Hepatitis B, ChronicPhase 4NCT00986778
Entecavir Plus Adefovir in Lamivudine-Resistant Patients
A Phase 4 study testing Lamivudine, Entecavir and Adefovir in people with Hepatitis B, Chronic, run by Bristol-Myers Squibb.
Trial summary
Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Lamivudine, Entecavir and Adefovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Jun 2014
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I
- Naïve to nucleoside/nucleotide analogues except for LVD
- HBV DNA > 17,200 IU/mL
- Compensated liver function
- Serum ALT <10 × ULN
Who cannot join
- Women who are pregnant or breastfeeding
- Evidence of decompensated cirrhosis
- Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
About this study
Official title: A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Chinese Subjects
Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection
- Conditions
- Hepatitis B, Chronic
- Being tested
- Lamivudine, Entecavir, Adefovir
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamivudineDrug
Also called Heptotin
Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response
EntecavirDrug
Also called Baraclude
Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response
AdefovirDrug
Also called Hepsera
Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response
| Study group | Role | What they receive |
|---|---|---|
| Lamivudine plus Adefovir | Active comparator | Not described Receives: Drug: Lamivudine; Drug: Adefovir |
| Entecavir | Active comparator | Not described Receives: Drug: Entecavir |
| Entecavir plus Adefovir | Experimental | Not described Receives: Drug: Entecavir; Drug: Adefovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with HBV DNA < 50 IU/mL at W48
Measured: Week 48
Secondary outcomes (6)
The proportion of patient with HBV DNA < 50 IU/mL at W 96
Measured: Week 96
Mean reduction of HBV DNA at W 48 & 96
Measured: Week 48 and 96
The proportion of subjects with ALT normalization at W 48 & 96
Measured: Week 48 & Week 96
The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96
Measured: Week 48 & 96
Safety
Measured: Week 48 and Week 96
Resistance
Measured: Week 48 & Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2012 (estimated)
- Study completionJun 2014 (estimated)
Why it stopped: Business Objectives Changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986778
- Sponsor's protocol ID
- AI463-195
- Status last verified
- Dec 2009
- First submitted
- 29 Sep 2009
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Chinese Subjects
- ClinicalTrials.gov ID
- NCT00986778
- Acronym / sponsor ID
- AI463-195
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Objectives Changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 30 Sep 2009 (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.
Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lamivudine plus Adefovir | Active comparator | Drug: Lamivudine, Drug: Adefovir |
| Entecavir | Active comparator | Drug: Entecavir |
| Entecavir plus Adefovir | Experimental | Drug: Entecavir, Drug: Adefovir |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I
- Naïve to nucleoside/nucleotide analogues except for LVD
- HBV DNA > 17,200 IU/mL
- Compensated liver function
- Serum ALT <10 × ULN
Key exclusion criteria (3 listed)
- Women who are pregnant or breastfeeding
- Evidence of decompensated cirrhosis
- Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
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 |
|---|---|---|
| LamivudineAlso: HeptotinTablets, Oral, 100mg, once daily, 48-96 weeks depending on response | Drug | Lamivudine plus Adefovir |
| EntecavirAlso: BaracludeTablets, Oral, 1mg, once daily, 48-96 weeks depending on response | Drug | Entecavir, Entecavir plus Adefovir |
| AdefovirAlso: HepseraTablets, Oral, 10mg, once daily, 48-96 weeks depending on response | Drug | Entecavir plus Adefovir, Lamivudine plus Adefovir |
Primary outcome
The proportion of patients with HBV DNA < 50 IU/mL at W48
Time frame: Week 48
6 secondary outcomes
The proportion of patient with HBV DNA < 50 IU/mL at W 96
Time frame: Week 96
Mean reduction of HBV DNA at W 48 & 96
Time frame: Week 48 and 96
The proportion of subjects with ALT normalization at W 48 & 96
Time frame: Week 48 & Week 96
The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96
Time frame: Week 48 & 96
Safety
Time frame: Week 48 and Week 96
Resistance
Time frame: Week 48 & Week 96
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lamivudine, Entecavir and Adefovir in people with Hepatitis B, Chronic, run by Bristol-Myers Squibb.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The proportion of patients with HBV DNA < 50 IU/mL at W48 (time frame: Week 48). 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 1 Sep 2015.