 6 months

    defined as follows:

    • Hepatic cirrhosis (Diagnosis requires biopsy or imaging study)
    • Esophageal Varices (Grade 1 or higher on endoscopy or barium swallow)
    • Bleeding esophageal varices
    • Ascites (Present on physical exam or imaging study)
    • Hepatic encephalopathy (≥ Stage 2)
    • Hepatocellular carcinoma
    • Spontaneous bacterial peritonitis
    • Gastric varices
    • Bleeding gastric varices
    • Hepatorenal syndrome

Secondary outcomes

  1. To determine the proportion of subjects who have a HBV Deoxyribonucleic acid (DNA) by Polymerase chain reaction (PCR) of < 300 copies/mL over the AI463049 follow-up period by the phase III treatment group

    Time frame: Every 6 months

  2. To determine the proportion of subjects who have Alanine transaminase (ALT) ≤ 1.0 x Upper limit of normal (ULN) over the AI463049 follow-up period by the phase III treatment group

    Time frame: Every 6 months

  3. To determine the proportion of subjects who were Hepatitis B e antigen (HBeAg) positive at the beginning of Phase III trials who have HBeAg loss or HBe seroconversion over the AI463049 follow-up period by the phase III treatment group

    Time frame: Every 6 months

  4. To determine the number of anti-HBV medications following enrollment in AI463049 by the phase III treatment group

    Time frame: Every 6 months

  5. To determine all cause mortality by the phase III treatment group

    Time frame: Every 6 months

  6. To determine HBV-related mortality by the phase III treatment group

    Time frame: Every 6 months

  7. To determine Non-hepatic malignancies by the phase III treatment group

    Time frame: Every 6 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Long-Term Assessment of Treatment Outcomes With Entecavir and Lamivudine for Chronic Hepatitis B Infection in Patients Who Have Enrolled in Phase III Entecavir Trials

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Apr 19, 2011
Registry last updated
Apr 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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