CLINICAL TRIAL WITH PROPHYLACTIC TENOFOVIR FOR HAEMATOLOGICAL CANCER PATIENTS SHOWING A HBc-Ab POSITIVE AND HBs-Ag PATTERN AND TO BE TREATED WITH RITUXIMAB (PREBLIN STUDY)
- Conditions
- CHRONIC HEPATITIS BMedDRA version: 14.1Level: LLTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-000905-30-ES
- Lead Sponsor
- Rafael Esteban Mur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 61
•Male and female patients over 18 years of age
•Patients diagnosed with haematological cancer scheduled to receive treatment with rituximab alone or in combination with other chemotherapy
•Evidence of previous exposure to HBV: HBcAb-positive patients
•HBsAg negative patients
•Signed Informed consent
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 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
• Intolerance to any treatment component.
• Co-infection with HIV.
• Presence of hepatocellular carcinoma
• Patients with severe or moderate renal failure
• Liver or kidney transplant or severe renal, lung or neurological diseases that under investigator criteria may interfere in the patient’s participation during the clinical trial.
• Pregnancy or breastfeeding.
• Treatment within the last 30 days with any experimental (non-authorised) drug.
• Any other disease or condition that might render the patient ineligible for the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method