Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

Venous Stasis Ulcers Clinical Trial

— SSVS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832091
• Other study ID #: SSVS
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2009
• Last updated: March 24, 2010
• Start date: July 2006
• Est. completion date: January 2009

Study information

• Verified date: March 2010
• Source: RegeneRx Biopharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcers

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	Chirurgia Vascolare	Bologna
Italy	Università degli Studi di Napoli - Federico II	Naples
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Unità Operativa di Angiologia Azienda Ospedaliera di Padova	Padova
Italy	Istituto Dermopatico dell'Immacolata (IDI)	Rome
Poland	Klinika Chirurgii Naczyn i Angiologii	Lublin
Poland	Klinika Chirurgii Ogólnej i Naczyniowej,	Szczecin
Poland	Oddzial Angiologiczny	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
RegeneRx Biopharmaceuticals, Inc.	sigma-tau i.f.r. S.p.A.

Countries where clinical trial is conducted

Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of Thymosin Beta 4 (Tß4) 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 Tß4 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 Tß4 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	Yes
Secondary	Wound Healing (Wound Closure Without Drainage) by Applying Tß4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers	Wound healing effectiveness of Tß4 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	No