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NCT02263079 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
62
Enrollment target

NCT02263079: Completed Phase 3 study, sponsored by Hoffmann-La Roche.

NCT02263079 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02263079, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
62 participants
Enrollment target

Study 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

Primary Outcome

This endpoint is defined as loss of HBsAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80). The percentage of responders (response rate) and 95% CI (using the Clopper-Pearson method) for the response rate are presented for each group.

Interventions

  • DRUG Lamivudine
  • DRUG Entecavir
  • DRUG Pegylated Interferon Alfa-2A

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2014-06-16
Est. Completion 2020-01-29
Phase Phase 3
Hoffmann-La Roche

909 total trials

What the finished NCT02263079 record still lists

NCT02263079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 3 interventions - of which Lamivudine is the first listed.

NCT02263079 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02263079 about?

NCT02263079 is a clinical study titled "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". 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 toler...

What is the current status of trial NCT02263079?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2014-06-16. Estimated completion is 2020-01-29.

What interventions are being tested in trial NCT02263079?

The interventions under investigation include: Lamivudine (DRUG), Entecavir (DRUG), Pegylated Interferon Alfa-2A (DRUG).

Who is sponsoring clinical trial NCT02263079?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02263079's enrollment target sits among peer trials

62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02263079, the US trial registry maintained by the National Library of Medicine. NCT02263079 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.