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Interferon

LdT+ PEG-INF for Hepatitis B

Phase 3
Waitlist Available
Research Sponsored by Novartis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 18, 24, 48, 52 and treatment completion (tc)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.

Eligible Conditions
  • Hepatitis B

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 18, 24, 48, 52 and treatment completion (tc)
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 18, 24, 48, 52 and treatment completion (tc) for reporting.

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 Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Peginterferon Alpha-2a Monotherapy
Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB)
Secondary study objectives
Change From Baseline in HBV DNA Concentration
Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Telbivudine Monotherapy
Percentage of Participants Who Achieved HBV DNA Non-detectability With Telbivudine Monotherapy Versus Peginterferon Alpha-2a Monotherapy
+2 more

Awards & 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: LdT+ PEG-INFExperimental Treatment2 Interventions
Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peginterferon alpha-2a (PEG-INF)180 μg subcutaneous injection once a week for 52 weeks.
Group II: LdT MonotherapyExperimental Treatment1 Intervention
Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
Group III: PEG-INF MonotherapyActive Control1 Intervention
Peginterferon alpha-2a (PEG- INF) monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telbivudine
FDA approved

Find a Location

Who is running the clinical trial?

NovartisLead Sponsor
1,633 Previous Clinical Trials
2,728,999 Total Patients Enrolled
13 Trials studying Hepatitis B
1,915 Patients Enrolled for Hepatitis B
~8 spots leftby Oct 2025
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