Chronic Hepatitis BPhase 3NCT00857675
A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B
A Phase 3 study testing AAAA, AAPA and PAAA in people with Chronic Hepatitis B, run by GlaxoSmithKline at 10 sites in China.
Trial summary
The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- AAAA, AAPA and PAAA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 10 sitesChina
- Study dates
- Dec 2002to Mar 2008
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening.
- Positive HBV DNA plasma assay with screening value equal or more than 10 (6) copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD less than 300 copies/mL) at the time of screening (within 4 weeks of randomisation).
- Evidence of elevated serum ALT levels defined as serum ALT level greater than or equal to 2.0 times (inclusive) the upper limit of the normal range (ULN) in the previous 6 months, and serum ALT levels greater than 1.0 times the ULN at the time of screening.
Who cannot join
- Evidence of hepatocellular carcinoma;
- Clinical signs of liver decompensation;
- Serum creatinine more than 1.5 mg/dL;
- ALT more than 10 x ULN; seropositivity for hepatitis C or D virus or HIV;
- Lamivudine therapy within 3 months prior to screening;
- ADV therapy or any other anti-HBV therapy within the previous 6 months;
- Use of systemic antiviral agents, immunomodulators, immunosuppressive therapy, Chinese Traditional Medicines or agents known to lower ALT levels during the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
GSK Investigational Site
Beijing, 100011
GSK Investigational Site
Beijing, 100044
GSK Investigational Site
Changchun, Jilin, 130021
GSK Investigational Site
Chongqing, 400038
GSK Investigational Site
Chongquin, 400038
GSK Investigational Site
Guangzhou, Guangdong, 510515
GSK Investigational Site
Guangzhou, Guangdong, 510630
GSK Investigational Site
Hangzhou, Zhejiang, 310003
GSK Investigational Site
Jinan, Shandong
GSK Investigational Site
Shanghai, 200040
About this study
Official title: A Multi-Centre, Double-Blind , Randomized, Placebo-Controlled Phase II/III Study of Adefovir Dipivoxil for the Treatment of Chinese Patients With HBeAg Positive Chronic Hepatitis B Followed by Long-Term (5 Years Total) Adefovir Dipivoxil Treatment. (Report on Year 1 and Year 2 Data)
The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.
- Conditions
- Chronic Hepatitis B
- Being tested
- AAAA, AAPA, PAAA
- Keywords
- HBV DNA suppression, ALT normalisation, Viral resistance, HBeAg seroconversion
- 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.
AAAADrug
Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)
AAPADrug
Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)
PAAADrug
Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Adefovir Dipivoxil | Experimental | ADV 10mg tablets once daily Receives: Drug: AAAA; Drug: AAPA; Drug: PAAA |
| Adefovir Dipivoxil matched placebo | Placebo comparator | Adefovir Dipivoxil matched placebo one tablet once daily Receives: Drug: AAPA; Drug: PAAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo
Measured: Week 12
Secondary outcomes (7)
The proportion of subjects with ALT normalisation
Measured: Week 52, 104, 156, 208, 260
log10 reduction in serum HBV DNA
Measured: Week 52, 104, 156, 208, 260
The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level
Measured: Week 52, 104, 156, 208, 260
The proportion of subjects with HBeAg loss
Measured: Week 52, 104, 156, 208, 260
The proportion of subjects with HBeAg seroconversion
Measured: Week 52, 104, 156, 208, 260
The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance
Measured: Week 52, 104, 156, 208, 260
The proportion of subjects with HBV DNA undetectable (<300 copies/mL)
Measured: Week 52, 104, 156, 208, 260
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startDec 2002
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857675
- Sponsor's protocol ID
- ADF30001
- Status last verified
- Apr 2009
- First submitted
- 5 Mar 2009
- Last updated
- 3 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Double-Blind , Randomized, Placebo-Controlled Phase II/III Study of Adefovir Dipivoxil for the Treatment of Chinese Patients With HBeAg Positive Chronic Hepatitis B Followed by Long-Term (5 Years Total) Adefovir Dipivoxil Treatment. (Report on Year 1 and Year 2 Data)
- ClinicalTrials.gov ID
- NCT00857675
- Acronym / sponsor ID
- ADF30001
- Conditions
- Chronic Hepatitis B
- Keywords
- HBV DNA suppression, ALT normalisation, Viral resistance, HBeAg seroconversion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 9 Mar 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.
The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adefovir Dipivoxil | Experimental | Drug: AAAA, Drug: AAPA, Drug: PAAAADV 10mg tablets once daily |
| Adefovir Dipivoxil matched placebo | Placebo comparator | Drug: AAPA, Drug: PAAAAdefovir Dipivoxil matched placebo one tablet once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65 years
- Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening.
- Positive HBV DNA plasma assay with screening value equal or more than 10 (6) copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD less than 300 copies/mL) at the time of screening (within 4 weeks of randomisation).
- Evidence of elevated serum ALT levels defined as serum ALT level greater than or equal to 2.0 times (inclusive) the upper limit of the normal range (ULN) in the previous 6 months, and serum ALT levels greater than 1.0 times the ULN at the time of screening.
Key exclusion criteria (7 listed)
- Evidence of hepatocellular carcinoma;
- Clinical signs of liver decompensation;
- Serum creatinine more than 1.5 mg/dL;
- ALT more than 10 x ULN; seropositivity for hepatitis C or D virus or HIV;
- Lamivudine therapy within 3 months prior to screening;
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 |
|---|---|---|
| AAAAAdefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks) | Drug | Adefovir Dipivoxil |
| AAPAAdefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks) | Drug | Adefovir Dipivoxil, Adefovir Dipivoxil matched placebo |
| PAAAPlacebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks) | Drug | Adefovir Dipivoxil, Adefovir Dipivoxil matched placebo |
Primary outcome
The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo
Time frame: Week 12
7 secondary outcomes
The proportion of subjects with ALT normalisation
Time frame: Week 52, 104, 156, 208, 260
log10 reduction in serum HBV DNA
Time frame: Week 52, 104, 156, 208, 260
The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level
Time frame: Week 52, 104, 156, 208, 260
The proportion of subjects with HBeAg loss
Time frame: Week 52, 104, 156, 208, 260
The proportion of subjects with HBeAg seroconversion
Time frame: Week 52, 104, 156, 208, 260
The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance
Time frame: Week 52, 104, 156, 208, 260
The proportion of subjects with HBV DNA undetectable (<300 copies/mL)
Time frame: Week 52, 104, 156, 208, 260
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 3 Apr 2009.
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Chronic Hepatitis B
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.
GSK Clinical Trials study director
GlaxoSmithKline
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AAAA, AAPA and PAAA in people with Chronic Hepatitis B, run by GlaxoSmithKline at 10 sites in China.
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 4 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 3 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo (time frame: Week 12). 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 3 Apr 2009.