Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers - Full Text View

Purpose

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

Condition	Intervention	Phase
Venous Stasis Ulcers	Drug: Thymosin Beta 4 Drug: Placebo	Phase 2

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

Further study details as provided by RegeneRx Biopharmaceuticals, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	72
Study Start Date:	July 2006
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: Thymosin beta 4 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

Arms

Assigned Interventions

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:

Thymosin beta 4
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832091

Locations

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

Sponsors and Collaborators

RegeneRx Biopharmaceuticals, Inc.

sigma-tau i.f.r. S.p.A.

Investigators

Principal Investigator:

Giorgio Guarnera, MD

Istituto Dermopatico Dell'Immacolata, Rome , Italy

More Information

No publications provided

Responsible Party:	Dr Giorgio Guarnera, Istituto Dermopatico dell'Immacolata (IDI), Rome, ITaly
ClinicalTrials.gov Identifier:	NCT00832091 History of Changes
Other Study ID Numbers:	SSVS
Study First Received:	January 28, 2009
Results First Received:	January 19, 2010
Last Updated:	March 24, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by RegeneRx Biopharmaceuticals, Inc.:

Venous Stasis Ulcers
venous insufficiency
leg ulcers
Thymosin Beta 4
Laminin-5

Additional relevant MeSH terms:

Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Ulcer
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency

Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013

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