Chronic Hepatitis BPhase 3PEGANNCT01172392
A Randomized Study to Assess the Loss of HbsAg After a 48-week Treatment Period With Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B
A Phase 3 study testing Pegylated interferon-alpha-2a and Nucleotidic or Nucleosidic Treatment in people with Chronic Hepatitis B and AgHbs Negativation, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
The purpose of this study is to assess the loss of HbsAg after a 48-week pegylated interferon alpha 2a in patients with chronic hepatitis B (HBeAg negativation) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis B, AgHbs Negativation
- What is being tested?
- Pegylated interferon-alpha-2a and Nucleotidic or Nucleosidic Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Jun 2015
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive Hbs Ag
- Negative HbeAg
- Plasma HBV DNA undetectable at pre-inclusion ever since 12 months
- ALT less than or equal to 5 times the upper limit of normal
- Non cirrhotic or Not Decompensated Cirrhosis (Child Pugh <7)
- Undetectable hepatocellular carcinoma in liver scan and / or alpha-fetoprotein rate <50 ng / ml
Show all 10Show fewer
- Unchanged nucleoside (s) and / or nucleotide (s) treatment for at least three months (and not including telbivudine)
- Negative pregnancy test for childbearing women
- Signed informed consent
- Use of contraception for childbearing women
Who cannot join
- Polymorphonuclear neutrophils <1500/mm3
- Platelets <70.000/mm3
- Co-infections with HIV, HCV and / or HDV
- Prolonged excessive consumption of alcohol
- Active intravenous drug addiction
- Immunomodulators Treatment(eg interferons), ever since one year
Show all 20Show fewer
- Immunosuppressive treatments terminated ever since one year
- Telbivudine treatment
- Long course steroid treatment (more than 4 weeks) by oral way
- History of severe epilepsy or current use of anticonvulsants
- Severe heart disease (eg heart failure stage III or IV NYHA class, myocardial infarction less than 6 months, ventricular arrhythmia requiring treatment, unstable angina or other significant cardiovascular disease)
- Chronic liver disease other than HBV-related (hemochromatosis, autoimmune hepatitis, metabolic liver disease, including Wilson's disease and a deficiency of alpha1-antitrypsin deficiency, alcoholic liver disease, exposure to toxins)
- Presence or suspicion of cancer or a history of cancer (except basal cell carcinoma or in situ carcinoma) within 5 years preceding the randomization
- Thyroid uncontrolled disease, abnormal TSH, elevated thyroid antibodies and clinical manifestations of thyroid dysfunction
- History of autoimmune disease (inflammatory digestive, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis ....) Or presence of autoantibodies at a significant rate
- Renal impairment (creatinine clearance <50 ml / min using the Cockroft formula), renal transplantation, hemodialysis
- Hypersensitivity to the active substance, interferon alpha or any component
- History of depression or psychiatric disorders and uncontrolled depression or uncontrolled psychiatric disorders
- Pregnancy or breastfeeding, or wish of pregnancy during the study period.
- Patients under legal protection or unable to express their consent
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Saint Joseph, Service d'hépatogastroentérologie
Marseille, 13008
About this study
Official title: A Randomized, Multicenter, Unblinded, Phase III Study Assessing the Loss of HbsAg at W96 After a 48-week Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B (HbeAg Negative) Under Treatment and Responders (Undetectable Viral Load) to a Nucleoside(s) or Nucleotide(s) Analog(s) Treatment for at Least 12 Months. ANRS HB 06 Pegan
The purpose of this study is to assess the loss of HbsAg after a 48-week pegylated interferon alpha 2a in patients with chronic hepatitis B (HBeAg negativation)
Read the detailed description
The purpose of this study is to provide a therapeutical alternative to the use of an extended or undeterminated duration of treatment with prolonged nucleoside (s)/nucleotide (s)analog (s).
The duration of administration is not consensual, and in most cases followed by a virological relapse, so that, the prolonged use could lead to the occurrence of viral resistance and mutations.
It is therefore expected that treatment with pegylated interferon for 48 weeks in patients with undetectable HBV DNA by analog(s) may increase and promotes the loss of HbsAg and then promotes HbsAg seroconversion. In the absence of cirrhosis, the loss of HbsAg at 6 months would allow the end of treatment
- Conditions
- Chronic Hepatitis B, AgHbs Negativation
- Being tested
- Pegylated interferon-alpha-2a, Nucleotidic or Nucleosidic Treatment
- 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.
Pegylated interferon-alpha-2aDrug
180 mcg / wk / SC from D0 to W48
Nucleotidic or Nucleosidic TreatmentDrug
Analog treatment according to investigators practice
| Study group | Role | What they receive |
|---|---|---|
| PegIFN + Nucleosidic or Nucleotidic Analog | Experimental | Not described Receives: Drug: Pegylated interferon-alpha-2a |
| Nucleosidic or Nucleotidic Analog | Active comparator | Not described Receives: Drug: Nucleotidic or Nucleosidic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbsAg negativation at week 96
Percentage of patients with negative HbsAg at W96, i.e 12 months after a 48 weeks treatment with pegylated interferon
Measured: W96
Secondary outcomes (1)
Kinetics of HbsAg
Kinetics of HbsAg under treatment at W-6, W0, W12, W24 and W48 and after discontinuation of PegIFN alpha 2a at W72, W20 and W144
Measured: W-6, W0, W12, W24 and W48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
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 Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Marc BOURLIERE, MD, Study chair, Hôpital Saint Joseph, Service d'hépatogastroentérologie, Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172392
- Sponsor's protocol ID
- 2010-019367-11
- Other IDs
- ANRS HB 06 PEGAN
- Acronym
- PEGAN
- Status last verified
- Feb 2013
- First submitted
- 28 Jul 2010
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bourliere M, Rabiega P, Ganne-Carrie N, Serfaty L, Marcellin P, Barthe Y, Thabut D, Guyader D, Hezode C, Picon M, Causse X, Leroy V, Bronowicki JP, Carrieri P, Riachi G, Rosa I, Attali P, Molina JM, Bacq Y, Tran A, Grange JD, Zoulim F, Fontaine H, Alric L, Bertucci I, Bouvier-Alias M, Carrat F; ANRS HB06 PEGAN Study Group. Effect on HBs antigen clearance of addition of pegylated interferon alfa-2a to nucleos(t)ide analogue therapy versus nucleos(t)ide analogue therapy alone in patients with HBe antigen-negative chronic hepatitis B and sustained undetectable plasma hepatitis B virus DNA: a randomised, controlled, open-label trial. Lancet Gastroenterol Hepatol. 2017 Mar;2(3):177-188. doi: 10.1016/S2468-1253(16)30189-3. Epub 2017 Jan 20.
PubMed 28404133
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Unblinded, Phase III Study Assessing the Loss of HbsAg at W96 After a 48-week Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B (HbeAg Negative) Under Treatment and Responders (Undetectable Viral Load) to a Nucleoside(s) or Nucleotide(s) Analog(s) Treatment for at Least 12 Months. ANRS HB 06 Pegan
- ClinicalTrials.gov ID
- NCT01172392
- Acronym / sponsor ID
- PEGAN / 2010-019367-11
- Conditions
- Chronic Hepatitis B, AgHbs Negativation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Roche Pharma AG
- Study start
- Jan 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 29 Jul 2010 (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.
The purpose of this study is to assess the loss of HbsAg after a 48-week pegylated interferon alpha 2a in patients with chronic hepatitis B (HBeAg negativation)
Detailed description
The purpose of this study is to provide a therapeutical alternative to the use of an extended or undeterminated duration of treatment with prolonged nucleoside (s)/nucleotide (s)analog (s).
The duration of administration is not consensual, and in most cases followed by a virological relapse, so that, the prolonged use could lead to the occurrence of viral resistance and mutations.
It is therefore expected that treatment with pegylated interferon for 48 weeks in patients with undetectable HBV DNA by analog(s) may increase and promotes the loss of HbsAg and then promotes HbsAg seroconversion. In the absence of cirrhosis, the loss of HbsAg at 6 months would allow the end of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PegIFN + Nucleosidic or Nucleotidic Analog | Experimental | Drug: Pegylated interferon-alpha-2a |
| Nucleosidic or Nucleotidic Analog | Active comparator | Drug: Nucleotidic or Nucleosidic Treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Positive Hbs Ag
- Negative HbeAg
- Plasma HBV DNA undetectable at pre-inclusion ever since 12 months
- ALT less than or equal to 5 times the upper limit of normal
- Non cirrhotic or Not Decompensated Cirrhosis (Child Pugh <7)
Key exclusion criteria (20 listed)
- Polymorphonuclear neutrophils <1500/mm3
- Platelets <70.000/mm3
- Co-infections with HIV, HCV and / or HDV
- Prolonged excessive consumption of alcohol
- Active intravenous drug addiction
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 |
|---|---|---|
| Pegylated interferon-alpha-2a180 mcg / wk / SC from D0 to W48 | Drug | PegIFN + Nucleosidic or Nucleotidic Analog |
| Nucleotidic or Nucleosidic TreatmentAnalog treatment according to investigators practice | Drug | Nucleosidic or Nucleotidic Analog |
Primary outcome
HbsAg negativation at week 96
Time frame: W96
Percentage of patients with negative HbsAg at W96, i.e 12 months after a 48 weeks treatment with pegylated interferon
1 secondary outcome
Kinetics of HbsAg
Time frame: W-6, W0, W12, W24 and W48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Derived from this study: PubMed 28404133Bourliere M, Rabiega P, Ganne-Carrie N, Serfaty L, Marcellin P, Barthe Y, Thabut D, Guyader D, Hezode C, Picon M, Causse X, Leroy V, Bronowicki JP, Carrieri P, Riachi G, Rosa I, Attali P, Molina JM, Bacq Y, Tran A, Grange JD, Zoulim F, Fontaine H, Alric L, Bertucci I, Bouvier-Alias M, Carrat F; ANRS HB06 PEGAN Study Group. Effect on HBs antigen clearance of addition of pegylated interferon alfa-2a to nucleos(t)ide analogue therapy versus nucleos(t)ide analogue therapy alone in patients with HBe antigen-negative chronic hepatitis B and sustained undetectable plasma hepatitis B virus DNA: a randomised, controlled, open-label trial. Lancet Gastroenterol Hepatol. 2017 Mar;2(3):177-188. doi: 10.1016/S2468-1253(16)30189-3. Epub 2017 Jan 20.
- French National Agency for Research on AIDS and viral hepatitis websiteLink provided by the sponsor.
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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.
Marc BOURLIERE, MD study chair
Hôpital Saint Joseph, Service d'hépatogastroentérologie, Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegylated interferon-alpha-2a and Nucleotidic or Nucleosidic Treatment in people with Chronic Hepatitis B and AgHbs Negativation, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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 10 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
HbsAg negativation at week 96 (time frame: W96). 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 NCT01172392, 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 29 Mar 2013; AzTrials last refreshed its copy on 7 Nov 2026.