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NCT01538862 · ClinicalTrials.gov registry record · Phase 2

Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa

A Phase 2 study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
Phase 2
Development phase
7
Enrollment target

NCT01538862: Completed Phase 2 study, sponsored by Vanderbilt University Medical Center.

NCT01538862 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01538862, a Phase 2 study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
7 participants
Enrollment target

Study Summary

This is a feasibility study to see if Granulocyte Colony Stimulating Factor (GCSF) is effective as a treatment of Dystrophic Epidermolysis Bullosa (EB). Patients will receive one course of treatment with the study drug. The course will be 7 days in length. After receiving GCSF, patients will be followed at 7 and 30 days following the discontinuation of the drug. Thirty day follow up can be done via telephone communication with the patient or family.

Primary Outcome

Percent change of active blisters and in total blister/erosion counts from baseline to 7 days

Interventions

  • DRUG Granulocyte Colony Stimulating Factor (GCSF)

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2012-02
Est. Completion 2014-11
Phase Phase 2

What the finished NCT01538862 record still lists

NCT01538862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Granulocyte Colony Stimulating Factor (GCSF) is the first listed.

NCT01538862 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01538862 about?

NCT01538862 is a clinical study titled "Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa". This is a feasibility study to see if Granulocyte Colony Stimulating Factor (GCSF) is effective as a treatment of Dystrophic Epidermolysis Bullosa (EB). Patients will receive one course of treatment with the study drug. The course will be 7 days in length. After receiving GCSF, patients will be foll...

What is the current status of trial NCT01538862?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2012-02. Estimated completion is 2014-11.

What interventions are being tested in trial NCT01538862?

The interventions under investigation include: Granulocyte Colony Stimulating Factor (GCSF) (DRUG).

Who is sponsoring clinical trial NCT01538862?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01538862's enrollment target sits among peer trials

7 1996th of 2000 higher than 5 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 NCT01538862, the US trial registry maintained by the National Library of Medicine. NCT01538862 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.