A Phase IIIb study to openly compare a group treated with only pegylated interferon alfa-2a (PEG-IFN) to an untreated group in children with chronic hepatitis B (CHB) who are HBeAg positive (a marker of their stage of CHB infection).

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 in the Immune Active Phase.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002732-70-GB

Enrollment

160

Registered

2011-08-31

Start date

2012-02-09

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of HBeAg positive chronic hepatitis B (CHB) in children. MedDRA version: 16.0 Level: LLT Classification code 10052552 Term: Hepatitis B virus System Organ Class: 100000004848

Interventions

Trade Name: Pegasys® Pharmaceutical Form: Solution for injection INN or Proposed INN: PEGINTERFERON ALFA-2A CAS Number: 198153-51-4 Current Sponsor code: Ro 25-8310 Other descriptive name: PEG-IFN Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children aged 3 to 10,000 copies/mL [>2,000 IU/ml]) by PCR and ALT >ULN but =10 x ULN (using the local sites’ reference range). Liver biopsy needs to have been conducted within the previous 2 years. Are the trial subjects under 18? yes Number of subjects for this age range: 160 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

Exclusion criteria: Subjects co-infected with HCV, HDV, HIV, or who have received therapy for hepatitis B in the prior 6 months, or have cirrhosis, or who have de-compensated liver disease will be excluded.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare HBeAg seroconversion (loss of HBeAg and presence of anti-HBe) between a group treated with PEG-IFN monotherapy and an untreated control group. ;Secondary Objective: To examine the short and longer term effects on various efficacy and safety measures between a group treated with PEG-IFN monotherapy and an untreated control group, and to evaluate pharmacokinetics (PK) in PEG-IFN treated subjects.;Primary end point(s): HBeAg seroconversion (loss of HBeAg and presence of anti-HBe).;Timepoint(s) of evaluation of this end point: At the 24 week post-treatment/principal observation period follow-up visit.	—

Measure

Time frame

Main Objective: To compare HBeAg seroconversion (loss of HBeAg and presence of anti-HBe) between a group treated with PEG-IFN monotherapy and an untreated control group. ;Secondary Objective: To examine the short and longer term effects on various efficacy and safety measures between a group treated with PEG-IFN monotherapy and an untreated control group, and to evaluate pharmacokinetics (PK) in PEG-IFN treated subjects.;Primary end point(s): HBeAg seroconversion (loss of HBeAg and presence of anti-HBe).;Timepoint(s) of evaluation of this end point: At the 24 week post-treatment/principal observation period follow-up visit.

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Secondary

Measure	Time frame
Secondary end point(s): • Loss of HBeAg, HBsAg seroconversion (loss of HBsAg and presence of anti-HBs), loss of HBsAg, quantitative serum ALT, proportion of normal ALT, quantitative HBV DNA, suppression of HBV DNA <100,000 copies/mL (<20,000 IU/mL), <10,000 copies/mL (<2,000 IU/mL), undetectable and change from baseline, combined endpoint of HBeAg seroconversion and HBV DNA <100,000 copies/mL (<20,000 IU/mL), and combined endpoint of HBeAg seroconversion and HBV DNA <10,000 copies/mL (<2,000 IU/mL). • Persistence HBeAg seroconversion (loss of HBeAg and presence of anti-HBe). • Descriptive change in liver elasticity (in liver elasticity sub-study subjects). ;Timepoint(s) of evaluation of this end point: • At the end of treatment/principal observation period, at 24 weeks after end of treatment/principal observation period, and at 1, 2, 3, 4 and 5 years after end of treatment/principal observation period. • At the end of treatment/principal observation period, and at 1, 2, 3, 4 and 5 years after end of treatment/principal observation period. • At 24 weeks and 2 years after end of treatment/principal observation period. • At 24 weeks after end of treatment.	—

Measure

Time frame

Secondary end point(s): • Loss of HBeAg, HBsAg seroconversion (loss of HBsAg and presence of anti-HBs), loss of HBsAg, quantitative serum ALT, proportion of normal ALT, quantitative HBV DNA, suppression of HBV DNA <100,000 copies/mL (<20,000 IU/mL), <10,000 copies/mL (<2,000 IU/mL), undetectable and change from baseline, combined endpoint of HBeAg seroconversion and HBV DNA <100,000 copies/mL (<20,000 IU/mL), and combined endpoint of HBeAg seroconversion and HBV DNA <10,000 copies/mL (<2,000 IU/mL). • Persistence HBeAg seroconversion (loss of HBeAg and presence of anti-HBe). • Descriptive change in liver elasticity (in liver elasticity sub-study subjects). ;Timepoint(s) of evaluation of this end point: • At the end of treatment/principal observation period, at 24 weeks after end of treatment/principal observation period, and at 1, 2, 3, 4 and 5 years after end of treatment/principal observation period. • At the end of treatment/principal observation period, and at 1, 2, 3, 4 and 5 years after end of treatment/principal observation period. • At 24 weeks and 2 years after end of treatment/principal observation period. • At 24 weeks after end of treatment.

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Countries

Australia, Belgium, Brazil, Bulgaria, China, Germany, Israel, Italy, Malaysia, Poland, Russian Federation, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026