Chronic Hepatitis BPhase 4PADDNCT00883844
PEG-IFN in HBV Patients With Incomplete Response to NA
A Phase 4 study testing Nucleos(t)ide analogue treatment with a peginterferon add-on strategy and Nucleos(t)ide analogue treatment in people with Chronic Hepatitis B, run by Foundation for Liver Research at 2 sites in Netherlands.
Trial summary
Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies investigating whether the effect of lowering viral load with nucleoside analogue therapy prior to the initiation of peginterferon results in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Nucleos(t)ide analogue treatment with a peginterferon add-on strategy and Nucleos(t)ide analogue treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesNetherlands
- Study dates
- Apr 2009to Aug 2012
- 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
- Chronic hepatitis B (HBsAg positive > 6 months)
- HBeAg positive, anti-HBe negative within one month prior to initiation of peginterferon alfa-2b
- HBV DNA < 2000 IU/ml during nucleos(t)ide analogue treatment within one month prior to initiation of peginterferon alfa-2b
- Compensated liver disease
- Age > 18 years
- Written informed consent
Who cannot join
- Treatment with any investigational drug within 30 days of entry to this protocol
- Severe hepatitis activity as documented by ALT>10 x ULN
- History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy)
- Pre-existent neutropenia (neutrophils <1,800/mm3) or thrombocytopenia (platelets <90,000/mm3)
- Co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus (HIV)
- Other acquired or inherited causes of liver disease: alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency
Show all 15Show fewer
- Alpha fetoprotein > 50 ng/ml
- Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met)
- Immune suppressive treatment within the previous 6 months
- Contra-indications for alfa-interferon therapy like suspected hypersensitivity to interferon or Peginterferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study.
- Pregnancy, breast-feeding
- Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)
- Any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study
- Substance abuse, such as alcohol (>80 g/day), I.V. drugs and inhaled drugs in the past 2 years.
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
AMC
Amsterdam
Erasmus MC, University Medical Center Rotterdam
Rotterdam
About this study
Official title: Lowering Viral Load With Nucleos(t)Ide Analogues Prior to Peginterferon Alfa-2b Treatment to Increase Sustained Response in HBeAg-positive Chronic Hepatitis B - a Pilot Study
Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies investigating whether the effect of lowering viral load with nucleoside analogue therapy prior to the initiation of peginterferon results in higher sustained off-treatment responses showed contradictory findings.
The aim of this study is to investigate sustained off-treatment response to peginterferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load
- Conditions
- Chronic Hepatitis B
- Being tested
- Nucleos(t)ide analogue treatment with a peginterferon add-on strategy, Nucleos(t)ide analogue treatment
- Keywords
- Hepatitis B, sustained response, peginterferon, nucleos(t)ide analogues
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleos(t)ide analogue treatment with a peginterferon add-on strategyDrug
peginterferon 1.5 microgram/kg once a week Treatment with one of the approved nucleos(t)ide analogues
Nucleos(t)ide analogue treatmentDrug
Treatment with one of the approved nucleos(t)ide analogues
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Continuation of any Nucleos(t)ide analogue treatment and add-on of peginterferon for 24 weeks Receives: Drug: Nucleos(t)ide analogue treatment with a peginterferon add-on strategy |
| 2 | Active comparator | Continuation of Nucleos(t)ide analogue mono-therapy Receives: Drug: Nucleos(t)ide analogue treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained response defined as HBeAg loss and HBV DNA level < 200 IU/mL
Measured: at week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry LA Janssen, MD PhD, Principal investigator, Erasmus MC, University Medical Center Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883844
- Sponsor's protocol ID
- HBV09-03
- Acronym
- PADD
- Status last verified
- Apr 2013
- First submitted
- 17 Apr 2009
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lowering Viral Load With Nucleos(t)Ide Analogues Prior to Peginterferon Alfa-2b Treatment to Increase Sustained Response in HBeAg-positive Chronic Hepatitis B - a Pilot Study
- ClinicalTrials.gov ID
- NCT00883844
- Acronym / sponsor ID
- PADD / HBV09-03
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B, sustained response, peginterferon, nucleos(t)ide analogues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Apr 2009 (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.
Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies investigating whether the effect of lowering viral load with nucleoside analogue therapy prior to the initiation of peginterferon results in higher sustained off-treatment responses showed contradictory findings.
The aim of this study is to investigate sustained off-treatment response to peginterferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nucleos(t)ide analogue treatment with a peginterferon add-on strategyContinuation of any Nucleos(t)ide analogue treatment and add-on of peginterferon for 24 weeks |
| 2 | Active comparator | Drug: Nucleos(t)ide analogue treatmentContinuation of Nucleos(t)ide analogue mono-therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic hepatitis B (HBsAg positive > 6 months)
- HBeAg positive, anti-HBe negative within one month prior to initiation of peginterferon alfa-2b
- HBV DNA < 2000 IU/ml during nucleos(t)ide analogue treatment within one month prior to initiation of peginterferon alfa-2b
- Compensated liver disease
- Age > 18 years
Key exclusion criteria (15 listed)
- Treatment with any investigational drug within 30 days of entry to this protocol
- Severe hepatitis activity as documented by ALT>10 x ULN
- History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy)
- Pre-existent neutropenia (neutrophils <1,800/mm3) or thrombocytopenia (platelets <90,000/mm3)
- Co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus (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 |
|---|---|---|
| Nucleos(t)ide analogue treatment with a peginterferon add-on strategypeginterferon 1.5 microgram/kg once a week Treatment with one of the approved nucleos(t)ide analogues | Drug | 1 |
| Nucleos(t)ide analogue treatmentTreatment with one of the approved nucleos(t)ide analogues | Drug | 2 |
Primary outcome
Sustained response defined as HBeAg loss and HBV DNA level < 200 IU/mL
Time frame: at week 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 19 Apr 2013.
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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.
Harry LA Janssen, MD PhD principal investigator
Erasmus MC, University Medical Center Rotterdam
2 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 Nucleos(t)ide analogue treatment with a peginterferon add-on strategy and Nucleos(t)ide analogue treatment in people with Chronic Hepatitis B, run by Foundation for Liver Research at 2 sites in Netherlands.
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 6 inclusion and 15 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 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Sustained response defined as HBeAg loss and HBV DNA level < 200 IU/mL (time frame: at 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 19 Apr 2013.