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
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The primary objective of this Phase 2A clinical trial is to evaluate the safety and tolerability of Thymosin Beta 4 (TB4) gel, administered topically once daily for up to 56 days, in patients with juntional and dystrophic epidermolysis bullosa. The secondary objective is to evaluate the lesion healing effectiveness of Thymosin Beta 4, administered topically once daily for up to 56 days, in patients with epidermolysis bullosa. An additional exploratory objective is to evaluate the presence of absence of antibodies to Thymosin Beta 4 administered during the study.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingIntervention(s):
- Drug: Thymosin Beta 4 Gel
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 months to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Male or female, 18 months of age or older with dystrophic EB or 2 years of age or older with junctional EB
- Diagnosis of junctional or dystrophic EB, confirmed by electron microscopy or immunofluorescence antigenic mapping
- At least one active, unroofed EB erosion on the limb or on the trunk
- Lesion size 5 to 50 cm2, inclusive. If there is a distance less than 5 cm between the index lesion and any other active lesion (satellite lesion), the surface area of the combined lesions must be within 5 to 50 cm2, inclusive. The index lesion must be at least 5 cm2.
- Stable lesion present 14-60 days before enrollment.
- Stable lesion present from 1 to 60 days.
- More than one family member can be enrolled as long as that member is treated in a different cohort with an assurance that the drug medication will not be shared.
- No clinically significant abnormalities on Screening laboratory tests, except for the following specific laboratory thresholds: albumin must be 2 g/dL or higher, hemoglobin must be 8 g/dL or higher.
Key Exclusion Criteria:
- Any form of EB other than those specified in Inclusion 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 of topical steroidal therapy within the 30 days before enrollment. Inhaled steroids are allowed.
- Use of systemic antibiotics within the 7 days before enrollment.
- History of adverse reaction to any ingredients of the study medication.
- Neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the patient's participation in or completion of the study
- Current or former malignancy
- Arterial of venous disorder resulting in ulcerated wounds
- Diabetes mellitus
- Pregnancy or breastfeeding during the study
- Girls or women who have had menarche but have not completed menopause (1 year or longer without a menstrual period), have not been surgically sterilized, do not have a partner with documented sterility, and are not using adequate contraception. (Only combined hormonal methods of contraception or sexual abstinence are acceptable methods of contraception for this study).
- Any condition or situation likely to cause the patient to be unable or unwilling to participate in study procedures or participate in all scheduled study assessments.
- Previous participation in this study
- Family member already enrolled in study (except as described above).
Additional Study Details
Official Title:
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 BullosaAnticipated start date:
11/8/2005Lead Sponsor:
RegeneRx Biopharmaceuticals, Inc.Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Safety and tolerability of TB4 gel
Secondary Outcomes:
- Evaluate lesion healing effectiveness of TB4
- Evaluate presence of absence of antibodies to TB4
Total Number to be Enrolled:
36Total Number to be Enrolled at Stanford:
6More Information
Secondary ID(s):
- eProtocol #: 3542
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/30/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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