A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01519960
First received: December 6, 2011
Last updated: May 13, 2013
Last verified: May 2013
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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: 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: | May 2022 |
| Estimated Primary Completion Date: | May 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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519960
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Contacts
| Contact: Please reference Study ID Number: YV25718 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Hide Study LocationsLocations
| United States, California | |
| Recruiting | |
| San Francisco, California, United States, 94143 | |
| United States, Maryland | |
| Recruiting | |
| Baltimore, Maryland, United States, 21287-5554 | |
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Recruiting | |
| St. Louis, Missouri, United States, 63104 | |
| United States, Texas | |
| Active, not recruiting | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Recruiting | |
| Seattle, Washington, United States, 98105 | |
| Australia | |
| Recruiting | |
| Melbourne, Australia, 3053 | |
| Recruiting | |
| North Adelaide, Australia, 5006 | |
| Recruiting | |
| Sydney, Australia, 2145 | |
| Belgium | |
| Recruiting | |
| Brussels, Belgium, 1200 | |
| Recruiting | |
| Gent, Belgium, 9000 | |
| Bulgaria | |
| Recruiting | |
| Sofia, Bulgaria, 1612 | |
| Recruiting | |
| Varna, Bulgaria, 9000 | |
| China | |
| Not yet recruiting | |
| Beijing, China, 100054 | |
| Not yet recruiting | |
| Beijing, China, 100039 | |
| Not yet recruiting | |
| Chongqing, China, 400038 | |
| Not yet recruiting | |
| Fuzhou, China, 350025 | |
| Not yet recruiting | |
| Guangzhou, China, 510630 | |
| Not yet recruiting | |
| Guangzhou, China, 510060 | |
| Not yet recruiting | |
| Kunming, China, 650032 | |
| Not yet recruiting | |
| Shanghai, China, 200025 | |
| Not yet recruiting | |
| Xi An City, China, 710061 | |
| Germany | |
| Active, not recruiting | |
| Wuppertal, Germany, 42283 | |
| Israel | |
| Recruiting | |
| Haifa, Israel, 31096 | |
| Recruiting | |
| Jerusalem, Israel, 91200 | |
| Recruiting | |
| Zefat, Israel, 13100 | |
| Italy | |
| Active, not recruiting | |
| Bologna, Italy, 40138 | |
| Recruiting | |
| Torino, Italy, 10126 | |
| Poland | |
| Recruiting | |
| Bydgoszcz, Poland, 85-030 | |
| Recruiting | |
| Krakow, Poland, 31-202 | |
| Active, not recruiting | |
| ODZ, Poland, 91-347 | |
| Recruiting | |
| Poznan, Poland, 60-693 | |
| Russian Federation | |
| Active, not recruiting | |
| Moscow, Russian Federation, 119991 | |
| Recruiting | |
| Moscow, Russian Federation, 115446 | |
| Not yet recruiting | |
| Novokuznetsk, Russian Federation, 654063 | |
| Active, not recruiting | |
| Saint Petersburg, Russian Federation, 197022 | |
| Active, not recruiting | |
| Samara, Russian Federation, 443100 | |
| Ukraine | |
| Recruiting | |
| Kyiv, Ukraine, 01119 | |
| Recruiting | |
| Kyiv, Ukraine, 04050 | |
| United Kingdom | |
| Recruiting | |
| Birmingham, United Kingdom, B4 6NH | |
| Recruiting | |
| London, United Kingdom, SE5 9RS | |
| Recruiting | |
| London, United Kingdom, W2 1NY | |
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: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Hepatitis, Viral, Human Liver Diseases Digestive System Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013