Trial Outcomes & Findings for A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa (NCT NCT00311766)

NCT ID: NCT00311766

Last Updated: 2014-05-12

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: 70 days
• Results posted on: 2014-05-12

Participant Flow

First Patient In:22 February 2006; Last Patient In: 6 July 2010 Locations: Medical Centers

No wash out or run-in periods in this study

Participant milestones

Measure	Placebo Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days Placebo : Topical administration, 0.00% qd up to 56 days	Thymosin Beta 4 Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days
Overall Study STARTED	8	22
Overall Study COMPLETED	8	17
Overall Study NOT COMPLETED	0	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa

Baseline characteristics by cohort

Measure	Placebo n=8 Participants Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days Placebo : Topical administration, 0.00% qd up to 56 days	Thymosin Beta 4 n=22 Participants Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	22 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 70 days

Population: 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.

Outcome measures

Measure	Placebo n=8 Participants Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days Placebo : Topical administration, 0.00% qd up to 56 days	Thymosin Beta 4 n=22 Participants Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse Events	0 Participants	1 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 56 days

Population: 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.

Wound healing means that the wound has closed without any drainage

Outcome measures

Measure	Placebo n=8 Participants Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days Placebo : Topical administration, 0.00% qd up to 56 days	Thymosin Beta 4 n=22 Participants Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days
Number of Participants Whose Wounds Have Healed	5 participants	8 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Thymosin Beta 4

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=8 participants at risk Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days Placebo : Topical administration, 0.00% qd up to 56 days	Thymosin Beta 4 n=22 participants at risk Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days
Infections and infestations cellulitis	0.00% 0/8 • Adverse Events (AEs) were collected within 70 days	4.5% 1/22 • Number of events 1 • Adverse Events (AEs) were collected within 70 days

Additional Information

Study Director, David R. Crockford

RegeneRx Biopharmaceuticals, Inc.

Phone: 617-285-5588

Email: dcrockford@regenerx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60