Hepatitis B, ChronicNCT01283074
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HbeAg-negative Chronic Hepatitis B (Perseas)
An observational study of Hepatitis B, Chronic, run by Hoffmann-La Roche at 16 sites in Greece.
Trial summary
This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 107 participants
- Where
- 16 sitesGreece
- Study dates
- May 2009to Nov 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis B on treatment with Pegasys
Who may be able to join
- Adult patients, >/=18 years of age
- Diagnosis of HBeAg-negative chronic hepatitis B with compensated hepatic disease, virus multiplication, raised alanine amino transferase results and/or fibrosis
Who cannot join
- Co-infection with hepatitis A, C or D
- Co-infection with human immunodeficiency virus (HIV)
- Severe hepatic dysfunction or decompensated liver disease
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Greece16 sites
Study site
Alexandroupoli, 68100
Study site
Athens, 10676
Study site
Athens, 115 27
Study site
Athens, 11521
Study site
Athens, 11527
Study site
Athens, 11528
Study site
Athens, 124 61
Study site
Larissa, 41 110
Study site
Pátrai, 265 04
Study site
Piraeus, 18454
Study site
Piraeus, 18536
Study site
Rhodes, 85100
Study site
Thessaloniki, 546 42
Study site
Thessaloniki, 54636
Study site
Thessaloniki, 56429
Study site
Thessaloniki, 57010
About this study
Official title: Prognostic Factors of Long-term Response to Treatment With Pegylated Interferon Alfa-2a in Patients With HbeAg-negative Chronic Hepatitis B. (Perseas)
This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.
- Conditions
- Hepatitis B, Chronic
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with combined (virological and biochemical) response
Measured: 48 weeks after end of treatment
Secondary outcomes (2)
Normalization of serum alanine aminotransferase
Measured: 12 months
Safety (Incidence of adverse events)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startMay 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 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
- NCT01283074
- Sponsor's protocol ID
- ML22016
- Status last verified
- Nov 2016
- First submitted
- 24 Jan 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Goulis I, Karatapanis S, Akriviadis E, Deutsch M, Dalekos GN, Raptopoulou-Gigi M, Mimidis K, Germanidis G, Drakoulis C, Triantos C, Zintzaras E, Bakalos G, Papatheodoridis G. On-treatment prediction of sustained response to peginterferon alfa-2a for HBeAg-negative chronic hepatitis B patients. Liver Int. 2015 May;35(5):1540-8. doi: 10.1111/liv.12725. Epub 2014 Nov 20.
PubMed 25368957
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
- Prognostic Factors of Long-term Response to Treatment With Pegylated Interferon Alfa-2a in Patients With HbeAg-negative Chronic Hepatitis B. (Perseas)
- ClinicalTrials.gov ID
- NCT01283074
- Acronym / sponsor ID
- ML22016
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Jan 2011 (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 observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis B on treatment with Pegasys
Key inclusion criteria (2 listed)
- Adult patients, >/=18 years of age
- Diagnosis of HBeAg-negative chronic hepatitis B with compensated hepatic disease, virus multiplication, raised alanine amino transferase results and/or fibrosis
Key exclusion criteria (3 listed)
- Co-infection with hepatitis A, C or D
- Co-infection with human immunodeficiency virus (HIV)
- Severe hepatic dysfunction or decompensated 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.
Primary outcome
Percentage of patients with combined (virological and biochemical) response
Time frame: 48 weeks after end of treatment
2 secondary outcomes
Normalization of serum alanine aminotransferase
Time frame: 12 months
Safety (Incidence of adverse events)
Time frame: 12 months
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.
- Derived from this study: PubMed 25368957Goulis I, Karatapanis S, Akriviadis E, Deutsch M, Dalekos GN, Raptopoulou-Gigi M, Mimidis K, Germanidis G, Drakoulis C, Triantos C, Zintzaras E, Bakalos G, Papatheodoridis G. On-treatment prediction of sustained response to peginterferon alfa-2a for HBeAg-negative chronic hepatitis B patients. Liver Int. 2015 May;35(5):1540-8. doi: 10.1111/liv.12725. Epub 2014 Nov 20.
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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
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Hoffmann-La Roche at 16 sites in Greece.
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 2 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 16 sites in Greece. 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.
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?
Percentage of patients with combined (virological and biochemical) response (time frame: 48 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01283074, which also lists 1 linked publication.
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.