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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

Short name SSVS

NCTNCT00832091 (opens ClinicalTrials.gov in a new tab)Other idSSVS
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
72 participants (actual)
Sponsor
RegeneRx Biopharmaceuticals, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
2 countries

Italy, Poland

Start
Jul 2006
Primary completion
Jan 2009
Completion
Jan 2009
First posted
29 Jan 2009 (estimated)
Last update posted
30 Mar 2010 (estimated)
Conditions
Venous Stasis Ulcers

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062007200820092010
  1. Ph 2

    SSVS

    NCT00832091

    Jul 2006 to Jan 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Thymosin Beta 4Drug
  • PlaceboDrug

Arms2

  • 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

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry 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

Secondary outcomes(1)

  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

    Time frame · Up to 84 days

    Registry 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Up to 84 days

Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days

GroupValue (SAEs and AEs)
Placebo24
Thymosin Beta 4 (Tβ4) at 3 Doses104
Secondary and other outcome results(1)
Secondary outcomeNumber· Up to 84 days

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

GroupValue (Participants)
Placebo4
Thymosin Beta 4 (Tβ4) at 3 Doses12

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)–1 / 1711 / 17
Thymosin Beta 4 (Tβ4) at 3 Doses0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w–3 / 5535 / 55

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 79 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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