Effect of a Peg-interferon alfa 2A pulse on HBV-specific T cell responses in chronic hepatitis HBeAg negative patients under long-term nucleos(t)ide treatment

Azienda Ospedaliero-Universitaria di Parma0 sitesStarted: October 2, 2014Last updated: March 9, 2015

Conditions

Drugs

Trial Snapshot

No summary available.

•1.willingness to participate in the study protocol and to provide informed consent
•2.male and female, age between 18 and 70 years
•3.HBeAg negative/anti-HBe positive chronic hepatitis B (+/- cirrhosis) proven by histology or non invasive techniques (Fibroscan) before entry
•4.if cirrhosis is present, absence of portal hypertension, HCC and ?-FP levels <200 ng has to be documented at screening
•5.complete viral suppression on nucleos(t)ide analogues (HBV-DNA undetectable < 20 IU/ml) from 2-3 years
•6.serum albumine >3.5 gr/dL, bilirubin < 1.5 mg/dL
•7.Absolute neutrophil count >1,500 cells/mm3; PLTs >90,000/ mm3
•8.Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile male patients with female partners of childbearing age and females must be using two reliable forms of effective contraception (combined) during the study and for 3 months after treatment completion.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 72
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•1.Child B or C cirrhosis
•2.women who are pregnancy, intent to become pregnant, or who are breast feeding
•3.history of severe psychiatric disease, especially depression
•4.history of neurological disease, especially epilepsy
•5.Addison disease
•6.hypertension (PA sis > 170 mmHg; PA dia > 100 mmHg)
•7.history or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease
•8.ALT = 10xULN
•9.positive anti-HDV; positive anti-HCV; positive anti-HIV
•10.positive ANA and/or ASMA (> 1/40)
•11.antiviral therapy with Interferon in the previous 3 years
•12.use of systemic anti-neoplastic or immunomodulatory treatments in the previous 6 months
•13.retynopathies
•14.tyreopathies
•15.history or other evidence of severe illness or any other conditions which would make the patients, in the opinion of investigator, unsuitable for the study.

Sponsor