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Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT

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: NCT00230477
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : November 15, 2007
Sponsor:
Collaborators:
Gilead Sciences
GlaxoSmithKline
Information provided by:
University of Washington

Study Description
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Brief Summary:

This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic hepatitis B.

The primary hypothesis is that subjects treated with combination therapy will see their viral DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary hypothesis is that subjects treated with combination therapy will have a higher HBeAg conversion rate compared to historical controls of subjects treated with lamivudine or adefovir dipivoxil monotherapy.


Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Hepsera Drug: Hepsera and lamivudine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Adefovir Dipivoxil Versus Adefovir Dipivoxil Plus Lamivudine for the Treatment of Chronic Hepatitis B in Patients With Normal Baseline ALT
Study Start Date : April 2003
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Mono therapy
Hepsera
 Drug: Hepsera
Active Comparator: Combo therapy Drug: Hepsera and lamivudine


Outcome Measures
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Primary Outcome Measures :
  1. Subjects treated with combination therapy will have a decrease in the viral DNA that is greater than the subjects treated with monotherapy. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Subjects treated with combination therapy will have an improved HBeAg conversion rate compared to historical controls treated with either lamivudine or adefovir dipivoxil monotherapy. [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • older than 18 years
  • HBsAg+ at screening and for at least 6 months prior to study entry
  • HBeAg+
  • HBV DNA greater than 6 log10 copies/mL
  • Platelet count greater than 50,000 platelets/mm3
  • Hemoglobin greater than 7.5 g/dL
  • ALT less than ULN
  • Estimated creatine clearance>50 mL/min as estimated by the Crockcroft-Gault equation ((140-age) x (kg)/(serum creatine x 72) (for women x 0.85))
  • Female and male participants must be practicing an effective form of contraception (male or female condom with spermicide, diaphragm or cervical cap with spermicide, intrauterine device, hormonal contraception)
  • Serum alpha-fetoprotein less than 50 ng/mL within 30 days of study entry
  • Childs-Pugh score less than 7 and no ascites, variceal bleeding, or hepatic encephalopathy
  • able to give written informed consent and to comply with the study protocol

Exclusion Criteria:

  • history or evidence of HIV, hepatitis C or hepatitis D
  • known or suspected hypersensitivity to adefovir or other nucleoside/nucleotide analogs.
  • history of clinically significant renal dysfunction
  • any active medical or psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol
  • pregnancy or breastfeeding
  • receipt of systemic corticosteroids within 90 days of study entry
  • receipt of nephrotoxic drugs within 8 weeks prior to study screening or expected use of these agents during the course of the study
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00230477


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Gilead Sciences
GlaxoSmithKline
Investigators
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Principal Investigator: John D Scott, MD, MS University of Washington
More Information
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ClinicalTrials.gov Identifier: NCT00230477    
Other Study ID Numbers: 03-5944-A03
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: November 15, 2007
Last Verified: November 2007
Keywords provided by University of Washington:
Hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
 DNA Virus Infections
Hepatitis, Chronic
Chronic Disease
Disease Attributes
Pathologic Processes
Lamivudine
Adefovir dipivoxil
Adefovir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents