Safety Follow-Up to HP 802-247-09-015 | NCT00900029 | Trialant
NCT00900029
Sponsor
Healthpoint
Status
Completed
Last Update Posted
Aug 2, 2017Actual
Enrollment
206Actual
Phase
Not provided
Conditions
Venous Leg Ulcer
Venous Stasis Ulcer
Interventions
No HP802 Treatment
No HP802 Vehicle Treatment
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT00900029
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
802-247-09-016
Secondary IDs
Not provided
Brief Title
Safety Follow-Up to HP 802-247-09-015
Official Title
A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015
Acronym
Not provided
Organization
HealthpointINDUSTRY
Status Module
Record Verification Date
Sep 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2009
Primary Completion Date
Oct 2011Actual
Completion Date
Jan 2012Actual
First Submitted Date
May 11, 2009
First Submission Date that Met QC Criteria
May 11, 2009
First Posted Date
May 12, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 28, 2016
Results First Submitted that Met QC Criteria
Sep 28, 2016
Results First Posted Date
Sep 29, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 27, 2017
Last Update Posted Date
Aug 2, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
HealthpointINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a 24-week observational follow safety study for Study 802-247-09-015.
Detailed Description
The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.
Conditions Module
Conditions
Venous Leg Ulcer
Venous Stasis Ulcer
Keywords
Venous Leg Ulcer
Venous Stasis Ulcer
VLU
VSU
Leg Ulcer
Leg Wound
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
206Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
No HP802 Treatment
Treatment received in Study 802-247-09-015 was HP802
Biological: No HP802 Treatment
No HP802 Vehicle Treatment
Treatment received in Study 802-247-09-015 was HP802 Vehicle
Other: No HP802 Vehicle Treatment
Interventions
Name
Type
Description
Arm Group Labels
Other Names
No HP802 Treatment
Biological
No HP802 Treatment
No HP802 Vehicle Treatment
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
The Number of Participants With Closed Target Ulcers at Each Visit
At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
Over the 24-week study period, at each of the bi-monthly visits
Number of Subjects With Target Wound Closed for the First Time During the Study Period.
At each visit the status of open target ulcers was evaluated as "remained open" or "closed".
Over the 24-week study period, at each of the bi-monthly visits
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
INCLUSION CRITERIA:
Provide informed consent
Willing to comply with protocol instructions, including allowing all study assessments.
Subject was randomized in HP 802-247-09-015 and received at least one application of a test article, whether active or placebo.
Subject has ended their participation in HP 802-247-09-015 by virtue of completing the study, or by dropping out prior to completion.
Exclusion Criteria
Subjects who refuse to provide written informed consent will be excluded from this trial.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Subjects who participated in Study No. 802-247-09-015 - "A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers" and agreed to continue with the follow-up study.
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Hebert B Slade, MD, FAAAAI
Healthpoint
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of AZ College of Medicine
Tucson
Arizona
85724
United States
Center for Clinical Research
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Both PIs and subjects remained blinded to the therapy each subject received in 802-247-09-015. No test article was administered during this study and any therapy was at the discretion of the PI, with no restrictions.
Recruitment Details
Eligible subjects were those who completed study 802-247-09-015. Of the 228 subjects who completed 802-247-09-015, 206 consented to enter this safety follow up study, between June 1, 2009 and October, 20, 2011.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LD-Q14D
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
FG001
LD-Q7D
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
3
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Not provided
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Cohort
Time Perspective
Prospective
Masking Info
No data available
No data is available for this block.
Other
No HP802 Vehicle Treatment
Castro Valley
California
94546
United States
ILD Consulting, Inc.
Encinitas
California
92024
United States
Vascular Surgery Associates
Los Angeles
California
90048
United States
UCSD Wound Treatment and Research Center
San Diego
California
92013
United States
University of Miami
Miami
Florida
33186
United States
Doctors Research Network
South Miami
Florida
33143
United States
Robert J. Snyder
Tamarac
Florida
33321
United States
Northwestern University Feinberg School of Medicine
Chicago
Illinois
60154
United States
Passavant Area Hospital
Jacksonville
Illinois
62650
United States
Rosalind Franklin University
North Chicago
Illinois
60064
United States
Southern Illinois University
Springfield
Illinois
62702
United States
Johns Hopkins Wound Center
Baltimore
Maryland
21231
United States
Boston Medical Center
Boston
Massachusetts
02118
United States
New England Sinai Hospital
Stoughton
Massachusetts
02972
United States
Advanced Foot and Ankle Center
Las Vegas
Nevada
89119
United States
Vincent Giacalone
Emerson
New Jersey
07630
United States
St. Luke's Roosevelt Hospital Center
New York
New Jersey
10025
United States
Overglook Hospital Wound Healing Program
Summit
New Jersey
07901
United States
University of North Carolina
Chapel Hill
North Carolina
27599
United States
Harrisburg Foot and Ankle Center
Harrisburg
Pennsylvania
17112
United States
Center for Advanced Wound Care
Reading
Pennsylvania
19601
United States
Arlington Research Center
Arlington
Texas
76011
United States
Wound Care Consultants
Dallas
Texas
75093
United States
Southwest Regional Wound Care Center
Lubbock
Texas
79410
United States
Peripheral Vascular Associates
San Antonio
Texas
78205
United States
Dixie Regional Medical Center's Wound Clinic
St. George
Utah
84770
United States
Lake Washington Vascular, PLLC
Bellevue
Washington
98004
United States
Providence Sacred Heart Medical Center Wound Clinic
Spokane
Washington
99204
United States
Aging Rehabilitation & Geriatric Care Research Center
London
Ontario
N6C5J1
Canada
FG002
HD-Q14D
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
FG003
HD-Q7D
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
FG004
HP802-247 Vehicle
Acellular vehicle applied weekly applied to wound surface every week
FG00038 subjects
FG00141 subjects
FG00241 subjects
FG00342 subjects
FG00444 subjects
COMPLETED
FG00035 subjects
FG00137 subjects
FG00238 subjects
FG00335 subjects
FG00438 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG0037 subjects
FG0046 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0034 subjects
FG0044 subjects
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Subjects and PIs remained blinded as treatment in the 802-247-09-015 study. There were no restrictions as to treatment by the PIs during this study. Blinding was maintained in order to assess the final outcomes of this study in relation to the therapy received in the prior study
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
HP802-247 Vehicle
Acellular vehicle applied weekly
BG001
LD-Q14D
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
BG002
LD-Q7D
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
BG003
HD-Q14D
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
BG004
HD-Q7D
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00044
BG00138
BG00241
BG00341
BG00442
BG005206
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
18-39 years
Title
Measurements
BG0001
BG0014
BG0023
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00117
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0009
BG00111
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
The Number of Participants With Closed Target Ulcers at Each Visit
At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
Subjects who completed the 802-247-09-015 study with a closed target wound attended three bimonthly visits.
Posted
Number
participants
Over the 24-week study period, at each of the bi-monthly visits
ID
Title
Description
OG000
LD-Q14D
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
OG001
LD-Q7D
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
OG002
HD-Q14D
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
OG003
HD-Q7D
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
OG004
HP802-247 Vehicle
Acellular vehicle applied weekly
Units
Counts
Participants
OG00027
OG00121
OG00225
OG003
Title
Denominators
Categories
Enrollment
Title
Measurements
OG00027
OG00121
OG00225
OG003
Primary
Number of Subjects With Target Wound Closed for the First Time During the Study Period.
At each visit the status of open target ulcers was evaluated as "remained open" or "closed".
Subjects who completed the 802-247-09-015 study with open target wound attended three bimonthly visits over the duration of the study.
Posted
Number
participants
Over the 24-week study period, at each of the bi-monthly visits
ID
Title
Description
OG000
LD-Q14D
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
OG001
LD-Q7D
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
OG002
HD-Q14D
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
OG003
HD-Q7D
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
OG004
HP802-247 Vehicle
Time Frame
The duration of the 24-week study period
Description
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
LD-Q14D
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
3
38
10
38
EG001
LD-Q7D
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
0
41
6
41
EG002
HD-Q14D
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
4
41
5
41
EG003
HD-Q7D
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
5
42
11
42
EG004
HP802-247 Vehicle
4
44
14
44
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute coronary syndrome
Cardiac disorders
MedDRA v 12.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected41 at risk
EG0031 events1 affected42 at risk
EG0040 events0 affected44 at risk
Arrhythmia
Cardiac disorders
MedDRA v 12.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected41 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v 12.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected41 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA v 12.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected41 at risk
EG003
Cardiac valve disease
Cardiac disorders
MedDRA v 12.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected41 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA v 12.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected41 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v 12.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected41 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v 12.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected41 at risk
EG003
Wound infection
Infections and infestations
MedDRA v 12.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected41 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA v 12.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected41 at risk
EG003
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
MedDRA v 12.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected41 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v 12.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected41 at risk
EG003
Malignant soft tissue neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)