Hepatitis B, ChronicPhase 4NCT00460850
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
A Phase 4 study testing peginterferon alfa-2a (40KD) [PEGASYS] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 4 sites in Turkey (Türkiye).
Trial summary
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. 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?
- peginterferon alfa-2a (40KD) [PEGASYS]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- Sep 2007to Jun 2008
- 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 patients, 18-65 years of age;
- HBeAg negative chronic hepatitis B;
- treated with lamivudine for >=6 months;
- demonstrated lamivudine resistance;
- compensated liver disease.
Who cannot join
- severe hepatic dysfunction;
- previous treatment with antivirals other than lamivudine;
- immunosuppressant treatment in past 6 months;
- co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
- medical condition associated with chronic liver disease.
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Study site
Ankara, 06620
Study site
Antalya, 07058
Study site
Istanbul, 34390
Study site
Izmir, 35360
About this study
Official title: An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
- Conditions
- Hepatitis B, Chronic
- Being tested
- peginterferon alfa-2a (40KD) [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.
peginterferon alfa-2a (40KD) [PEGASYS]Drug
180 micrograms sc weekly for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: peginterferon alfa-2a (40KD) [PEGASYS] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Measured: Week 96
Secondary outcomes (3)
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Measured: Weeks 48 and 72
HBsAg loss and anti-HBs seroconversion
Measured: Weeks 48, 72 and 96
AEs and lab parameters
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startSep 2007
- Study completionJun 2008
Why it stopped: Low recruitment rate due to treatment regimen change
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460850
- Sponsor's protocol ID
- ML20135
- Status last verified
- Jun 2008
- First submitted
- 16 Apr 2007
- Last updated
- 30 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00460850
- Acronym / sponsor ID
- ML20135
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate due to treatment regimen change
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Apr 2007 (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 single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: peginterferon alfa-2a (40KD) [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 negative chronic hepatitis B;
- treated with lamivudine for >=6 months;
- demonstrated lamivudine resistance;
- compensated liver disease.
Key exclusion criteria (5 listed)
- severe hepatic dysfunction;
- previous treatment with antivirals other than lamivudine;
- immunosuppressant treatment in past 6 months;
- co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
- medical condition associated with 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 |
|---|---|---|
| peginterferon alfa-2a (40KD) [PEGASYS]180 micrograms sc weekly for 48 weeks | Drug | 1 |
Primary outcome
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Time frame: Week 96
3 secondary outcomes
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Time frame: Weeks 48 and 72
HBsAg loss and anti-HBs seroconversion
Time frame: Weeks 48, 72 and 96
AEs and lab parameters
Time frame: Throughout study
Results and safety
The study was stopped early (reason given: Low recruitment rate due to treatment regimen change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2008.
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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
4 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 peginterferon alfa-2a (40KD) [PEGASYS] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 4 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 30 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 stopped early (reason given: Low recruitment rate due to treatment regimen change). Results are not available in the source record.
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 <10,000 copies/mL (time frame: Week 96). 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 30 Jun 2008.