Trial · NCT00311766
A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa
NCT00311766, Phase 2, Terminated, RegeneRx Biopharmaceuticals, Inc.; results first posted 2013-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa. Trials, record NCT00311766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00311766
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa
- NCT number
- NCT00311766
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- RegeneRx Biopharmaceuticals, Inc.
- Conditions
- Epidermolysis Bullosa
- Interventions
- Thymosin Beta 4, Placebo
- First posted
- 2006-04-06
- Last updated
- 2014-05-12
- Results first posted
- 2013-06-10
- Limitations and caveats
Early termination of the study leading to randomizing 30 of the 36 participants planned. This was due to the small pool of participants and therefore resulting in low availability of eligible participants.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 70 days | |
| Secondary | Number of Participants Whose Wounds Have Healed | 56 days | Wound healing means that the wound has closed without any drainage |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Participants Whose Wounds Have Healed | 56 days | The population for efficacy analysis will be the Full Analysis (FA) population. The FA analysis included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded. | participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 70 days | The population for safety analysis included all patients who were randomized and received at least one dose of study medication and had at one safety parameter recorded. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Whose Wounds Have Healed | Placebo | 5 | participants | ||
| Number of Participants Whose Wounds Have Healed | Thymosin Beta 4 | 8 | participants | ||
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | Adverse Events | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Thymosin Beta 4 | Adverse Events | 1 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | Serious Adverse Events | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Thymosin Beta 4 | Serious Adverse Events | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | STARTED | Thymosin Beta 4 | 22 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | COMPLETED | Thymosin Beta 4 | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Thymosin Beta 4 | 5 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | cellulitis | Infections and infestations | Placebo | 0 | 8 | 0 |
| other | cellulitis | Infections and infestations | Thymosin Beta 4 | 1 | 22 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Thymosin Beta 4 | ||
| Total, other adverse events | Placebo | 0 | 8 |
| Total, other adverse events | Thymosin Beta 4 | 1 | 22 |
| Total, serious adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Thymosin Beta 4 | 0 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Thymosin Beta 4 vs Placebo: Number of Participants Whose Wounds Have Healed | Trial comparisons |
| Thymosin Beta 4 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00311766
GET https://conductscience.org/api/trials/v1/NCT00311766/registered