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

Primary Purpose

Venous Stasis Ulcers

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Thymosin Beta 4
Placebo
Sponsored by
RegeneRx Biopharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Stasis Ulcers focused on measuring Venous Stasis Ulcers, venous insufficiency, leg ulcers, Thymosin Beta 4, Laminin-5

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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
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

Full Information

First Posted
January 28, 2009
Last Updated
March 24, 2010
Sponsor
RegeneRx Biopharmaceuticals, Inc.
Collaborators
sigma-tau i.f.r. S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00832091
Brief Title
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
RegeneRx Biopharmaceuticals, Inc.
Collaborators
sigma-tau i.f.r. S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Stasis Ulcers
Keywords
Venous Stasis Ulcers, venous insufficiency, leg ulcers, Thymosin Beta 4, Laminin-5

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Thymosin Beta 4
Other Intervention Name(s)
Tβ4, RGN-137 (topical gel)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days
Description
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
Time Frame
Up to 84 days
Secondary Outcome Measure Information:
Title
Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers
Description
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
Time Frame
Up to 84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio Guarnera, MD
Organizational Affiliation
Istituto Dermopatico Dell'Immacolata, Rome , Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chirurgia Vascolare
City
Bologna
Country
Italy
Facility Name
Università degli Studi di Napoli - Federico II
City
Naples
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
Unità Operativa di Angiologia Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
Istituto Dermopatico dell'Immacolata (IDI)
City
Rome
Country
Italy
Facility Name
Klinika Chirurgii Naczyń i Angiologii
City
Lublin
Country
Poland
Facility Name
Klinika Chirurgii Ogólnej i Naczyniowej,
City
Szczecin
Country
Poland
Facility Name
Oddział Angiologiczny
City
Wrocław
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

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