Peginterferon alfa-2a and Ribavirin Combination Therapy in Patients with HBeAg-negative Chronic HBV Infection - PARC study
- Conditions
- chronic HBV infection
- Registration Number
- EUCTR2004-004736-30-AT
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 122
- Chronic hepatitis B (HBsAg positive > 6 months)
- Biopsy performed within one year prior to screening or during screening
- ALT > 1.5 x ULN on two occasions within 2 months prior to randomization (normal ALT values in between are allowed)
- HBeAg negative, anti-HBeAg positive on two occasions within 2 months prior to randomization
- HBV DNA > 105 copies/ml (centrally measured by Taqman PCR) within 2 months prior to randomization
- Age 18-70 years
- Written informed consent
- Hepatic imaging (US, CT or MRI) without evidence of hepatocellular carcinoma within 3 months prior to randomization
- Adequate contraception for males and females during treatment and follow up (written confirmation); negative pregnancy test (for women of childbearing potential)
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
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
- Antiviral therapy against HBV within the previous 6 months; treatment with any investigational drug within 30 days of entry to this protocol
- Severe hepatitis activity as documented by ALT>10 x ULN
- Advanced liver disease
- Pre-existent leucopenia or thrombopenia
- Co-infection with hepatitis C, hepatitis D or human immunodeficiency virus (HIV)
- Other acquired or inherited causes of liver disease
- Alpha fetoprotein > 50 ng/ml.
- Serum creatinine level > 1.5 times the upper limit of normal at screening or evidence of severe renal disease
- Hyper- or hypothyroidism (Subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met.)
- Other significant medical illness that might interfere with this study: significant cardiovascular or pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)
- Immune suppressive treatment within the previous 6 months
- Pregnancy, breast-feeding
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