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Nucleoside Analog Reverse Transcriptase Inhibitor
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
Marseille Cedex 08, France
Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment through week 100 + 24-week follow-up
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
See full description
Eligible Conditions
- Chronic Hepatitis B Virus Infection
- Chronic Hepatitis B
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment through week 100 + 24-week follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment through week 100 + 24-week follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
Secondary study objectives
Mean Log 10 HBV DNA at Weeks 48 and 96
Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities
Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: TDF 0.5 mgExperimental Treatment1 Intervention
TDF=tenofovir
Group II: ETV 0.5 mg +TDF 300 mgExperimental Treatment1 Intervention
ETV=entecavir; TDF=tenofovir
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir
Not yet FDA approved
Entecavir
FDA approved
Find a Location
Closest Location:Concorde Medical Group· New York, NY
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,730 Previous Clinical Trials
4,126,801 Total Patients Enrolled
1 Trials studying Chronic Hepatitis B Virus Infection
43 Patients Enrolled for Chronic Hepatitis B Virus Infection