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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR BARACLUDE


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All Clinical Trials for Baraclude

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00065507 ↗ Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation Completed Bristol-Myers Squibb Phase 3 2003-08-01 This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.
NCT00096785 ↗ Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection Completed Bristol-Myers Squibb Phase 3 2004-12-01 The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.
NCT00298363 ↗ Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease. Completed Gilead Sciences Phase 2 2006-04-01 This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver disease. Safety was assessed by evaluating adverse events (AEs) and laboratory abnormalities. Efficacy was assessed by evaluating reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores, reductions in hepatitis B virus (HBV) deoxyribonucleic acid (DNA), changes in liver enzymes, development of drug-resistant mutations, and generation of antibody to virus. A maximum randomized treatment duration of 168 weeks was planned. Since subjects with decompensated liver disease were enrolled into this study, it was necessary to provide early intervention strategies if profound viral suppression was not expeditiously achieved. For this reason, subjects with a decrease in plasma HBV DNA from baseline of < 2 log_10 copies/mL and plasma HBV DNA > 10,000 copies/mL (or plasma HBV DNA > 1,000 copies/mL for subjects who entered the study with HBV DNA < 10,000 copies/mL) at Week 8 had the option to start open-label FTC/TDF and continue in the study. Subjects with a virologic breakthrough or who had plasma HBV DNA levels remaining > 400 copies/mL (confirmed) at or after 24 weeks of treatment could have been unblinded at the investigator's discretion for selection of alternative anti-HBV therapy that may have included open-label FTC/TDF. If study drug was permanently discontinued, immediate initiation of another anti-HBV regimen was strongly recommended.
NCT00371150 ↗ Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection Completed Bristol-Myers Squibb Phase 4 2006-11-01 The purpose of this clinical research study is to develop observational clinical experience with the use of entecavir in participants who are either of Black/African-American race or of Hispanic ethnicity.
NCT00388674 ↗ Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection Completed Bristol-Myers Squibb 2006-12-18 The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.
NCT00393484 ↗ A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection Completed Bristol-Myers Squibb Phase 4 2007-02-01 Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.
NCT00395018 ↗ Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection Completed Bristol-Myers Squibb Phase 3 2007-04-01 The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Baraclude

Condition Name

Condition Name for Baraclude
Intervention Trials
Chronic Hepatitis B 24
Hepatitis B 17
Hepatitis B, Chronic 12
Hepatitis B Virus 4
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Condition MeSH

Condition MeSH for Baraclude
Intervention Trials
Hepatitis B 68
Hepatitis 64
Hepatitis A 56
Hepatitis B, Chronic 48
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Clinical Trial Locations for Baraclude

Trials by Country

Trials by Country for Baraclude
Location Trials
United States 129
China 60
Japan 35
Brazil 30
Korea, Republic of 26
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Trials by US State

Trials by US State for Baraclude
Location Trials
New York 14
California 13
Texas 10
Florida 10
Illinois 7
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Clinical Trial Progress for Baraclude

Clinical Trial Phase

Clinical Trial Phase for Baraclude
Clinical Trial Phase Trials
Phase 4 25
Phase 3 11
Phase 2 15
[disabled in preview] 14
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Clinical Trial Status

Clinical Trial Status for Baraclude
Clinical Trial Phase Trials
Completed 35
Unknown status 18
Terminated 7
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Clinical Trial Sponsors for Baraclude

Sponsor Name

Sponsor Name for Baraclude
Sponsor Trials
Bristol-Myers Squibb 24
Third Affiliated Hospital, Sun Yat-Sen University 5
Arrowhead Pharmaceuticals 3
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Sponsor Type

Sponsor Type for Baraclude
Sponsor Trials
Other 62
Industry 43
NIH 1
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BARACLUDE: Clinical Trials, Market Analysis, and Projections

Introduction

BARACLUDE, also known as entecavir, is a nucleoside analog used in the treatment of chronic hepatitis B (CHB). It has been a cornerstone in the management of this viral infection, particularly in patients with advanced liver disease. Here, we will delve into the clinical trials that have established its efficacy, the current market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Phase 3 Clinical Trials

BARACLUDE has undergone extensive clinical testing, including several Phase 3 trials. One notable study, ETV-048, compared BARACLUDE (1 mg once daily) to adefovir (10 mg once daily) in CHB patients with decompensated liver disease. The results showed that 57% of patients treated with BARACLUDE achieved an undetectable viral load at 48 weeks, compared to 20% of patients on adefovir[1].

Virologic and Biochemical Outcomes

In these trials, BARACLUDE demonstrated superior virologic suppression and biochemical improvement. For instance, in the ETV-048 study, 61% of BARACLUDE-treated patients showed an improvement or no worsening in the Child-Turcotte-Pugh (CTP) Score, a measure of liver disease severity. Additionally, 5% of BARACLUDE-treated patients lost hepatitis B surface antigen (HBsAg) at Week 48, a significant marker of treatment success[1].

Histologic Improvement

BARACLUDE has also shown histologic improvement in liver inflammation and fibrosis. In studies AI463022 and AI463027, BARACLUDE was superior to lamivudine in achieving histologic improvement, defined as a ≥2-point reduction in the Knodell Necroinflammatory Score with no worsening in the Knodell Fibrosis Score at Week 48[4].

Market Analysis

Global Market Size and Growth

The global hepatitis B drug market, which includes BARACLUDE, is projected to grow significantly. By 2033, the market is expected to reach a value of $2,286 million, exhibiting a Compound Annual Growth Rate (CAGR) of 6% from 2025 to 2033. This growth is driven by the rising prevalence of HBV infections, increasing awareness, and advancements in drug development[2].

Market Segmentation

The market is segmented by application, type, and region. Hospital pharmacies dominate the application segment due to the high demand for specialized treatment services. Entecavir, along with Tenofovir and Lamivudine, leads the types segment as widely prescribed medications for HBV treatment. Key industry players such as Bristol-Myers Squibb, GlaxoSmithKline, and Johnson & Johnson hold significant market shares[2].

Regional Dominance

The Asia-Pacific region is expected to witness the highest growth rate due to a high prevalence of HBV, increasing healthcare expenditure, and government initiatives to improve healthcare infrastructure. This region's growing population and rising disposable incomes further contribute to the market's expansion[2].

Market Projections

Future Growth and Trends

The hepatitis B market is expected to continue growing, driven by several factors:

  • Rising Prevalence: The increasing number of chronic hepatitis B infections globally is a major driver.
  • Advancements in Diagnostics and Therapies: Improved diagnostic tools and antiviral therapies enhance patient outcomes and drive market growth.
  • Combination Therapies: Research into combination treatments involving BARACLUDE and other antiviral agents or immune modulators aims to achieve higher rates of sustained virological response (SVR) and reduce drug resistance[3][5].

Strategic Initiatives

Pharmaceutical companies are focusing on strategic acquisitions, mergers, and partnerships with research institutions to accelerate innovation and market consolidation. These initiatives are expected to further boost the market growth and efficacy of treatments like BARACLUDE[2].

Key Takeaways

  • BARACLUDE has demonstrated significant efficacy in clinical trials, particularly in patients with decompensated liver disease.
  • The global hepatitis B drug market is projected to grow substantially, driven by rising prevalence, advancements in diagnostics and therapies, and increasing healthcare expenditure.
  • The Asia-Pacific region is expected to dominate the market due to high prevalence and growing healthcare infrastructure.
  • Combination therapies and strategic initiatives by pharmaceutical companies are key trends shaping the future of the market.

FAQs

What is BARACLUDE used for?

BARACLUDE (entecavir) is used for the treatment of chronic hepatitis B (CHB) in adult patients, including those with decompensated liver disease.

How effective is BARACLUDE in clinical trials?

BARACLUDE has shown superior virologic suppression and biochemical improvement compared to other antiviral agents like adefovir and lamivudine in clinical trials.

What is the projected growth of the hepatitis B drug market?

The global hepatitis B drug market is expected to reach $2,286 million by 2033, with a CAGR of 6% from 2025 to 2033.

Which region dominates the hepatitis B drug market?

The Asia-Pacific region is expected to dominate the market due to its high prevalence of HBV and increasing healthcare expenditure.

What are the key trends driving the hepatitis B market?

Key trends include the rising prevalence of HBV, advancements in diagnostics and antiviral therapies, development of combination therapies, and strategic initiatives by pharmaceutical companies.

Sources

  1. U.S. Food and Drug Administration Approves BARACLUDE (entecavir) as a Treatment for Chronic Hepatitis B Patients with Evidence of Decompensated Liver Disease. Bristol-Myers Squibb.
  2. Hepatitis B Drug Market's Strategic Roadmap: Insights for 2025-2033. Data Insights Market.
  3. Hepatitis B Market Estimated to Reach USD 4.9 Billion by 2034. BioSpace.
  4. FDA Approves New Treatment Baraclude (entecavir) for Chronic Hepatitis B. NATAP.
  5. Chronic Hepatitis B Market to Reach USD 3,379.3 Million by 2034. BioSpace.

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