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Nucleoside Analog Reverse Transcriptase Inhibitor
A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks post-treatment /end of untreated observation (week 80), and 1 year post-end of treatment (end of treatment = week 56)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial
Summary
This randomized, controlled, parallel group, open-label multicenter study will evaluate the efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus lamivudine or entecavir compared with an untreated control group in participants with HBeAg positive CHB in the immune tolerant phase. NOTE: STUDY RECRUITMENT HAS BEEN TERMINATED
Eligible Conditions
- Chronic Hepatitis B
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks post-treatment /end of untreated observation (week 80), and 1 year post-end of treatment (end of treatment = week 56)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks post-treatment /end of untreated observation (week 80), and 1 year post-end of treatment (end of treatment = week 56)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) at 24 Weeks Post-End of Treatment/End of Untreated Observation
Secondary study objectives
Change From Baseline in HBV DNA Levels in the Peg-INF-Alfa-2A (Treated) Arm
Change From Baseline in HBV DNA Levels in the Untreated Control Participants
Percentage of Participants With AEs Leading to Dose Modification or Interruption
+9 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Peg-INF-Alfa-2A MonotherapyExperimental Treatment1 Intervention
Participants will receive Peginterferon Alfa 2A subcutaneously once weekly with dosing based on body surface area (BSA) categories for 48 weeks.
Group II: Peg-IFN-Alfa-2A + Lamivudine or EntecavirExperimental Treatment3 Interventions
Participants will receive lamivudine or entecavir alone for 8 weeks followed by peg-IFN-alfa-2A in combination with lamivudine or entecavir for 48 weeks.
Group III: Untreated Control ParticipantsActive Control1 Intervention
Untreated control participants will be observed up to 80 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Entecavir
FDA approved
Lamivudine
FDA approved
Peginterferon alfa-2a
FDA approved
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,463 Previous Clinical Trials
1,103,065 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,233 Previous Clinical Trials
902,175 Total Patients Enrolled