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CompletedNCT00230477Updated Nov 15, 2007

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

A Phase 4 interventional study of Hepsera and Hepsera and lamivudine in Hepatitis B, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-11-15.

Sponsored by University of Washington · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis B

Keywords

  • Hepatitis B
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 19 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    Mono therapy

    Hepsera

    Drug: Hepsera

  • Active comparator
    Combo therapy

    Drug: Hepsera and lamivudine

Interventions

  • DrugHepsera
  • DrugHepsera and lamivudine
06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Harborview Medical Center
    Seattle, Washington 98104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00230477
Lead sponsor
University of Washington
Collaborators
Gilead Sciences, GlaxoSmithKline
First posted
Sep 30, 2005
Start date
Apr 2003
Completion
Aug 2007
Last update
Nov 15, 2007

Study contacts

John D Scott, MD, MS
principal investigator · University of Washington

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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