A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
Launched by HOFFMANN-LA ROCHE · Jan 24, 2012
Trial Information
Current as of June 18, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male or female patients, 3 years to \<18 years of age at baseline
- • Positive HBsAg for more than 6 months
- • Positive HBeAg and detectable HBV DNA at screening
- • A liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of previous therapy for hepatitis B) to confirm the presence of advanced fibrosis or exclude cirrhosis
- • Compensated liver disease (Child-Pugh Class A)
- • Elevated serum alanine transferase (ALT)
- • Normal thyroid gland function at screening
- Exclusion Criteria:
- • Subjects with cirrhosis
- • Subjects must not have received investigational drugs or licensed treatments with anti-HBV activity within 6 months of baseline. Subjects who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded
- • Known hypersensitivity to peginterferon
- • Positive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV infection
- • History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis B
- • History or evidence of bleeding from esophageal varices
- • Decompensated liver disease (e.g. ascites, Child-Pugh Class B or C)
- • History of immunologically mediated disease
- • Pregnant or lactating females
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Seattle, Washington, United States
Gent, , Belgium
Bruxelles, , Belgium
Wuhan, , China
Saint Louis, Missouri, United States
Guangzhou, , China
Moscow, , Russian Federation
Beijing, , China
Guangzhou, , China
London, , United Kingdom
Changchun, , China
London, , United Kingdom
Kunming, , China
Xi'an, , China
Nahariya, , Israel
Jerusalem, , Israel
Haifa, , Israel
San Francisco, California, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
North Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Sofia, , Bulgaria
Varna, , Bulgaria
Beijing City, , China
Chongqing, , China
Urumqi (乌鲁木齐), , China
Wuppertal, , Germany
Bologna, Emilia Romagna, Italy
Bydgoszcz, , Poland
Krakow, , Poland
łodz, , Poland
Moscow, , Russian Federation
Saint Petersburg, , Russian Federation
Samara, , Russian Federation
Kyiv, , Ukraine
Kyiv, , Ukraine
Birmingham, , United Kingdom
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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