A Study of Pegasys in Combination with antiviral HBV oral Lamivudine or Entecavir compared against no treatment in Children Positive but tolerant to Chronic Hepatitis B.

Phase 1

• Conditions: Chronic Hepatitis B Virus infection; MedDRA version: 20.0Level: LLTClassification code 10019743Term: Hepatitis B virus (HBV)System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2006-000977-31-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-08
• Study Completion: 2020-01-29
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Male and female patients 3 to less than 18 years of age at baseline (12 to < 18 years of age at baseline in Russia and India)
• Positive for HBsAg and HBeAg for more than 6 months prior to baseline
• Detectable HBV-DNA (> 20,000 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: 114
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

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