Subject with new diagnosis of solid or haematological cancer in inactive carrier in chronic virus B infected patients MedDRA version: 9.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ENTECAVIR
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: .5-
Sponsors
AISF - ASSOCIAZIONE ITALIANA PER LO STUDIO DEL FEGATO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written Informed Consent § Male or female > 18 year of age § New histological and / or clinical diagnosis of solid or haematological cancer § First-line Chemotherapy and / or immunosuppressive treatment for a scheduled time § inactive carrier in chronic virus B infected patients (HBsAg positive, anti-HBe positive, HBV-DNA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Evidence of clinical or histological chronic liver disease due to virus B infection with values of HBV-DNA> 20,000 / ml (HBV active carriers) - Other viral infections (anti-HCV positive, anti-HDV positive) - Creatinine> 1.5 mg / dL C - Pregnancy or lactation - Heart Diseases with serious cardiac dysfunction, congestive heart failure, recent myocardial infarction, severe hypertension or untreated arrhythmia - Other medical conditions that in the opinion of investigators might influence the course of cancer or can interfere with the effectiveness of antiviral therapy. - Bone marrow transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study aims to assess the ability of Entecavir therapy to maintain the suppression of HBV replication during chemotherapy and avoid the clinical events related to the HBV reactivation.;Secondary Objective: To evaluate Entecavir tolerability in HbsAG positive carriers with solid or hematological cancers undergoing chemotherapy;Primary end point(s): Maintenance of serum HBV-DNA levels below 200 IU / ml during the whole period of chemotherapy and 6 (or 12) months thereafter | — |
Countries
Italy
Outcome results
None listed