A Phase 3 interventional study of HP802-247 and Vehicle in Venous Leg Ulcers, sponsored by Healthpoint. Completed at 43 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-26.
Sponsored by Healthpoint (part of Smith & Nephew, Inc.) · Phase 3, Interventional, and Treatment
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.
This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 16-week treatment period. Vehicle looks the same as HP802-247 but contains no cells. Target wound status is evaluated at each study visit (closed, open, reopened). At wound closure or completion of treatment all subject will enter an observational safety followed up period which ends at one year after initial exposure to test article.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's enrollment of 155 is above the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Healthpoint is the lead sponsor of 34 studies on the registry; none are open to participants now.
First submitted before Healthpoint became part of Smith & Nephew, Inc..
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
Biological: HP802-247
Vehicle Control(fibrinogen solution \& thrombin solution without cells)
Biological: Vehicle
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x106 cells per mL every 14 days.
Wound Closure
Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline.
Time frame: 16 Weeks
Time in Days to Closure
Compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure, based on time in days to closure over the 16-week treatment period from baseline.
Time frame: 16 Weeks
Subjects were screened at 36 sites in the US and 3 in Canada; between November 30, 2012 and November 11, 2015; sites included independent and hospital wound clinics and private practice sites.
| Milestone | HP802-247 | Vehicle |
|---|---|---|
| Started | 77 | 78 |
| Completed | 57 | 61 |
| Not completed | 20 | 17 |
| Withdrew: Adverse event | 2 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Progressive disease | 1 | 2 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Moved from area | 2 | 1 |
| Withdrew: Trial termination | 11 | 9 |
Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline.
| participants | HP802-247 | Vehicle |
|---|---|---|
| Wound Closure | 17 | 23 |
Compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure, based on time in days to closure over the 16-week treatment period from baseline.
| Days | HP802-247 | Vehicle |
|---|---|---|
| Time in Days to Closure | 83.4 ± 33.8 | 87.1 ± 42.5 |
Collected over Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HP802-247 | 0/77 (0%) | 7/77 (9.1%) | 23/77 (29.9%) |
| Vehicle | 0/78 (0%) | 7/78 (9%) | 19/78 (24.4%) |
| Event | HP802-247 | Vehicle |
|---|---|---|
| CellulitisInfections and infestations | 2/77 | 1/78 |
| SepsisInfections and infestations | 1/77 | 0/78 |
| Skin infectionInfections and infestations | 1/77 | 0/78 |
| FallInjury, poisoning and procedural complications | 1/77 | 0/78 |
| Rib fractureInjury, poisoning and procedural complications | 1/77 | 0/78 |
| EncephalopathyNervous system disorders | 1/77 | 0/78 |
| Renal failure acuteRenal and urinary disorders | 1/77 | 0/78 |
| Urinary retentionRenal and urinary disorders | 1/77 | 0/78 |
| Peripheral ischemiaVascular disorders | 1/77 | 0/78 |
| Myocardial infarctionCardiac disorders | 0/77 | 1/78 |
| Event | HP802-247 | Vehicle |
|---|---|---|
| Skin ulcerSkin and subcutaneous tissue disorders | 11/77 | 8/78 |
| CellulitisInfections and infestations | 8/77 | 5/78 |
| Wound complicationInjury, poisoning and procedural complications | 4/77 | 4/78 |
| Wound infectonInfections and infestations | 3/77 | 1/78 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 3/77 | 0/78 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/77 | 1/78 |
| Infected skin ulcerInfections and infestations | 2/77 | 3/78 |
| Age, Categorical(Participants) | HP802-247 | Vehicle | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 37 | 44 | 81 |
| >=65 years | 32 | 26 | 58 |
| Age, Continuous(years) | HP802-247 | Vehicle | Total |
|---|---|---|---|
| Mean | 62.4 ± 15.1 | 61.0 ± 12.1 | 61.7 ± 13.6 |
| Sex: Female, Male(Participants) | HP802-247 | Vehicle | Total |
|---|---|---|---|
| Female | 28 | 32 | 60 |
| Male | 41 | 38 | 79 |
| Ethnicity (NIH/OMB)(Participants) | HP802-247 | Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 17 | 15 | 32 |
| Not Hispanic or Latino | 52 | 55 | 107 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | HP802-247 | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 11 | 24 |
| White | 51 | 58 | 109 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | HP802-247 | Vehicle | Total |
|---|---|---|---|
| Canada | 4 | 3 | 7 |
| United States | 65 | 67 | 132 |
Plan to share: Yes — Results summaries have been sent to each site for distribution to participants
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Topical Wound Spray HP802-247