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A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects with Incomplete Response to Lamivudine



A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects with Incomplete Response to Lamivudine

For Condition: Chronic Hepatitis B
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: The purpose of this clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: - Male and female subjects =/> 16 years of age (or minimum age required in a given country) with history of HBeAg-positive chronic hepatitis B infection; - Incomplete response to current lamivudine therapy; - HBeAg-positive; - Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV); - Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease.
Total Enrollment: 

Location and Contact Information:

Local Investigator
La Jolla,  California,  92037
United States
 

Local Investigator
Orange,  California,  92868
United States
 

Local Investigator
Birmingham,  Alabama,  35294
United States
 

Local Investigator
Royal Oak,  Michigan,  48073
United States
 

Local Investigator
Manhasset,  New York,  11030
United States
 

Local Investigator
Cleveland,  Ohio,  44125
United States
 

Local Investigator
Atlanta,  Georgia,  30322
United States
 

Local investigator
Dallas,  Texas,  75235
United States
 

Local Investigator
Fairfax,  Virginia,  22031
United States
 

Local Investigator
Nashville,  Tennessee,  37211
United States
 

Local Investigator
Atlanta,  Georgia,  30309
United States
 

Local Investigator
Ann Arbor,  Michigan,  48109
United States
 

Local Investigator
St. Paul,  Minnesota,  55114
United States
 

Local Investigator
New York City,  New York,  10029
United States
 

Local Investigator
Rochester,  New York,  14642
United States
 

Local Investigator
New York City,  New York,  10032
United States
 

Local Investigator
Miami,  Florida,  33136
United States
 

Local Investigator
Durham,  North Carolina,  27710
United States
 

Local Investigator
Pittsburgh,  Pennsylvania,  15213
United States
 

Local Investigator
Dundalk,  Maryland,  21205
United States
 

Local Investigator
San Diego,  California,  92115
United States
 

Local Investigator
Los Angeles,  California,  90095
United States
 

Local Investigator
Iowa City,  Iowa,  52242
United States
 

Local Investigator
Philadelphia,  Pennsylvania,  19104
United States
 

Local Investigator
San Francisco,  California,  94115
United States
 

Local Investigator
Chicago,  Illinois,  60622
United States
 

Local Investigator
New York City,  New York,  10003
United States
 

Local Investigator
Richmond,  Virginia,  23249
United States
 

Local Investigator
Tucson,  Arizona,  85724
United States
 

Local Investigator
Providence,  Rhode Island,  02908
United States
 

Local Investigator
Miami,  Florida,  33140
United States
 

Local Investigator
Chicago,  Illinois,  60612
United States
 

Local Investigator
Boston,  Massachusetts,  02111
United States
 

Local Investigator
New York City,  New York,  10003
United States
 

Local Investigator
Farmington,  Connecticut,  06030
United States
 

Local Investigator
Honolulu,  Hawaii,  96820
United States
 

Local Investigator
New Orleans,  Louisiana,  70112
United States
 

Local Investigator
Charlotte,  North Carolina,  28203
United States
 

Local Investigator
Worcester,  Massachusetts,  01655
United States
 

Local Investigator
Los Angeles,  California,  90048
United States
 


Additional Information:
Study ID Numbers:
  AI463-026; 
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036608

Other Chronic Hepatitis B Studies:
1. An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options

2. Evaluate Efficacy, Safety and PK of Adefovir Dipivoxil Liquid Suspension in Patients with Chronic Hepatitis B

3. Lamivudine and Adefovir to Treat Chronic Hepatitis B Infection in People With and Without HIV Infection

4. Lamivudine for Chronic Hepatitis B

5. Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B

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A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects with Incomplete Response to Lamivudine

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