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Trial record 1 of 6 for:    RegeneRX
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A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00311766
Recruitment Status : Terminated (Lack of patient availability and expiration of study drug)
First Posted : April 6, 2006
Results First Posted : June 10, 2013
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
RegeneRx Biopharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 4, 2006
First Posted Date  ICMJE April 6, 2006
Results First Submitted Date  ICMJE May 22, 2013
Results First Posted Date  ICMJE June 10, 2013
Last Update Posted Date May 12, 2014
Study Start Date  ICMJE February 2006
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2013)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 70 days ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2013)
Number of Participants Whose Wounds Have Healed [ Time Frame: 56 days ]
Wound healing means that the wound has closed without any drainage
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa
Official Title  ICMJE 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
Brief Summary The purpose of this study is to investigate a treatment to enhance the healing of acute and chronic nonhealing cutaneous wounds, such as the erosions experienced by patients with Epidermolysis Bullosa (EB), by the known activity of thymosin beta 4 (Tβ4). Funding Source - FDA Office of Orphan Product Development (OOPD).
Detailed Description EB is a group of genetic diseases characterized by skin-blistering and lesion-formation after minor trauma to the skin. This family of disorders, most of which are inherited, range in severity from mild to the severely disabling and life-threatening. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Epidermolysis Bullosa
Intervention  ICMJE
  • Drug: Thymosin Beta 4
    Topical administration, 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days
  • Drug: Placebo
    Topical administration, 0.00% Thymosin Beta 4 gel qd up to 56 days
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo comparator gel does not contain any active drug. Topical administration of 0.0% Thymosin Beta 4 gel, once a day (qd) up to 56 days
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Topical Administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel once a day (qd) up to 56 days
    Intervention: Drug: Thymosin Beta 4
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 3, 2012)
30
Original Enrollment  ICMJE
 (submitted: April 4, 2006)
36
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00311766
Other Study ID Numbers  ICMJE SSEB
0003031 ( Other Identifier: FDA Office of Orphan Product Development (OOPD) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RegeneRx Biopharmaceuticals, Inc.
Study Sponsor  ICMJE RegeneRx Biopharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David R Crockford RegeneRx Biopharmaceuticals, Inc.
PRS Account RegeneRx Biopharmaceuticals, Inc.
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP