Trial Outcomes & Findings for Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB) (NCT NCT00587223)

NCT ID: NCT00587223

Last Updated: 2010-06-29

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

Through 12 weeks

Results posted on

2010-06-29

Participant Flow

Subjects were recruited from US hospital-based clinics. Recruitment was from December 2007 to December 2008.

A screening period of 1 week was utilized in the study design prior to randomization of study lesions to Apligraf or control at Day 0.

Participant milestones

Participant milestones
Measure	Apligraf Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Apligraf Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
Overall Study Adverse Event	1

Baseline Characteristics

Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apligraf/Control n=1 Participants Apligraf (a living bilayered cell therapy product) Control (a primary nonadherent dressing, nonstick gauze, retainer dressing)
Age, Categorical <=18 years	1 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

PRIMARY outcome

Timeframe: Through 12 weeks

Population: no analysis performed as only 1 subject enrolled

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through 12 weeks

Population: no analysis performed as only 1 subject enrolled

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through 12 weeks

Population: no analysis performed as only 1 subject enrolled

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through 12 months

Population: no analysis performed as only 1 subject enrolled

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through 12 weeks

Population: no analysis performed as only 1 subject enrolled

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through 12 months

Population: There was only 1 enrolled subject in the study; this endpoint was descriptively reported, no statistical analyses were performed.

Outcome measures

Outcome data not reported

Adverse Events

Apligraf

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Apligraf n=1 participants at risk Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
General disorders Fever	100.0% 1/1 • Number of events 1 • December 2007 through August 2008
Infections and infestations Wound Infection (signs and symptoms)	100.0% 1/1 • Number of events 2 • December 2007 through August 2008

Additional Information

Director of Clinical Operations

Organogenesis Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Before publishing PI shall submit copies of any proposed publication/presentation to Sponsor for review at least 30 days in advance of submission. Sponsor shall review the data provided in proposed publication against the Study database for consistency. Sponsor reserves right to delete any Confidential Information/proprietary information of Sponsor from the proposed publication/presentation. Sponsor may extend such review period for another 90 days.
Publication restrictions are in place

Restriction type: OTHER