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

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ClinicalTrials.gov Identifier: NCT00832091
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : March 24, 2010
Last Update Posted : March 30, 2010
Sponsor:
Collaborator:
sigma-tau i.f.r. S.p.A.
Information provided by:
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 Venous Stasis Ulcers
Interventions Drug: Thymosin Beta 4
Drug: Placebo
Enrollment 72
Recruitment Details Recruitment started in 2006 and ended in 2009 using 8 sites: University Medical Center Clinics
Pre-assignment Details Prior to randomization, patients need to meet specific inclusion and exclusion criteria. There was no wash-out or run-in periods
Arm/Group Title Placebo Thymosin Beta 4 (Tβ4) at 3 Doses
Hide Arm/Group Description 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) 0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
Period Title: Overall Study
Started 17 55
Completed 12 53
Not Completed 5 2
Reason Not Completed
Adverse Event             1             1
Protocol Violation             1             0
Withdrawal by Subject             2             1
Prohibited Medication             1             0
Arm/Group Title Placebo Thymosin Beta 4 (Tβ4) at 3 Doses Total
Hide Arm/Group Description 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) 0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w Total of all reporting groups
Overall Number of Baseline Participants 17 55 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 55 participants 72 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  52.9%
39
  70.9%
48
  66.7%
>=65 years
8
  47.1%
16
  29.1%
24
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 55 participants 72 participants
Female
12
  70.6%
28
  50.9%
40
  55.6%
Male
5
  29.4%
27
  49.1%
32
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 17 participants 55 participants 72 participants
Poland 6 38 44
Italy 11 17 28
1.Primary Outcome
Title Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days
Hide Description All Treatment-Emergent (TE) Serious Adverse Events (SAEs) and Adverse Events (AEs) by treatment with Tβ4 gel at the combined 3 doses in the safety population with Venous Stasis (VS) ulcers for up to 84 days. TEAE is defined as a side effect that begins or that worsens in severity after the application of at least one dose of Tβ4 gel on the venous stasis ulcer. A pre-existing condition is not considered an AE, but if it worsens during the study, then it may be considered an AE
Time Frame Up to 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol, ITT, using LOCF
Arm/Group Title Placebo Thymosin Beta 4 (Tβ4) at 3 Doses
Hide Arm/Group Description:
0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
Overall Number of Participants Analyzed 17 55
Measure Type: Number
Unit of Measure: SAEs and AEs
24 104
2.Secondary Outcome
Title Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers
Hide Description Wound healing effectiveness of Tβ4 gel applied once daily for up to 84 days to patients expressed as the number of patients whose wound had closed without drainage at the end of the study, Day 84
Time Frame Up to 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol, Intent-to-treat (ITT), using Last Observation Carried Forward (LOCF)
Arm/Group Title Placebo Thymosin Beta 4 (Tβ4) at 3 Doses
Hide Arm/Group Description:
0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
Overall Number of Participants Analyzed 17 55
Measure Type: Number
Unit of Measure: Participants
4 12
Time Frame 99 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Thymosin Beta 4 (Tβ4) at 3 Doses
Hide Arm/Group Description 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) 0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
All-Cause Mortality
Placebo Thymosin Beta 4 (Tβ4) at 3 Doses
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Thymosin Beta 4 (Tβ4) at 3 Doses
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      3/55 (5.45%)    
Infections and infestations     
Lymphangitis * 1 [1]  1/17 (5.88%)  2 0/55 (0.00%)  0
Investigations     
Increased Transamines  1 [1]  1/17 (5.88%)  1 0/55 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Connective tissue, inflammation * 1 [1]  1/17 (5.88%)  1 2/55 (3.64%)  3
Skin and subcutaneous tissue disorders     
Skin Ulcer  1 [1]  0/17 (0.00%)  0 2/55 (3.64%)  4
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
SAE not related to TB4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Thymosin Beta 4 (Tβ4) at 3 Doses
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/17 (64.71%)      35/55 (63.64%)    
Blood and lymphatic system disorders     
Leukocytosis  1  0/17 (0.00%)  0 1/55 (1.82%)  2
Gastrointestinal disorders     
Gingivitis  1 [1]  1/17 (5.88%)  1 0/55 (0.00%)  0
Nausea  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Periodontal disease  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Vomiting  1  0/17 (0.00%)  0 1/55 (1.82%)  1
General disorders     
Inflammation  1  1/17 (5.88%)  1 4/55 (7.27%)  5
face edema  1  1/17 (5.88%)  1 1/55 (1.82%)  1
Pain  1 [1]  1/17 (5.88%)  1 1/55 (1.82%)  2
edema peripheral  1  1/17 (5.88%)  1 0/55 (0.00%)  0
pyrexia  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Secretion Discharge  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Chest pain  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Hepatobiliary disorders     
Cholelithiasis  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Infections and infestations     
Mycobacterium ulcerans infection  1  0/17 (0.00%)  0 1/55 (1.82%)  1
bronchitis acute  1  0/17 (0.00%)  0 2/55 (3.64%)  3
cystitis  1  1/17 (5.88%)  1 0/55 (0.00%)  0
gastroenteritis  1  0/17 (0.00%)  0 1/55 (1.82%)  1
genitourinary tract infection  1  0/17 (0.00%)  0 1/55 (1.82%)  1
helicobacter gastritis  1  0/17 (0.00%)  0 1/55 (1.82%)  1
influenza  1  1/17 (5.88%)  1 0/55 (0.00%)  0
inviral infection  1  0/17 (0.00%)  0 1/55 (1.82%)  2
nasopharyngitis  1  1/17 (5.88%)  1 2/55 (3.64%)  2
pulpitis dental  1  0/17 (0.00%)  0 1/55 (1.82%)  1
upper respiratory infection  1  0/17 (0.00%)  0 3/55 (5.45%)  3
urinary tract infection  1  0/17 (0.00%)  0 3/55 (5.45%)  3
Injury, poisoning and procedural complications     
Excoriation  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Investigations     
Red blood cell sedimentation rate increased  1  0/17 (0.00%)  0 6/55 (10.91%)  6
alanine aminotransferase increased  1  0/17 (0.00%)  0 1/55 (1.82%)  1
bilirubin conjugated increased  1  0/17 (0.00%)  0 1/55 (1.82%)  1
blood calcium decreased  1  0/17 (0.00%)  0 1/55 (1.82%)  1
blood creatinine phosphokinase increased  1  1/17 (5.88%)  1 3/55 (5.45%)  3
blood potassium increased  1  1/17 (5.88%)  1 0/55 (0.00%)  0
body temperature increased  1  1/17 (5.88%)  1 0/55 (0.00%)  0
in urine protein/creatinine ratio increased  1  0/17 (0.00%)  0 1/55 (1.82%)  1
platelet count increased  1  1/17 (5.88%)  1 0/55 (0.00%)  0
red blood cell count increased  1  0/17 (0.00%)  0 1/55 (1.82%)  1
urinary sediment present  1  0/17 (0.00%)  0 1/55 (1.82%)  1
white blood cell count decreased  1  0/17 (0.00%)  0 1/55 (1.82%)  1
white blood cell increased  1  0/17 (0.00%)  0 2/55 (3.64%)  2
white blood cell urine positive  1  0/17 (0.00%)  0 2/55 (3.64%)  2
Metabolism and nutrition disorders     
Hypercholesteroloemia  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Hypocalcaemia  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Musculoskeletal and connective tissue disorders     
Pain in extremities  1  1/17 (5.88%)  1 3/55 (5.45%)  3
Arthropathy  1  1/17 (5.88%)  1 0/55 (0.00%)  0
Back Pain  1  1/17 (5.88%)  1 0/55 (0.00%)  0
Intervertebral disc disorder  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Osteoarthritis  1 [1]  0/17 (0.00%)  0 1/55 (1.82%)  1
Nervous system disorders     
Carpal tunnel syndrome  1 [2]  0/17 (0.00%)  0 1/55 (1.82%)  1
Psychiatric disorders     
Depression  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Renal and urinary disorders     
Renal Failure  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal Pain  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Skin and subcutaneous tissue disorders     
Pruritus  1  1/17 (5.88%)  1 4/55 (7.27%)  4
erythema  1  0/17 (0.00%)  0 3/55 (5.45%)  5
rash  1  0/17 (0.00%)  0 2/55 (3.64%)  2
dermatitis  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Dermatitis allergic  1 [1]  0/17 (0.00%)  0 1/55 (1.82%)  1
Dermatitis contact  1 [3]  1/17 (5.88%)  1 0/55 (0.00%)  0
Eczema  1 [1]  0/17 (0.00%)  0 1/55 (1.82%)  1
rash erythematous  1 [1]  0/17 (0.00%)  0 1/55 (1.82%)  1
Skin necrosis  1 [4]  0/17 (0.00%)  0 1/55 (1.82%)  1
venous ulcer pain  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Surgical and medical procedures     
Tooth extraction  1 [5]  0/17 (0.00%)  0 1/55 (1.82%)  1
Vascular disorders     
Varicose ulceration  1  1/17 (5.88%)  1 2/55 (3.64%)  4
Hypertension  1  0/17 (0.00%)  0 1/55 (1.82%)  1
Phlebitis  1  0/17 (0.00%)  0 1/55 (1.82%)  2
Thrombophlebitis  1  1/17 (5.88%)  1 0/55 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
AE not related to TB4
[2]
AE not associated with TB4
[3]
AE nnot related to TB4
[4]
AE nt related to TB4
[5]
AE unrelated to TB4
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.
RegeneRx/Sigma-Tau agreements may vary with individual investigators, but will not prohibit any investigator from publishing. RegeneRx/Sigma-Tau support the publication of results from all centers of a multi-center trial but requests that reports based on a single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nabila Turjman, PhD, Executive Director, Regulatory Affairs
Organization: RegeneRx Biopharmaceuticals, Inc.
Phone: 301-208-9191 ext 108
EMail: nturjman@regenerx.com
Layout table for additonal information
Responsible Party: Dr Giorgio Guarnera, Istituto Dermopatico dell'Immacolata (IDI), Rome, ITaly
ClinicalTrials.gov Identifier: NCT00832091     History of Changes
Other Study ID Numbers: SSVS
First Submitted: January 28, 2009
First Posted: January 29, 2009
Results First Submitted: January 19, 2010
Results First Posted: March 24, 2010
Last Update Posted: March 30, 2010