A Phase IIIb study to openly compare a group treated with only pegylated interferon alfa-2a (PEG-IFN) to an untreated group in children with chronic hepatitis B (CHB) who are HBeAg positive (a marker of their stage of CHB infection).
Phase 1
- Conditions
- Treatment of HBeAg positive chronic hepatitis B (CHB) in children.MedDRA version: 20.0Level: LLTClassification code 10052552Term: Hepatitis B virusSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-002732-70-PL
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 161
Inclusion Criteria
Children aged 3 to <18 years of age with CHB, HBeAg+ve, HBsAg+ve, detectable HBV DNA (>10,000 copies/mL [>2,000 IU/ml]) by PCR and ALT >ULN but =10 x ULN (using the local sites' reference range). Liver biopsy needs to have been conducted within the previous 2 years.
Are the trial subjects under 18? yes
Number of subjects for this age range: 160
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Subjects co-infected with HCV, HDV, HIV, or who have received therapy for hepatitis B in the prior 6 months, or have cirrhosis, or who have de-compensated liver disease will be excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare HBeAg seroconversion (loss of HBeAg and presence of anti-HBe) between a group treated with PEG-IFN monotherapy and an untreated control group. <br>;Secondary Objective: To examine the short and longer term effects on various efficacy and safety measures between a group treated with PEG-IFN monotherapy and an untreated control group, and to evaluate pharmacokinetics (PK) in PEG-IFN treated subjects.;Primary end point(s): HBeAg seroconversion (loss of HBeAg and presence of anti-HBe).;Timepoint(s) of evaluation of this end point: At the 24 week post-end of-treatment/principal observation period.
- Secondary Outcome Measures
Name Time Method