Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers (SSVS)

This study has been completed.
Sponsor:
Collaborator:
sigma-tau i.f.r. S.p.A.
Information provided by:
RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00832091
First received: January 28, 2009
Last updated: March 24, 2010
Last verified: March 2010
Results First Received: January 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Venous Stasis Ulcers
Interventions: Drug: Thymosin Beta 4
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment started in 2006 and ended in 2009 using 8 sites: University Medical Center Clinics

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, patients need to meet specific inclusion and exclusion criteria. There was no wash-out or run-in periods

Reporting Groups
  Description
Placebo 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
Thymosin Beta 4 (Tβ4) at 3 Doses 0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w

Participant Flow:   Overall Study
    Placebo     Thymosin Beta 4 (Tβ4) at 3 Doses  
STARTED     17     55  
COMPLETED     12     53  
NOT COMPLETED     5     2  
Adverse Event                 1                 1  
Protocol Violation                 1                 0  
Withdrawal by Subject                 2                 1  
Prohibited Medication                 1                 0  



  Baseline Characteristics
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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 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
Thymosin Beta 4 (Tβ4) at 3 Doses 0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
Total Total of all reporting groups

Baseline Measures
    Placebo     Thymosin Beta 4 (Tβ4) at 3 Doses     Total  
Number of Participants  
[units: participants]
  17     55     72  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     39     48  
>=65 years     8     16     24  
Gender  
[units: participants]
     
Female     12     28     40  
Male     5     27     32  
Region of Enrollment  
[units: participants]
     
Poland     6     38     44  
Italy     11     17     28  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days   [ Time Frame: Up to 84 days ]

2.  Secondary:   Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers   [ Time Frame: Up to 84 days ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Nabila Turjman, PhD, Executive Director, Regulatory Affairs
Organization: RegeneRx Biopharmaceuticals, Inc.
phone: 301-208-9191 ext 108
e-mail: nturjman@regenerx.com


No publications provided


Responsible Party: Dr Giorgio Guarnera, Istituto Dermopatico dell'Immacolata (IDI), Rome, ITaly
ClinicalTrials.gov Identifier: NCT00832091     History of Changes
Other Study ID Numbers: SSVS
Study First Received: January 28, 2009
Results First Received: January 19, 2010
Last Updated: March 24, 2010
Health Authority: United States: Food and Drug Administration