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
  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

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 April 16, 2014