ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Epidermolysis Bullosa
Interventions Drug: Thymosin Beta 4
Drug: Placebo
Enrollment 30
Recruitment Details First Patient In:22 February 2006; Last Patient In: 6 July 2010 Locations: Medical Centers
Pre-assignment Details No wash out or run-in periods in this study
Arm/Group Title Placebo Thymosin Beta 4
Hide Arm/Group Description

Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days

Placebo : Topical administration, 0.00% qd up to 56 days

Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days

Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days

Period Title: Overall Study
Started 8 22
Completed 8 17
Not Completed 0 5
Arm/Group Title Placebo Thymosin Beta 4 Total
Hide Arm/Group Description

Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days

Placebo : Topical administration, 0.00% qd up to 56 days

Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days

Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days

Total of all reporting groups
Overall Number of Baseline Participants 8 22 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 22 participants 30 participants
<=18 years
4
  50.0%
12
  54.5%
16
  53.3%
Between 18 and 65 years
4
  50.0%
10
  45.5%
14
  46.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 22 participants 30 participants
Female
2
  25.0%
8
  36.4%
10
  33.3%
Male
6
  75.0%
14
  63.6%
20
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 22 participants 30 participants
8 22 30
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame 70 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population for safety analysis included all patients who were randomized and received at least one dose of study medication and had at one safety parameter recorded.
Arm/Group Title Placebo Thymosin Beta 4
Hide Arm/Group Description:

Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days

Placebo : Topical administration, 0.00% qd up to 56 days

Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days

Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days

Overall Number of Participants Analyzed 8 22
Measure Type: Number
Unit of Measure: Participants
Adverse Events 0 1
Serious Adverse Events 0 0
2.Secondary Outcome
Title Number of Participants Whose Wounds Have Healed
Hide Description Wound healing means that the wound has closed without any drainage
Time Frame 56 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population for efficacy analysis will be the Full Analysis (FA) population. The FA analysis included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded.
Arm/Group Title Placebo Thymosin Beta 4
Hide Arm/Group Description:

Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days

Placebo : Topical administration, 0.00% qd up to 56 days

Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days

Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days

Overall Number of Participants Analyzed 8 22
Measure Type: Number
Unit of Measure: participants
5 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Thymosin Beta 4
Comments The primary population was the Full Analysis(FA)population. The FA population included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter ANCOVA
Estimated Value 0.80
Estimation Comments [Not Specified]
Time Frame Adverse Events (AEs) were collected within 70 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Thymosin Beta 4
Hide Arm/Group Description

Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days

Placebo : Topical administration, 0.00% qd up to 56 days

Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days

Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days

All-Cause Mortality
Placebo Thymosin Beta 4
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Thymosin Beta 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Thymosin Beta 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      1/22 (4.55%)    
Infections and infestations     
cellulitis * 1 [1]  0/8 (0.00%)  0 1/22 (4.55%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Cellulitis was resolved in 27 days
Early termination of the study leading to randomizing 30 of the 36 participants planned. This was due to the small pool of participants and therefore resulting in low availability of eligible participants.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Director, David R. Crockford
Organization: RegeneRx Biopharmaceuticals, Inc.
Phone: 617-285-5588
Responsible Party: RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00311766     History of Changes
Other Study ID Numbers: SSEB
0003031 ( Other Identifier: FDA Office of Orphan Product Development (OOPD) )
First Submitted: April 4, 2006
First Posted: April 6, 2006
Results First Submitted: May 22, 2013
Results First Posted: June 10, 2013
Last Update Posted: May 12, 2014