Research study, conducted in patients with chronic hepatitis B, during treatment with nucleos(t)ide analogues (NA), with the aim to assess the effect of the administration of peginterferon alfa-2a (PEG-IFN) for 48 weeks, on the improvement of treatment responses.

• Conditions: Chronic Hepatitis B; MedDRA version: 15.0Level: LLTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-000080-25-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-09
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Adults (aged 18-65) with chronic hepatitis B.
•Negative for HBeAg.
•Infected with HBV genotype D.
•In monotherapy with any NA but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months.
•HBsAg >100 IU/ml at the beginning of the Lead-In phase, confirmed before addition of PEG-IFN.
•Showing a steady HBsAg kinetic (HBsAg decrease <0.5 log10 IU/ml from week -12 to start of the Add-On phase.
•Negative pregnancy test (for women of childbearing potential) documented at baseline (prior to the first dose of PEG-IFN). Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during and for 3 months after the Add-On phase
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 81
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Co-infection with HAV, HCV, HDV, HIV.
•Evidence of decompensated liver disease (Child-Pugh =6).
•History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
•Known hypersensitivity to PEG-IFN.
•Women with ongoing pregnancy or who are breast feeding.
•Neutrophil count <1500 cells/mmc, platelet count <100,000 cells/mmc or hemoglobin <11 g/dL for females and <12 g/dL for males.
•Evidence of alcohol and/or drug abuse within one year of study entry.
•History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.
•History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).
•History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease.
•History or other evidence of chronic pulmonary disease associated with functional limitation.
•History of severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases).
•History of a severe seizure disorder or current anticonvulsant use.
•Evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in-situ cervical carcinoma) within a period of 5 years prior to study entry. Patients with a lesion suspicious of hepatic malignancy will be excluded.
•History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory treatment (including systemic corticosteroids) = 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
•History of major organ transplantation with an existing functional graft (other than corneal or hair transplantation).
•History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded.
•History or other evidence of severe retinopathy.
•Inability or unwillingness to provide informed consent or abide by the requirements of the study.
•History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
•Serum alfa-fetoprotein > 50 mg/ml.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified