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NCT01369199 · ClinicalTrials.gov registry record · Phase 3

Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B

A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Terminated
Registry status
Phase 3
Development phase
28
Enrollment target

NCT01369199: Clinical Trial Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT01369199 is a Phase 3 study that was terminated before completion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 28 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01369199, a Phase 3 study, was terminated before completion, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

TERMINATED
Registry status
Phase 3
Development phase
28 participants
Enrollment target

Study Summary

The investigators evaluated the safety and efficacy of a short lead-in course (8 weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40 weeks.

Primary Outcome

Lack of data was considered to be treatment failure.

Interventions

  • DRUG Entecavir and peginterferon

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2012-05
Est. Completion 2017-02-14
Phase Phase 3

Why NCT01369199 stopped before completion

NCT01369199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Entecavir and peginterferon is the first listed.

NCT01369199 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01369199 about?

NCT01369199 is a clinical study titled "Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B". The investigators evaluated the safety and efficacy of a short lead-in course (8 weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40 weeks.

What is the current status of trial NCT01369199?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 28 participants. The study started on 2012-05. Estimated completion is 2017-02-14.

What interventions are being tested in trial NCT01369199?

The interventions under investigation include: Entecavir and peginterferon (DRUG).

Who is sponsoring clinical trial NCT01369199?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01369199's enrollment target sits among peer trials

28 1935th of 2000 higher than 65 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 NCT01369199, the US trial registry maintained by the National Library of Medicine. NCT01369199 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.