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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337479
• Other study ID #: AI463-049
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: April 18, 2011
• Start date: February 2003
• Est. completion date: September 2010

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1097
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups)	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	data is collected every 6 months	Yes
Secondary	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		Every 6 months	No
Secondary	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		Every 6 months	No
Secondary	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		Every 6 months	No
Secondary	To determine the number of anti-HBV medications following enrollment in AI463049 by the phase III treatment group		Every 6 months	No
Secondary	To determine all cause mortality by the phase III treatment group		Every 6 months	No
Secondary	To determine HBV-related mortality by the phase III treatment group		Every 6 months	No
Secondary	To determine Non-hepatic malignancies by the phase III treatment group		Every 6 months	No

External Links

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