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

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

Study Overview

• Status: Completed
• Conditions: Venous Stasis Ulcers
• Intervention / Treatment: Drug: Thymosin Beta 4; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • Chirurgia Vascolare
  • Naples, Italy
    • Università degli Studi di Napoli - Federico II
  • Padova, Italy
    • Azienda Ospedaliera di Padova
  • Padova, Italy
    • Unità Operativa di Angiologia Azienda Ospedaliera di Padova
  • Rome, Italy
    • Istituto Dermopatico dell'Immacolata (IDI)
• Poland
  • Lublin, Poland
    • Klinika Chirurgii Naczyń i Angiologii
  • Szczecin, Poland
    • Klinika Chirurgii Ogólnej i Naczyniowej,
  • Wrocław, Poland
    • Oddział Angiologiczny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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: Tβ4; RGN-137 (topical gel)
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days	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	Up to 84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers	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	Up to 84 days

Collaborators and Investigators

• Sponsor: RegeneRx Biopharmaceuticals, Inc.
• Collaborators: sigma-tau i.f.r. S.p.A.
• Investigators: Principal Investigator: Giorgio Guarnera, MD, Istituto Dermopatico Dell'Immacolata, Rome , Italy

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: January 28, 2009
• First Submitted That Met QC Criteria: January 28, 2009
• First Posted (Estimate): January 29, 2009

Study Record Updates

• Last Update Posted (Estimate): March 30, 2010
• Last Update Submitted That Met QC Criteria: March 24, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Venous Stasis Ulcers; venous insufficiency; leg ulcers; Thymosin Beta 4; Laminin-5
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer
• Other Study ID Numbers: SSVS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No