Hepatitis B, ChronicPhase 3NCT00661076
ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
A Phase 3 study testing adefovir dipivoxil and peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 5 sites in Turkey (Türkiye).
Trial summary
This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- adefovir dipivoxil and peginterferon alfa-2a [Pegasys]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- Aug 2008to May 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-70 years of age;
- chronic hepatitis B;
- positive HBsAg, positive anti-HBe, negative anti HBsAg, negative HBeAg for at least the prior 6 months;
- either nucleoside analogue naive, or has not received IFN-a in the past 6 months.
Who cannot join
- positive for hepatitis A, C, D or HIV;
- history or other evidence of a medical condition associated with chronic liver disease other than hepatitis B;
- antiviral, antineoplastic or immunomodulatory treatment <=6 months prior to first dose of randomized treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Turkey (Türkiye)5 sites
Study site
Ankara, 06018
Study site
Ankara, 06100
Study site
Ankara, 06500
Study site
Ankara, 06800
Study site
Gaziantep, 27310
About this study
Official title: A Randomized, Open Label Study to Compare the Effect of Combination Treatment With PEGASYS + Adefovir Dipivoxil Versus PEGASYS Monotherapy on HBV-DNA and ALT Levels in Patients With HBeAg-negative, Chronic Hepatitis B.'
This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
- Conditions
- Hepatitis B, Chronic
- Being tested
- adefovir dipivoxil, peginterferon alfa-2a [Pegasys]
- 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.
adefovir dipivoxilDrug
10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)
peginterferon alfa-2a [Pegasys]Drug
180 micrograms weekly for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: adefovir dipivoxil; Drug: peginterferon alfa-2a [Pegasys] |
| 2 | Experimental | Not described Receives: Drug: adefovir dipivoxil; Drug: peginterferon alfa-2a [Pegasys] |
| 3 | Active comparator | Not described Receives: Drug: peginterferon alfa-2a [Pegasys] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of ALT, and HBV-DNA <400 copies/mL
Measured: Week 96 for arm 1; week 48 for arms 2 and 3
HBsAg quantitative loss and anti-HBs seroconversion
Measured: Weeks 48, 96 and 144
Secondary outcomes (1)
AEs, lab parameters, vital signs
Measured: Throughtout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2011
- Study completionMay 2011
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 Hoffmann-La RocheThe 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
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661076
- Sponsor's protocol ID
- ML20622
- Status last verified
- Nov 2016
- First submitted
- 16 Apr 2008
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Study to Compare the Effect of Combination Treatment With PEGASYS + Adefovir Dipivoxil Versus PEGASYS Monotherapy on HBV-DNA and ALT Levels in Patients With HBeAg-negative, Chronic Hepatitis B.'
- ClinicalTrials.gov ID
- NCT00661076
- Acronym / sponsor ID
- ML20622
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Apr 2008 (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 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: adefovir dipivoxil, Drug: peginterferon alfa-2a [Pegasys] |
| 2 | Experimental | Drug: adefovir dipivoxil, Drug: peginterferon alfa-2a [Pegasys] |
| 3 | Active comparator | Drug: peginterferon alfa-2a [Pegasys] |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, 18-70 years of age;
- chronic hepatitis B;
- positive HBsAg, positive anti-HBe, negative anti HBsAg, negative HBeAg for at least the prior 6 months;
- either nucleoside analogue naive, or has not received IFN-a in the past 6 months.
Key exclusion criteria (3 listed)
- positive for hepatitis A, C, D or HIV;
- history or other evidence of a medical condition associated with chronic liver disease other than hepatitis B;
- antiviral, antineoplastic or immunomodulatory treatment <=6 months prior to first dose of randomized treatment.
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 |
|---|---|---|
| adefovir dipivoxil10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2) | Drug | 1, 2 |
| peginterferon alfa-2a [Pegasys]180 micrograms weekly for 48 weeks | Drug | 1, 2, 3 |
Primary outcome
Normalization of ALT, and HBV-DNA <400 copies/mL
Time frame: Week 96 for arm 1; week 48 for arms 2 and 3
HBsAg quantitative loss and anti-HBs seroconversion
Time frame: Weeks 48, 96 and 144
1 secondary outcome
AEs, lab parameters, vital signs
Time frame: Throughtout study
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 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
5 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 adefovir dipivoxil and peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 5 sites in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). 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 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?
Normalization of ALT, and HBV-DNA <400 copies/mL (time frame: Week 96 for arm 1; week 48 for arms 2 and 3). The study lists 2 primary outcomes in all. 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 2 Nov 2016.