Hepatitis B, ChronicPhase 4NCT02598063
A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B
A Phase 4 study testing Adefovir dipivoxil, Lamivudine and Peginterferon alfa-2a in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 12 sites in 2 countries.
Trial summary
This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Adefovir dipivoxil, Lamivudine and Peginterferon alfa-2a
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Oct 2005to Apr 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants 18-65 years of age
- Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (>=) 6 months
- Receiving lamivudine currently, and for >=6 months
- hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased >=2 log during lamivudine treatment on >=1 occasion
- Absence of cirrhosis confirmed by liver biopsy in previous 6 months
Who cannot join
- Other drugs with activity against HBV within the prior 6 months, except lamivudine
- Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus
- Decompensated liver disease
- Medical condition associated with another chronic liver disease
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
China10 sites
Study site
Beijing, 100044
Study site
Beijing, 100050
Study site
Beijing, 100054
Study site
Chongqing, 400038
Study site
Guangzhou, 510515
Study site
Hangzhou, 310003
Study site
Jinan, 250021
Study site
Shanghai, 200025
Study site
Shanghai, 200040
Study site
Shanghai, 201508
About this study
Official title: A Randomized, Open-label Study Evaluating the Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) or Adefovir Dipivoxil (ADV) in Patients With Lamivudine-resistant HBeAg Positive Chronic Hepatitis B
This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Adefovir dipivoxil, Lamivudine, Peginterferon alfa-2a
- 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
ADV will be administered orally at a dose of 10 mg QD for 72 weeks.
LamivudineDrug
Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.
Peginterferon alfa-2aDrug
Also called Pegasys
Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ADV + Lamivudine | Active comparator | Participants will receive ADV and lamivudine tablets at a dose of 10 mg orally QD for first 12 weeks followed by ADV for 60 weeks. Receives: Drug: Adefovir dipivoxil; Drug: Lamivudine |
| Peginterferon alfa-2a + Lamivudine | Experimental | Participants will receive peginterferon alfa-2a injection at a dose of 180 micrograms (mcg) once weekly (QW) and 100 milligrams (mg) lamivudine tablets orally once daily (QD) for first 12 weeks followed by peginterferon alfa-2a for 36 weeks. Receives: Drug: Lamivudine; Drug: Peginterferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72
Measured: Week 72
Secondary outcomes (4)
Loss of HBeAg
Measured: Week 48, and 72
Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)
Measured: Week 48, and 72
Alanine transaminase (ALT) normalization
Measured: Week 48, and 72
Hepatitis B surface antigen (HBsAg) seroconversion
Measured: Week 48, and 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startOct 2005
- Primary completionApr 2009
- Study completionApr 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598063
- Sponsor's protocol ID
- ML18376
- Status last verified
- Feb 2016
- First submitted
- 4 Nov 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study Evaluating the Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) or Adefovir Dipivoxil (ADV) in Patients With Lamivudine-resistant HBeAg Positive Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT02598063
- Acronym / sponsor ID
- ML18376
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Nov 2015 (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 study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADV + Lamivudine | Active comparator | Drug: Adefovir dipivoxil, Drug: LamivudineParticipants will receive ADV and lamivudine tablets at a dose of 10 mg orally QD for first 12 weeks followed by ADV for 60 weeks. |
| Peginterferon alfa-2a + Lamivudine | Experimental | Drug: Lamivudine, Drug: Peginterferon alfa-2aParticipants will receive peginterferon alfa-2a injection at a dose of 180 micrograms (mcg) once weekly (QW) and 100 milligrams (mg) lamivudine tablets orally once daily (QD) for first 12 weeks followed by peginterferon alfa-2a for 36 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult participants 18-65 years of age
- Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (>=) 6 months
- Receiving lamivudine currently, and for >=6 months
- hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased >=2 log during lamivudine treatment on >=1 occasion
- Absence of cirrhosis confirmed by liver biopsy in previous 6 months
Key exclusion criteria (4 listed)
- Other drugs with activity against HBV within the prior 6 months, except lamivudine
- Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus
- Decompensated liver disease
- Medical condition associated with another chronic liver disease
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 dipivoxilADV will be administered orally at a dose of 10 mg QD for 72 weeks. | Drug | ADV + Lamivudine |
| LamivudineLamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks. | Drug | ADV + Lamivudine, Peginterferon alfa-2a + Lamivudine |
| Peginterferon alfa-2aAlso: PegasysPeginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks. | Drug | Peginterferon alfa-2a + Lamivudine |
Primary outcome
HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72
Time frame: Week 72
4 secondary outcomes
Loss of HBeAg
Time frame: Week 48, and 72
Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)
Time frame: Week 48, and 72
Alanine transaminase (ALT) normalization
Time frame: Week 48, and 72
Hepatitis B surface antigen (HBsAg) seroconversion
Time frame: Week 48, and 72
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 Feb 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 chair
Hoffmann-La Roche
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adefovir dipivoxil, Lamivudine and Peginterferon alfa-2a in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 12 sites in 2 countries.
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 4 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China, Hong Kong. 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?
HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72 (time frame: Week 72). 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 Feb 2016.