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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00311766 |
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Date of registration:
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04/04/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients With Epidermolysis Bullosa |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00311766 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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David R Crockford |
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Address:
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Telephone:
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Email:
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Affiliation:
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RegeneRx Biopharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Informed Consent form signed by the patient or patient's legal representative; also,
if the patient is under the age of majority but capable of providing assent, signed
assent from the patient
- Diagnosis of junctional or dystrophic EB.
- Patients who present with Hallopeau-Siemens subtype may be enrolled.
- At least one active, unroofed EB erosion on the limb or on the trunk.
- Lesion size 5 to 50 cm2, inclusive.
- Stable lesion present for 14-60 days before enrollment.
- More that one member in a family can be enrolled as long as that member is treated to
a different cohort with an assurance that the study medication will not be shared.
- No clinically significant abnormalities (Grade 2 or higher on the National Cancer
Institute [NCI] toxicity scale) on Screening laboratory tests, except for the
following specific laboratory threshold result: albumin must be 2 g/dL or higher;
hemoglobin must be 8 g/dL or higher.
Exclusion Criteria:
- Clinical evidence of local infection of the index (targeted) lesion.
- Use of any investigational drug within the 30 days before enrollment.
- Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.
- Use of systemic or topical steroidal therapy within the 30 days before
enrollment.Inhaled steroids are allowed.
- Use of systemic antibiotics within the 7 days before enrollment.
- Current or former malignancy.
- Arterial or venous disorder resulting in ulcerated wounds.
- Diabetes mellitus.
- Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed
at Screening for female patients of childbearing potential.)
Age minimum:
2 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epidermolysis Bullosa
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Intervention(s)
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Drug: Placebo
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Drug: Thymosin Beta 4
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Primary Outcome(s)
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
[Time Frame: 70 days]
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Secondary Outcome(s)
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Number of Participants Whose Wounds Have Healed
[Time Frame: 56 days]
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Secondary ID(s)
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0003031
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SSEB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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