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Trial record 2 of 11 for:    thymosin beta 4

Study of Thymosin Beta 4 in Patients With Pressure Ulcers

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: NCT00382174
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : February 1, 2010
Last Update Posted : February 1, 2010
Sponsor:
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 Pressure Ulcers
Interventions Drug: Placebo
Drug: Thymosin Beta 4
Enrollment 72
Recruitment Details Recruitment started in 2005 and ended in 2008 using 13 sites: Medical Center Clinics, Wound Care Center, Veteran Administration Centers, and Clinical Research Centers.
Pre-assignment Details Prior to randomization, patients needed to meet specific inclusion and exclusion criteria: results of pregnancy tests needed to be negative; glycosylated hemoglobin tests needed to be less or equal to 8.5% of the total hemoglobin.
Arm/Group Title Placebo Tβ4 at 3 Doses Placebo vs. Thymosin Beta 4 at 3 Doses
Hide Arm/Group Description 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
Period Title: Overall Study
Started 18 54 72
Completed 14 37 51
Not Completed 4 17 21
Reason Not Completed
Lost to Follow-up             1             4             5
Adverse Event             1             4             5
Withdrawal by Subject             1             4             5
Non compliance             1             0             1
Physician Decision             0             2             2
Failed to meet criteria             0             1             1
Wounds merged             0             2             2
Arm/Group Title Placebo Tβ4 at 3 Doses Total
Hide Arm/Group Description 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w Total of all reporting groups
Overall Number of Baseline Participants 18 54 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 54 participants 72 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  94.4%
38
  70.4%
55
  76.4%
>=65 years
1
   5.6%
16
  29.6%
17
  23.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 54 participants 72 participants
Female
2
  11.1%
14
  25.9%
16
  22.2%
Male
16
  88.9%
40
  74.1%
56
  77.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 54 participants 72 participants
18 54 72
1.Primary Outcome
Title Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days
Hide Description All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population
Time Frame Up to 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tβ4 at 3 Doses Placebo vs. Thymosin Beta 4 at 3 Doses
Hide Arm/Group Description:
0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
Overall Number of Participants Analyzed 18 54 72
Measure Type: Number
Unit of Measure: participants
18 53 71
2.Secondary Outcome
Title Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days
Hide Description Incidence of wound healing at the end of the study, Day 84
Time Frame Up to 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol,ITT, and using LOCF
Arm/Group Title Placebo Tβ4 at 3 Doses Placebo vs. Thymosin Beta 4 at 3 Doses
Hide Arm/Group Description:
0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
Overall Number of Participants Analyzed 18 54 72
Measure Type: Number
Unit of Measure: Number of healed participants
3 8 11
Time Frame Adverse Events (AEs) were collected for 99 days
Adverse Event Reporting Description AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
 
Arm/Group Title Placebo Tβ4 at 3 Doses Placebo vs. Thymosin Beta 4 at 3 Doses
Hide Arm/Group Description 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
All-Cause Mortality
Placebo Tβ4 at 3 Doses Placebo vs. Thymosin Beta 4 at 3 Doses
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Tβ4 at 3 Doses Placebo vs. Thymosin Beta 4 at 3 Doses
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5      13      18    
Blood and lymphatic system disorders       
Anaemia * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Cardiac disorders       
Angina * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Cardiac Failure Congestive * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
General disorders       
Chest pain * 1  1/18 (5.56%)  1 1/53 (1.89%)  1 2/71 (2.82%)  2
Pyrexia * 1  0/18 (0.00%)  0 3/53 (5.66%)  3 3/71 (4.23%)  3
Hepatobiliary disorders       
Cholecystitis * 1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Infections and infestations       
Bacteraemia * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Infected Skin Ulcer * 1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Infection * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Lobar pneumonia * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Osteomyelitis * 1  2/18 (11.11%)  2 1/53 (1.89%)  1 3/71 (4.23%)  3
Perianal Abscess * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Pneumonia * 1  0/18 (0.00%)  0 2/53 (3.77%)  2 2/71 (2.82%)  2
Sepsis * 1  2/18 (11.11%)  2 2/53 (3.77%)  2 4/71 (5.63%)  4
Skin infection * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Urinary Tract Infection * 1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Urosepsis * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Wound Infection staphylococcal * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Injury, poisoning and procedural complications       
Overdose * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Wound Complications * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Investigations       
Heart Rate Increased * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Psychiatric disorders       
Affective Disorder * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Confusional State * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Respiratory, thoracic and mediastinal disorders       
Acute Respiratory Failure * 1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Pulmonary Embolism * 1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Tβ4 at 3 Doses Placebo vs. Thymosin Beta 4 at 3 Doses
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13      40      53    
Blood and lymphatic system disorders       
Aneamia  1  0/18 (0.00%)  0 2/53 (3.77%)  2 2/71 (2.82%)  2
Cardiac disorders       
Angina Pectoris  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Cardiac Failure Congestive  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Endocrine disorders       
Hyperaldosteronism  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Eye disorders       
Adreanal Insufficiency  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Conjunctivitis  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Gastrointestinal disorders       
Dental Caries  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Diarrhea  1  0/18 (0.00%)  0 2/53 (3.77%)  2 2/71 (2.82%)  2
Nausea  1  0/18 (0.00%)  0 3/53 (5.66%)  3 3/71 (4.23%)  3
Vomiting  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
General disorders       
Asthenia  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Chest Pain  1  1/18 (5.56%)  1 1/53 (1.89%)  1 1/71 (1.41%)  1
Chills  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Inflammation  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Oedema Peripheral  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Pyrexia  1  1/18 (5.56%)  1 8/53 (15.09%)  8 9/71 (12.68%)  9
Hepatobiliary disorders       
Cholecystitis  1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Immune system disorders       
Hypersensitivity  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Infections and infestations       
Abscess  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Bacteraemia  1  0/18 (0.00%)  0 2/53 (3.77%)  2 2/71 (2.82%)  2
Bacterial Infection  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Beta Haemolytic Streptococcal Infection  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Candidiasis  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Catheter Related Infection  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Catheter Site Infection  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Clostridium Difficile Colitis  1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Fungal Infection  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Infected Skin Ulcer  1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Infection  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Lobar Pneumonia  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Nasopharyngitis  1  0/18 (0.00%)  0 2/53 (3.77%)  2 2/71 (2.82%)  2
Oral Candidiasis  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Osteomyelitis  1  2/18 (11.11%)  2 2/53 (3.77%)  2 4/71 (5.63%)  4
Otitis Media  1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Perianal Abscess  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Pneumonia  1  0/18 (0.00%)  0 3/53 (5.66%)  3 3/71 (4.23%)  3
Sepsis  1  2/18 (11.11%)  2 5/53 (9.43%)  5 7/71 (9.86%)  7
Skin Infection  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Staphylococcal Infection  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Upper Respiratory Tract Infection  1  1/18 (5.56%)  1 2/53 (3.77%)  2 3/71 (4.23%)  3
Urinary Tract Infection  1  4/18 (22.22%)  4 9/53 (16.98%)  9 13/71 (18.31%)  13
Urosepsis  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Vaginal Infection  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Wound Infection  1  0/18 (0.00%)  0 3/53 (5.66%)  3 3/71 (4.23%)  3
Wound Infection Staphylococcal  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Injury, poisoning and procedural complications       
Arteriovenous Fistula Site Complication  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Excoriation  1  0/18 (0.00%)  0 2/53 (3.77%)  2 2/71 (2.82%)  2
Joint Injury  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Overdose  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Post Procedural Haemorrhage  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Procedural Pain  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Thermal Burn  1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Wound  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Wound Complication  1  1/18 (5.56%)  1 4/53 (7.55%)  4 5/71 (7.04%)  5
Wound Secretion  1  0/18 (0.00%)  0 2/53 (3.77%)  2 2/71 (2.82%)  2
Investigations       
Blood Albumin Decreased  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Blood Cholesterol Decreased  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Blood Potassium Decreased  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Haematocrit Decreased  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Haemoglobin Decreased  1  1/18 (5.56%)  1 1/53 (1.89%)  1 2/71 (2.82%)  2
Heart Rate Increased  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Oxygen Saturation Abnormal  1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Metabolism and nutrition disorders       
Dehydration  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Diabetes Mellitus  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Hyperkalaemia  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Hypokalaemia  1  0/18 (0.00%)  0 2/53 (3.77%)  2 2/71 (2.82%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/18 (0.00%)  0 2/53 (3.77%)  2 2/71 (2.82%)  2
Nervous system disorders       
Headache  1  0/18 (0.00%)  0 2/53 (3.77%)  2 2/71 (2.82%)  2
Muscle Spasticity  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Psychiatric disorders       
Affective Disorder  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Anxiety  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Confusional State  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Depression  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Reproductive system and breast disorders       
Epididymitis  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Respiratory, thoracic and mediastinal disorders       
Acute Respiratory Failure  1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Atelectasis  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Hiccups  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Pharyngolaryngeal Pain  1  1/18 (5.56%)  1 3/53 (5.66%)  3 4/71 (5.63%)  4
Pulmonary Embolism  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Respiratory Arrest  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Skin and subcutaneous tissue disorders       
Decubitus Ulcer  1  1/18 (5.56%)  1 1/53 (1.89%)  1 2/71 (2.82%)  2
Ecchymosis  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Erythema  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Pruritus  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Rash  1  0/18 (0.00%)  0 2/53 (3.77%)  2 2/71 (2.82%)  2
Skin Burning Sensation  1  1/18 (5.56%)  1 0/53 (0.00%)  0 1/71 (1.41%)  1
Skin Maceration  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Skin Necrosis  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Skin Ulcer  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Surgical and medical procedures       
Tooth Extraction  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Vascular disorders       
Hypotension  1  0/18 (0.00%)  0 1/53 (1.89%)  1 1/71 (1.41%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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 (RGN) agreements may vary with individual PIs, but will not prohibit any PI from publishing. RGN supports the publication of results from all centers of a multi-center trial but requests that reports based on 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: 301-280-1992 ext 108
EMail: nturjman@regenerx.com
Layout table for additonal information
Responsible Party: David Crockford, VP, Clinical and Regulatory Affairs, RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00382174     History of Changes
Other Study ID Numbers: SSPU
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: December 29, 2009
Results First Posted: February 1, 2010
Last Update Posted: February 1, 2010