Trial Outcomes & Findings for Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers (NCT NCT00832091)
NCT ID: NCT00832091
Last Updated: 2010-03-30
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Up to 84 days
Results posted on
2010-03-30
Participant Flow
Recruitment started in 2006 and ended in 2009 using 8 sites: University Medical Center Clinics
Prior to randomization, patients need to meet specific inclusion and exclusion criteria. There was no wash-out or run-in periods
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
55
|
|
Overall Study
COMPLETED
|
12
|
53
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Prohibited Medication
|
1
|
0
|
Baseline Characteristics
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
Baseline characteristics by cohort
| Measure |
Placebo
n=17 Participants
0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
|
Thymosin Beta 4 (Tβ4) at 3 Doses
n=55 Participants
0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
6 participants
n=5 Participants
|
38 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=5 Participants
|
17 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 84 daysPopulation: Analysis per protocol, ITT, using LOCF
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
Outcome measures
| Measure |
Placebo
n=17 Participants
0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
|
Thymosin Beta 4 (Tβ4) at 3 Doses
n=55 Participants
0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
|
|---|---|---|
|
Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days
|
24 SAEs and AEs
|
104 SAEs and AEs
|
SECONDARY outcome
Timeframe: Up to 84 daysPopulation: Analysis per protocol, Intent-to-treat (ITT), using Last Observation Carried Forward (LOCF)
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
Outcome measures
| Measure |
Placebo
n=17 Participants
0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
|
Thymosin Beta 4 (Tβ4) at 3 Doses
n=55 Participants
0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
|
|---|---|---|
|
Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers
|
4 Participants
|
12 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Thymosin Beta 4 (Tβ4) at 3 Doses
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=17 participants at risk
0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
|
Thymosin Beta 4 (Tβ4) at 3 Doses
n=55 participants at risk
0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Connective tissue, inflammation
|
5.9%
1/17 • Number of events 1 • 99 days
|
3.6%
2/55 • Number of events 3 • 99 days
|
|
Investigations
Increased Transamines
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
Infections and infestations
Lymphangitis
|
5.9%
1/17 • Number of events 2 • 99 days
|
0.00%
0/55 • 99 days
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/17 • 99 days
|
3.6%
2/55 • Number of events 4 • 99 days
|
Other adverse events
| Measure |
Placebo
n=17 participants at risk
0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
|
Thymosin Beta 4 (Tβ4) at 3 Doses
n=55 participants at risk
0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
|
|---|---|---|
|
Infections and infestations
Mycobacterium ulcerans infection
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/17 • 99 days
|
10.9%
6/55 • Number of events 6 • 99 days
|
|
Investigations
alanine aminotransferase increased
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Investigations
bilirubin conjugated increased
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Investigations
blood calcium decreased
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Investigations
blood creatinine phosphokinase increased
|
5.9%
1/17 • Number of events 1 • 99 days
|
5.5%
3/55 • Number of events 3 • 99 days
|
|
Investigations
blood potassium increased
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
Investigations
body temperature increased
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
Infections and infestations
bronchitis acute
|
0.00%
0/17 • 99 days
|
3.6%
2/55 • Number of events 3 • 99 days
|
|
Infections and infestations
cystitis
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Infections and infestations
genitourinary tract infection
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Infections and infestations
helicobacter gastritis
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Investigations
in urine protein/creatinine ratio increased
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Infections and infestations
influenza
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
Infections and infestations
inviral infection
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 2 • 99 days
|
|
Infections and infestations
nasopharyngitis
|
5.9%
1/17 • Number of events 1 • 99 days
|
3.6%
2/55 • Number of events 2 • 99 days
|
|
Investigations
platelet count increased
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
Infections and infestations
pulpitis dental
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Investigations
red blood cell count increased
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Infections and infestations
upper respiratory infection
|
0.00%
0/17 • 99 days
|
5.5%
3/55 • Number of events 3 • 99 days
|
|
Investigations
urinary sediment present
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/17 • 99 days
|
5.5%
3/55 • Number of events 3 • 99 days
|
|
Investigations
white blood cell count decreased
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Investigations
white blood cell increased
|
0.00%
0/17 • 99 days
|
3.6%
2/55 • Number of events 2 • 99 days
|
|
Investigations
white blood cell urine positive
|
0.00%
0/17 • 99 days
|
3.6%
2/55 • Number of events 2 • 99 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 1 • 99 days
|
7.3%
4/55 • Number of events 4 • 99 days
|
|
Skin and subcutaneous tissue disorders
erythema
|
0.00%
0/17 • 99 days
|
5.5%
3/55 • Number of events 5 • 99 days
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/17 • 99 days
|
3.6%
2/55 • Number of events 2 • 99 days
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Skin and subcutaneous tissue disorders
rash erythematous
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Skin and subcutaneous tissue disorders
venous ulcer pain
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
General disorders
Inflammation
|
5.9%
1/17 • Number of events 1 • 99 days
|
7.3%
4/55 • Number of events 5 • 99 days
|
|
General disorders
face edema
|
5.9%
1/17 • Number of events 1 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
General disorders
Pain
|
5.9%
1/17 • Number of events 1 • 99 days
|
1.8%
1/55 • Number of events 2 • 99 days
|
|
General disorders
edema peripheral
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
General disorders
pyrexia
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
General disorders
Secretion Discharge
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
General disorders
Chest pain
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremities
|
5.9%
1/17 • Number of events 1 • 99 days
|
5.5%
3/55 • Number of events 3 • 99 days
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Vascular disorders
Varicose ulceration
|
5.9%
1/17 • Number of events 1 • 99 days
|
3.6%
2/55 • Number of events 4 • 99 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 2 • 99 days
|
|
Vascular disorders
Thrombophlebitis
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
Gastrointestinal disorders
Gingivitis
|
5.9%
1/17 • Number of events 1 • 99 days
|
0.00%
0/55 • 99 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Metabolism and nutrition disorders
Hypercholesteroloemia
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 2 • 99 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Psychiatric disorders
Depression
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/17 • 99 days
|
1.8%
1/55 • Number of events 1 • 99 days
|
Additional Information
Nabila Turjman, PhD, Executive Director, Regulatory Affairs
RegeneRx Biopharmaceuticals, Inc.
Phone: 301-208-9191
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER