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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

September 12, 2005
November 14, 2007
April 2003
Not Provided
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 ]
Subjects treated with combination therapy will have a decrease in the viral DNA that is greater than the subjects treated with monotherapy.
Complete list of historical versions of study NCT00230477 on ClinicalTrials.gov Archive Site
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 ]
Subjects treated with combination therapy will have an improved HBeAg conversion rate compared to historical controls treated with either lamivudine or adefovir dipivoxil monotherapy.
Not Provided
Not Provided
 
Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT
Efficacy of Adefovir Dipivoxil Versus Adefovir Dipivoxil Plus Lamivudine for the Treatment of Chronic Hepatitis B in Patients With Normal Baseline ALT

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B
  • Drug: Hepsera
  • Drug: Hepsera and lamivudine
  • Active Comparator: Mono therapy
    Hepsera
    Intervention: Drug: Hepsera
  • Active Comparator: Combo therapy
    Intervention: Drug: Hepsera and lamivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
August 2007
Not Provided

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00230477
03-5944-A03
No
Not Provided
University of Washington
  • Gilead Sciences
  • GlaxoSmithKline
Principal Investigator: John D Scott, MD, MS University of Washington
University of Washington
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP