Hepatitis B, ChronicNCT01794234
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
An observational study of Hepatitis B, Chronic, run by Hoffmann-La Roche at 9 sites in Poland.
Trial summary
This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. 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
- 44 participants
- Where
- 9 sitesPoland
- Study dates
- Aug 2012to Sep 2013
- 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 initiated on therapy with Pegasys
Who may be able to join
- Adult patients, >/= 18 years of age
- Positive HBsAg for more than 6 months before assignment to treatment with Pegasys
- Detectable HBV DNA (as measured by PCR)
- HBeAg positive and negative patients
- Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard
- Elevated serum alanine aminotransferase (ALT)
- Chronic hepatitis B confirmed by liver biopsy or non-invasive assessment (FibroScan), ARFI, FibroTest) or by clinical evaluation
Who cannot join
- Contraindications to treatment with Pegasys according to the Summary of Product Characteristics
- Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver
- Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment
- Planned other than Pegasys antiviral treatment during Pegasys therapy
- Chronic liver disease other than chronic hepatitis B
- Pregnant or breast-feeding women
Show all 9Show fewer
- Inadequate hematologic function
- Autoimmunology disorders
- Co-infection with chronic hepatitis C or HIV
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Poland9 sites
Study site
Bytom, 41-902
Study site
Dębica, 39-200
Study site
Gdansk, 80-214
Study site
Krakow, 31-202
Study site
Krakow, 31-501
Study site
Łańcut, 37-100
Study site
Mysłowice, 41-400
Study site
Racibórz, 47-400
Study site
Wroclaw, 51-149
About this study
Official title: Efficacy and Safety of Peginterferon Alfa-2a (40 KD) in Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment With Nucleoside (Nucleotide) Analogues - an Observational Study in Real-life Clinical Practice
This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.
- 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.
Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)
Measured: approximately 2.5 years
Secondary outcomes (4)
HBs levels in correlation with treatment outcome
Measured: approximately 2.5 years
For HBeAg positive patients: Proportion of patients with HBeAg loss and presence of anti HBe (HBeAg seroconversion) at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)
Measured: approximately 2.5 years
For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization
Measured: approximately 2.5 years
Safety: Incidence of adverse events
Measured: approximately 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionSep 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 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
- NCT01794234
- Sponsor's protocol ID
- ML28346
- Status last verified
- Nov 2016
- First submitted
- 15 Feb 2013
- 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
- Efficacy and Safety of Peginterferon Alfa-2a (40 KD) in Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment With Nucleoside (Nucleotide) Analogues - an Observational Study in Real-life Clinical Practice
- ClinicalTrials.gov ID
- NCT01794234
- Acronym / sponsor ID
- ML28346
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Feb 2013 (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 study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.
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 initiated on therapy with Pegasys
Key inclusion criteria (7 listed)
- Adult patients, >/= 18 years of age
- Positive HBsAg for more than 6 months before assignment to treatment with Pegasys
- Detectable HBV DNA (as measured by PCR)
- HBeAg positive and negative patients
- Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard
Key exclusion criteria (9 listed)
- Contraindications to treatment with Pegasys according to the Summary of Product Characteristics
- Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver
- Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment
- Planned other than Pegasys antiviral treatment during Pegasys therapy
- Chronic liver disease other than chronic hepatitis B
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
Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)
Time frame: approximately 2.5 years
4 secondary outcomes
HBs levels in correlation with treatment outcome
Time frame: approximately 2.5 years
For HBeAg positive patients: Proportion of patients with HBeAg loss and presence of anti HBe (HBeAg seroconversion) at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)
Time frame: approximately 2.5 years
For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization
Time frame: approximately 2.5 years
Safety: Incidence of adverse events
Time frame: approximately 2.5 years
Results and safety
The study was stopped early. Results are not available in the source record.
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
9 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 9 sites in Poland.
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 7 inclusion and 9 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 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 9 sites in Poland. 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 was stopped early. 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?
Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up) (time frame: approximately 2.5 years). 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.