Suboptimal Responders to Adefovir Switching to Entecavir
|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.|
|ClinicalTrials.gov Identifier: NCT00718887|
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : February 11, 2013
Last Update Posted : February 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B, Chronic||Drug: Entecavir Drug: Adefovir/Entecavir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||228 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparative Study of the Week 12 Antiviral Efficacy and Safety of Switching to Entecavir vs. Continuing Adefovir Treatment in Adults With Chronic Hepatitis B and Suboptimal Response to Adefovir|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||January 2011|
|Experimental: Entecavir, 0.5 mg QD||
Tablets, Oral, 0.5 mg, once daily (QD), 52 weeks
Adefovir, 10 mg QD/Entecavir, 0.5 mg QD
Tablets, Oral, 10-mg adefovir QD for 12 weeks followed by 0.5-mg entecavir QD for a maximum of 52 weeks
- Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing [ Time Frame: At Week 12 from Day 1 ]HBV DNA Level <50 IU/mL=approximately 300 copies/mL.
- Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing [ Time Frame: At Week 48 from Day 1 ]HBV=hepatitis B virus. HBV DNA Level <50 IU/mL=approximately 300 copies/mL.
- Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing [ Time Frame: At Weeks 12 and 48 from Day 1 ]HBV=hepatitis B virus
- Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT) [ Time Frame: At Weeks 12 and 48 from Day 1 ]ULN=upper limit of normal. ALT normalization= ≤1*ULN, among participants with baseline ALT >1*ULN
- Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion [ Time Frame: At Weeks 12 and 48 from Day 1 ]
- Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion [ Time Frame: At Weeks 12 and 48 from Day 1 ]
- Number of Participants With Genotypic Resistance to Entecavir [ Time Frame: At Week 48 from Day 1 ]
- Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation [ Time Frame: Continually from Day 1 through Week 48, and through 24-week follow-up period ]AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug.
- Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results [ Time Frame: Day 1 through Week 48 ]Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes.
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): NCT00718887
|Beijing, Beijing, China, 100011|
|Guiyang, Guizhou, China, 550004|
|Nanjing, Jiangsu, China, 210002|
|Nanchang, Jiangxi, China, 330006|
|Changchun, Jilin, China, 130021|
|Shenyang, Liaoning, China, 110004|
|Shanghai, Shanghai, China, 200235|
|Shanghai, Shanghai, China|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|