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

January 28, 2009
March 24, 2010
July 2006
January 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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
Safety and tolerability of TB4,administered topically qd, for up to 84 days in patients with Venous Stasis ulcers [ Time Frame: up tp 84 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00832091 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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
Wound healing effectiveness of Tβ4, administered topically qd for up to 84 days, in patients with Venous Stasis ulcers [ Time Frame: Up to 84 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients With Venous Stasis Ulcers

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers

The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Venous Stasis (VS) ulcers. VS ulcers develop on the ankle or lower leg in patients with chronic vascular disease. In these patients, blood flow in the lower extremities is impaired, leading to edema (swelling) and mild redness and scaling of the skin that gradually progress to ulceration. Tβ4 is a synthetically-produced copy of a naturally occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Venous Stasis Ulcers
  • Drug: Thymosin Beta 4
    There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days
    Other Names:
    • Thymosin beta 4
    • Tβ4
    • RGN-137 (topical gel)
  • Drug: Placebo
    There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days
  • Active Comparator: 1
    There are 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were 3 concentrations used for topical administration to the active drug groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days
    Intervention: Drug: Thymosin Beta 4
  • Placebo Comparator: 2
    There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed Consent Form signed by the patient
  • Male or female, between 18 and 79 years of age
  • At least one venous leg ulceration stable for at least 6 weeks before enrollment
  • Surface area between 3 and 30 cm2

Exclusion Criteria:

  • Have clinical evidence of active infection on the index ulcer
  • Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment
  • Use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment
  • History of adverse reaction to any ingredients of the study medication
  • Clinically significant neurological, cardiovascular, respiratory, hepatic, renal, metabolic and dermatologic disease other than venous ulcers
  • Current or former malignancy
  • Arterial disorder resulting in ulcerated ulcers
  • Diabetes mellitus
  • Pregnant or lactating (breastfeeding) women. A serum pregnancy test will be performed at screening for female patients of childbearing potential
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Poland
 
NCT00832091
SSVS
No
Dr Giorgio Guarnera, Istituto Dermopatico dell'Immacolata (IDI), Rome, ITaly
RegeneRx Biopharmaceuticals, Inc.
sigma-tau i.f.r. S.p.A.
Principal Investigator: Giorgio Guarnera, MD Istituto Dermopatico Dell'Immacolata, Rome , Italy
RegeneRx Biopharmaceuticals, Inc.
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP