Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

NCT00832091 | Completed Phase 2 Results

• 1 other identifier: SSVS
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 8

Brief 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

Conditions

Venous Stasis Ulcers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers

  Up to 84 days

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

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

Interventions

Thymosin Beta 4 DRUG

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

Also known as: Tβ4, RGN-137 (topical gel)

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RegeneRx Biopharmaceuticals, Inc.: lead
• sigma-tau i.f.r. S.p.A.: collaborator

Study Sites (8)

Chirurgia Vascolare

Bologna, Italy

Location

Università degli Studi di Napoli - Federico II

Naples, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Unità Operativa di Angiologia Azienda Ospedaliera di Padova

Padua, Italy

Location

Istituto Dermopatico dell'Immacolata (IDI)

Rome, Italy

Location

Klinika Chirurgii Naczyń i Angiologii

Lublin, Poland

Location

Klinika Chirurgii Ogólnej i Naczyniowej,

Szczecin, Poland

Location

Oddział Angiologiczny

Wroclaw, Poland

Location

MeSH Terms

Conditions

Varicose Ulcer; Venous Insufficiency; Leg Ulcer

Interventions

thymosin beta(4); Gels

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Nabila Turjman, PhD, Executive Director, Regulatory Affairs
• Organization: RegeneRx Biopharmaceuticals, Inc.

nturjman@regenerx.com

301-208-9191

Study Officials

• Giorgio Guarnera, MD

  Istituto Dermopatico Dell'Immacolata, Rome , Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 29, 2009
• Study Start: July 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: March 30, 2010
• Results First Posted: March 24, 2010

Record last verified: 2010-03

Locations

IT (5); PL (3)