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

This study has been completed.
Sponsor:
Collaborators:
Gilead Sciences
GlaxoSmithKline
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00230477
First received: September 12, 2005
Last updated: November 14, 2007
Last verified: November 2007
History of Changes
  Purpose

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 Intervention Phase
Hepatitis B
 Drug: Hepsera
Drug: Hepsera and lamivudine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 19
Study Start Date: April 2003
Study Completion Date: August 2007
Arms Assigned Interventions
Active Comparator: Mono therapy
Hepsera
 Drug: Hepsera
Active Comparator: Combo therapy Drug: Hepsera and lamivudine

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230477

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Gilead Sciences
GlaxoSmithKline
Investigators
Principal Investigator: John D Scott, MD, MS University of Washington
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00230477     History of Changes
Other Study ID Numbers: 03-5944-A03
Study First Received: September 12, 2005
Last Updated: November 14, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
 Adefovir dipivoxil
Adefovir
Lamivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 18, 2013