A Study of Pegasys in Combination with antiviral HBV oral Lamivudine or entecavir compared against no treatment in Children Positive buttolerant to Chronic Hepatitis B.
- Conditions
- Chronic Hepatitis B Virus infection in children.MedDRA version: 20.0Level: LLTClassification code 10019743Term: Hepatitis B virus (HBV)System Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2006-000977-31-IT
- Lead Sponsor
- F. HOFFMANN - LA ROCHE LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 59
• Male and female patients 3 to less than 18 years of age at baseline (12– 17 years of age at baseline in Russia)
• Positive for HBsAg and HBeAg for more than 6 months prior to baseline
• Detectable HBV-DNA (> 10,000 copies/mL [> 2000 IU/mL]) (as measured by PCR or hybridization) on at least 2 occasions at least one month apart with the latest determination obtained = 42 days prior to
baseline.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
Patients who have had any previous anti-HBV treatment, or who are co-infected with hepatitis A virus (HAV), HCV, hepatitis D virus (HDV) or HIV, or who have decompensated 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 evaluate the efficacy of Pegasys¿ + lamivudine compared with an untreated control in children with CHB, as measured by loss of HBsAg 24 weeks post-end of treatment/end of untreated observation.;Secondary Objective: ¿To evaluate efficacy of Pegasys¿ + lamivudine compared with an untreated control in children with CHB, as measured by seroconversion to anti-HBs, seroconversion to anti-HBe, loss of HBeAg, and HBV DNA levels, at 24 weeks post-end of treatment/end of untreated observation <br>¿ To evaluate efficacy of Pegasys¿ + lamivudine in children with CHB, as measured by seroconversion to anti-HBs, seroconversion to anti-HBe, loss of HBsAg, loss of HBeAg, HBV DNA levels, and at 1, 2, 3, 4, and 5 years post-end of treatment ;Primary end point(s): The primary efficacy endpoint is defined as loss of HBsAg at 24 weeks post-end of treatment (follow-up Week 24)/end of untreated observation (Week 80).;Timepoint(s) of evaluation of this end point: Please refer to E.5.1
- Secondary Outcome Measures
Name Time Method