A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01519960
First received: December 6, 2011
Last updated: June 1, 2016
Last verified: June 2016
  Purpose
This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment with Pegasys. Children in the untreated control Group B who have not experienced seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of Pegasys treatment. This offer will be available for 1 year following 48 weeks from randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon Alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • HBeAg seroconversion (loss of HBeAg and presence of anti-HBe) 24 weeks after end of treatment/principal observation period with a further 4.5 years of follow-up [ Time Frame: 24 weeks post-treatment/principal observation period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HBsAg seroconversion (loss of HBsAg and presence of anti-HBs) [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Loss of HBeAg/HBsAg [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Serum alanine aminotransferase (ALT) levels [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Proportion of normal ALT [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • HBV DNA levels [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Change in liver elasticity (elastography) [ Time Frame: from baseline to Week 72 ] [ Designated as safety issue: No ]
  • Group C: Change in histological findings (liver biopsy) [ Time Frame: from baseline to Week 72 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Weeks 1 and 24, pre-dose and 24-48, 72-96 and 168 hours post-dose ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Safety: Growth [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: July 2012
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Pegasys Drug: peginterferon alfa-2a [Pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48
No Intervention: B Untreated Control
Experimental: C Fibrosis non-randomized Drug: peginterferon alfa-2a [Pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48
Experimental: Switch Drug: peginterferon alfa-2a [Pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, after Week 48 for Group B patients who have not experienced HBeAg seroconversion

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Negative anti-HBs and anti-HBe 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519960

  Hide Study Locations
Locations
United States, California
San Francisco, California, United States, 94143
United States, Maryland
Baltimore, Maryland, United States, 21287-5554
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis, Missouri, United States, 63104
United States, Texas
Houston, Texas, United States, 77030
United States, Washington
Seattle, Washington, United States, 98105
Australia, New South Wales
Sydney, New South Wales, Australia, 2145
Australia, South Australia
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Melbourne, Victoria, Australia, 3053
Belgium
Bruxelles, Belgium, 1200
Gent, Belgium, 9000
Bulgaria
Sofia, Bulgaria, 1612
Varna, Bulgaria, 9000
China
Beijing, China, 100039
Beijing, China, 100069
Changchun, China, 130021
Chongqing, China, 400038
Guangzhou, China, 510060
Guangzhou, China, 510630
Kunming, China, 650032
Shanghai, China, 200235
Urumqi (乌鲁木齐), China, 830000
Wuhan, China, 430030
Xi'an, China, 710061
Germany
Wuppertal, Germany, 42283
Israel
Haifa, Israel, 31096
Jerusalem, Israel, 9112001
Nahariya, Israel, 22100
Italy
Bologna, Emilia-Romagna, Italy, 40138
Torino, Piemonte, Italy, 10126
Poland
Bydgoszcz, Poland, 85-030
Krakow, Poland, 31-202
Poznan, Poland, 60-693
Łodz, Poland, 91-347
Russian Federation
Arkhangelsk, Russian Federation, 163045
Moscow, Russian Federation, 115446
Moscow, Russian Federation, 119991
Saint Petersburg, Russian Federation, 197022
Samara, Russian Federation, 443100
Ukraine
Kyiv, Ukraine, 01119
Kyiv, Ukraine, 04050
United Kingdom
Birmingham, United Kingdom, B4 6NH
London, United Kingdom, SE5 9RS
London, United Kingdom, W2 1PG
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01519960     History of Changes
Other Study ID Numbers: YV25718  2011-002732-70 
Study First Received: December 6, 2011
Last Updated: June 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016