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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01337479
First Posted: April 19, 2011
Last Update Posted: April 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
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.

Condition
Hepatitis B

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • To determine the number of anti-HBV medications following enrollment in AI463049 by the phase III treatment group [ Time Frame: Every 6 months ]
  • To determine all cause mortality by the phase III treatment group [ Time Frame: Every 6 months ]
  • To determine HBV-related mortality by the phase III treatment group [ Time Frame: Every 6 months ]
  • To determine Non-hepatic malignancies by the phase III treatment group [ Time Frame: Every 6 months ]

Enrollment: 1097
Study Start Date: February 2003
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants of specific phase III entecavir studies
Those who participated in the specific Phase III entecavir studies as described; all had Hepatitis B infections

Detailed Description:

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
Criteria

Inclusion Criteria:

  • All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337479


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01337479     History of Changes
Other Study ID Numbers: AI463-049
First Submitted: April 15, 2011
First Posted: April 19, 2011
Last Update Posted: April 19, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents