Hepatitis B, ChronicPhase 4NCT00922207
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
A Phase 4 study testing Adefovir, Entecavir and peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 9 sites in Taiwan.
Trial summary
This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly… 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, Entecavir and peginterferon alfa-2a [Pegasys]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 9 sitesTaiwan
- Study dates
- 7 May 2010to 29 Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 patients, 18-65 years of age;
- HBeAg+ve for >=3 months;
- positive serum HBV DNA within 3 months prior to entry;
- patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
- >=3 months treatment-free interval from nucleotide analogues.
Who cannot join
- evidence of decompensated liver disease;
- history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
- co-infection with active hepatitis A,C or D, or HIV.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Taiwan9 sites
Changhua Christian Hospital; Internal Medicine
Changhua, 500
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
Kaohsiung City, 00833
Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
Kaohsiung City, 807
Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
Keelung, 204
China Medical University Hospital; Department of Rheumatology
Taichung, 404
National Taiwan Uni Hospital; Gastro-Enterology Dept.
Taipei, 100
Taipei Veterans General Hospital; Gastroenterology Division
Taipei, 112
Tri-Service Hospital; Dept. of Internal Medicine
Taipei
Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
Taoyuan, 333
About this study
Official title: A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B
This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Adefovir, Entecavir, Placebo, 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.
AdefovirDrug
From week -4 to week 2
EntecavirDrug
From week -4 to week 2
PlaceboDrug
From week -4 to week 2
peginterferon alfa-2a [Pegasys]Drug
180 micrograms sc weekly, from week 1-48
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Adefovir; Drug: peginterferon alfa-2a [Pegasys] |
| 2 | Experimental | Not described Receives: Drug: Entecavir; Drug: peginterferon alfa-2a [Pegasys] |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo; Drug: peginterferon alfa-2a [Pegasys] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).
Measured: Week 100
Secondary outcomes (6)
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.
Measured: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participants Who Were HBeAg Negative
Measured: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Measured: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
The normal range for ALT is 10 to 40 international units per liter (IU/L).
Measured: Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Measured: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participants With Combined Response
Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).
Measured: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study start7 May 2010
- Primary completion29 Sep 2014
- Study completion29 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 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
- NCT00922207
- Sponsor's protocol ID
- ML21827
- Status last verified
- Mar 2017
- First submitted
- 16 Jun 2009
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00922207
- Acronym / sponsor ID
- ML21827
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 7 May 2010 (actual)
- Primary completion
- 29 Sep 2014 (actual)
- Study completion
- 29 Sep 2014 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Posted 20 Nov 2015
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 assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Adefovir, Drug: peginterferon alfa-2a [Pegasys] |
| 2 | Experimental | Drug: Entecavir, Drug: peginterferon alfa-2a [Pegasys] |
| 3 | Placebo comparator | Drug: Placebo, Drug: peginterferon alfa-2a [Pegasys] |
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 patients, 18-65 years of age;
- HBeAg+ve for >=3 months;
- positive serum HBV DNA within 3 months prior to entry;
- patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
- >=3 months treatment-free interval from nucleotide analogues.
Key exclusion criteria (3 listed)
- evidence of decompensated liver disease;
- history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
- co-infection with active hepatitis A,C or D, or HIV.
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 |
|---|---|---|
| AdefovirFrom week -4 to week 2 | Drug | 1 |
| EntecavirFrom week -4 to week 2 | Drug | 2 |
| PlaceboFrom week -4 to week 2 | Drug | 3 |
| peginterferon alfa-2a [Pegasys]180 micrograms sc weekly, from week 1-48 | Drug | 1, 2, 3 |
Primary outcome
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment
Time frame: Week 100
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).
6 secondary outcomes
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participants Who Were HBeAg Negative
Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Time frame: Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participants With Combined Response
Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adefovir, Entecavir and peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 9 sites in Taiwan.
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: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan. 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 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?
Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment (time frame: Week 100). 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 10 Apr 2017.