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
NCT ID: NCT01172392
Last Updated: 2013-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
185 participants
INTERVENTIONAL
2011-01-31
2015-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PegIFN + Nucleosidic or Nucleotidic Analog
Pegylated interferon-alpha-2a
180 mcg / wk / SC from D0 to W48
Nucleosidic or Nucleotidic Analog
Nucleotidic or Nucleosidic Treatment
Analog treatment according to investigators practice
Interventions
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Pegylated interferon-alpha-2a
180 mcg / wk / SC from D0 to W48
Nucleotidic or Nucleosidic Treatment
Analog treatment according to investigators practice
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Marc BOURLIERE, MD
Role: STUDY_CHAIR
Hôpital Saint Joseph, Service d'hépatogastroentérologie, Marseille
Locations
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Hôpital Saint Joseph, Service d'hépatogastroentérologie
Marseille, , France
Countries
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References
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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.
Related Links
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French National Agency for Research on AIDS and viral hepatitis website
Other Identifiers
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2010-019367-11
Identifier Type: -
Identifier Source: org_study_id
ANRS HB 06 PEGAN
Identifier Type: OTHER
Identifier Source: secondary_id