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NCT00606086 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection

A Phase 2 study, sponsored by GlobeImmune.

Completed
Registry status
Phase 2
Development phase
140
Enrollment target

NCT00606086: Completed Phase 2 study, sponsored by GlobeImmune.

NCT00606086 is a Phase 2 study that has completed, run by GlobeImmune. The registered enrollment target is 140 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00606086, a Phase 2 study, has completed, sponsored by GlobeImmune.

COMPLETED
Registry status
Phase 2
Development phase
140 participants
Enrollment target

Study Summary

The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections including EVR, ETR, and SVR.

Primary Outcome

Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.

Interventions

  • DRUG GI-5005
  • DRUG Pegylated Interferon and Ribavirin

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2007-12
Est. Completion 2012-11
Phase Phase 2
GlobeImmune

4 total trials

What the finished NCT00606086 record still lists

NCT00606086 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which GI-5005 is the first listed.

NCT00606086 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00606086 about?

NCT00606086 is a clinical study titled "Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection". The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections including EVR, ETR, and SVR.

What is the current status of trial NCT00606086?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2007-12. Estimated completion is 2012-11.

What interventions are being tested in trial NCT00606086?

The interventions under investigation include: GI-5005 (DRUG), Pegylated Interferon and Ribavirin (DRUG).

Who is sponsoring clinical trial NCT00606086?

This trial is sponsored by GlobeImmune, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00606086's enrollment target sits among peer trials

140 512th of 2000 higher than 1,476 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00606086, the US trial registry maintained by the National Library of Medicine. NCT00606086 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.