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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:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01337479
First received: April 15, 2011
Last updated: April 18, 2011
Last verified: April 2011
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine the number of anti-HBV medications following enrollment in AI463049 by the phase III treatment group [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • To determine all cause mortality by the phase III treatment group [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • To determine HBV-related mortality by the phase III treatment group [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • To determine Non-hepatic malignancies by the phase III treatment group [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337479

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01337479     History of Changes
Other Study ID Numbers: AI463-049
Study First Received: April 15, 2011
Last Updated: April 18, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013