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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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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient In:22 February 2006; Last Patient In: 6 July 2010 Locations: Medical Centers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No wash out or run-in periods in this study

Reporting Groups
  Description
Placebo

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

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

Thymosin Beta 4

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


Participant Flow:   Overall Study
    Placebo   Thymosin Beta 4
STARTED   8   22 
COMPLETED   8   17 
NOT COMPLETED   0   5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

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

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

Thymosin Beta 4

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 Total of all reporting groups

Baseline Measures
   Placebo   Thymosin Beta 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   22   30 
Age 
[Units: Participants]
     
<=18 years   4   12   16 
Between 18 and 65 years   4   10   14 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   2   8   10 
Male   6   14   20 
Region of Enrollment 
[Units: Participants]
     
United States   8   22   30 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: 70 days ]

2.  Secondary:   Number of Participants Whose Wounds Have Healed   [ Time Frame: 56 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: dcrockford@regenerx.com



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