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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01519960
First received: December 6, 2011
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This parallel group, open label study will evaluate the safety and efficacy of P egasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B. Children wit hout 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 i n 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 tre atment. This offer will be available for 1 year following 48 weeks from randomiz ation. Anticipated time on study treatment is 48 weeks. All subjects will be fol lowed up for 5 years after the end of treatment (A,C,Switch)/principal observati on (B) period.


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

Study Type: Interventional
Study Design: Allocation: Non-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 ]

Estimated Enrollment: 160
Study Start Date: July 2012
Estimated Study Completion Date: March 2023
Estimated Primary Completion Date: March 2023 (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
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

Contacts
Contact: Reference Study ID Number: YV25718 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 44 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

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: October 20, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014