A Study of Pegasys in Combination with antiviral HBV oral Lamivudine or entecavir compared against no treatment in Children Positive but tolerant to Chronic Hepatitis B.

PHASE IIIB, RANDOMIZED, OPEN LABEL STUDY OF PEGYLATED INTERFERON ALFA-2A IN COMBINATION WITH LAMIVUDINE OR ENTECAVIR COMPARED WITH UNTREATED CONTROL PATIENTS IN CHILDREN WITH HBEAG POSITIVE CHRONIC HEPATITIS B IN THE IMMUNE TOLERANT PHASE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000977-31-GB

Enrollment

114

Registered

2006-03-31

Start date

2006-05-05

Completion date

Unknown

Last updated

2019-01-07

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

Conditions

Chronic Hepatitis B Virus infection MedDRA version: 20.0 Level: LLT Classification code 10019743 Term: Hepatitis B virus (HBV) System Organ Class: 100000004848

Interventions

Trade Name: Pegasys Product Name: Pegasys Product Code: RO025-8310 Pharmaceutical Form: Injection INN or Proposed INN: PEGINTERFERON ALFA 2A CAS Number: 76543-88-9 Current Sponsor code: RO025-8310/J13

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male and female patients 3 to less than 18 years of age at baseline (12 20,000 IU/mL as measured by PCR or hybridization) on at least 2 occasions at least one month apart with the latest determination obtained = 42 days prior to baseline. Are the trial subjects under 18? yes Number of subjects for this age range: 114 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: Patients who have had any previous anti-HBV treatment, or who are co-infected with hepatitis A virus (HAV), HCV, hepatitis D virus (HDV) or HIV, or who have decompensated liver disease will beexcluded.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of Pegasys® + lamivudine or entecavir compared with an untreated control in children with CHB, as measured by loss of HBsAg 24 weeks post-end of treatment/end of untreated observation.;Secondary Objective: •To evaluate efficacy of Pegasys® + lamivudine or entecavir compared with an untreated control in children with CHB, as measured by seroconversion to anti-HBs, seroconversion to anti-HBe, loss of HBeAg, and HBV DNA levels, at 24 weeks post-end of treatment/end of untreated observation. •To evaluate efficacy of Pegasys® + lamivudine or entecavir in children with CHB, as measured by seroconversion to anti-HBs, seroconversion to anti-HBe, loss of HBsAg, loss of HBeAg, HBV DNA levels at 1 year post-end of treatment. ;Primary end point(s): Loss of HBsAg at 24 weeks post-end of treatment (follow-up Week 24)/end of untreated observation (Week 80).;Timepoint(s) of evaluation of this end point: At 24 weeks post-end of treatment (follow-up Week 24)/end of untreated observation (Week 80)	—

Measure

Time frame

Main Objective: To evaluate the efficacy of Pegasys® + lamivudine or entecavir compared with an untreated control in children with CHB, as measured by loss of HBsAg 24 weeks post-end of treatment/end of untreated observation.;Secondary Objective: •To evaluate efficacy of Pegasys® + lamivudine or entecavir compared with an untreated control in children with CHB, as measured by seroconversion to anti-HBs, seroconversion to anti-HBe, loss of HBeAg, and HBV DNA levels, at 24 weeks post-end of treatment/end of untreated observation. •To evaluate efficacy of Pegasys® + lamivudine or entecavir in children with CHB, as measured by seroconversion to anti-HBs, seroconversion to anti-HBe, loss of HBsAg, loss of HBeAg, HBV DNA levels at 1 year post-end of treatment. ;Primary end point(s): Loss of HBsAg at 24 weeks post-end of treatment (follow-up Week 24)/end of untreated observation (Week 80).;Timepoint(s) of evaluation of this end point: At 24 weeks post-end of treatment (follow-up Week 24)/end of untreated observation (Week 80)

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Secondary

Measure	Time frame
Secondary end point(s): The secondary efficacy endpoints for this study at 24 weeks post-end of treatment/end of untreated observation are as follows: 1 Seroconversion to anti-HBs (loss of HBsAg and presence of anti-HBs) 2 Seroconversion to anti-HBe (loss of HBeAg and presence of anti-HBe) 3 Loss of HBeAg 4 HBV DNA < 20,000 IU/mL, 2000 IU/mL , undetectable and change from baseline (by PCR or hybridization) 5 Combined endpoints: HBeAg seroconversion and HBV DNA < 20,000 IU/mL 6 Combined endpoints: HBeAg seroconversion and HBV DNA < 2000 IU/mL At 1 year post-treatment: 7 Seroconversion to anti-HBs (loss of HBsAg and presence of anti-HBs) 8 Seroconversion to anti-HBe (loss of HBeAg and presence of anti-HBe) 9 Loss of HBsAg and HBeAg 10 HBV DNA < 20,000 IU/mL, < 2000 IU/mL, undetectable and change from baseline (by PCR or hybridization) 11 Combined endpoints: HBeAg seroconversion and HBV DNA < 20,000 IU/mL 12 Combined endpoints: HBeAg seroconversion and HBV DNA < 2000 IU/mL;Timepoint(s) of evaluation of this end point: 1-6. At 24 weeks post-end of treatment/end of untreated observation 7-12. At 1 year post-treatment	—

Measure

Time frame

Secondary end point(s): The secondary efficacy endpoints for this study at 24 weeks post-end of treatment/end of untreated observation are as follows: 1 Seroconversion to anti-HBs (loss of HBsAg and presence of anti-HBs) 2 Seroconversion to anti-HBe (loss of HBeAg and presence of anti-HBe) 3 Loss of HBeAg 4 HBV DNA < 20,000 IU/mL, 2000 IU/mL , undetectable and change from baseline (by PCR or hybridization) 5 Combined endpoints: HBeAg seroconversion and HBV DNA < 20,000 IU/mL 6 Combined endpoints: HBeAg seroconversion and HBV DNA < 2000 IU/mL At 1 year post-treatment: 7 Seroconversion to anti-HBs (loss of HBsAg and presence of anti-HBs) 8 Seroconversion to anti-HBe (loss of HBeAg and presence of anti-HBe) 9 Loss of HBsAg and HBeAg 10 HBV DNA < 20,000 IU/mL, < 2000 IU/mL, undetectable and change from baseline (by PCR or hybridization) 11 Combined endpoints: HBeAg seroconversion and HBV DNA < 20,000 IU/mL 12 Combined endpoints: HBeAg seroconversion and HBV DNA < 2000 IU/mL;Timepoint(s) of evaluation of this end point: 1-6. At 24 weeks post-end of treatment/end of untreated observation 7-12. At 1 year post-treatment

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Countries

Australia, Belgium, Germany, Italy, Malaysia, Romania, Russian Federation, Taiwan, Turkey, 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