Hepatitis BPhase 4NCT00230477
Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT
A Phase 4 study testing Hepsera and Hepsera and lamivudine in people with Hepatitis B, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Hepsera and Hepsera and lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Aug 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: 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.
- Conditions
- Hepatitis B
- Being tested
- Hepsera, Hepsera and lamivudine
- Keywords
- Hepatitis B
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepseraDrug
Hepsera and lamivudineDrug
| Study group | Role | What they receive |
|---|---|---|
| Mono therapy | Active comparator | Hepsera Receives: Drug: Hepsera |
| Combo therapy | Active comparator | Not described Receives: Drug: Hepsera and lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects treated with combination therapy will have a decrease in the viral DNA that is greater than the subjects treated with monotherapy.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startApr 2003
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, GlaxoSmithKline
- Investigators
- John D Scott, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230477
- Sponsor's protocol ID
- 03-5944-A03
- Status last verified
- Nov 2007
- First submitted
- 12 Sep 2005
- Last updated
- 15 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adefovir Dipivoxil Versus Adefovir Dipivoxil Plus Lamivudine for the Treatment of Chronic Hepatitis B in Patients With Normal Baseline ALT
- ClinicalTrials.gov ID
- NCT00230477
- Acronym / sponsor ID
- 03-5944-A03
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Gilead Sciences, GlaxoSmithKline
- Study start
- Apr 2003
- Study completion
- Aug 2007 (actual)
- First posted
- 30 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mono therapy | Active comparator | Drug: HepseraHepsera |
| Combo therapy | Active comparator | Drug: Hepsera and lamivudine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepsera | Drug | Mono therapy |
| Hepsera and lamivudine | Drug | Combo therapy |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Scott, MD, MS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hepsera and Hepsera and lamivudine in people with Hepatitis B, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2007.