- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00663780
Pharmacogenomic Analysis of Samples From Subjects in Study RN1004-0082
Pharmacogenomic Analysis of Blood Samples to Identify Polymorphisms That Segregate Responders From Non-Responders Following Treatment With Juvidex of Split Skin Donor Sites in Renovo's Clinical Study RN1004-0082
Study Overview
Status
Conditions
Detailed Description
Injury to the skin results in the physical disruption of the normal cellular architecture and triggers wound healing: a process involving inflammation, cell proliferation and migration, cell recruitment, angiogenesis and extracellular matrix deposition. Growth factors and cytokines released from inflammatory cells dictate the function of those cells present within the wound. There is a clinical need for treatments that accelerate healing, as current therapies in this field are largely based on empirical treatments and are often ineffective or inadequate.Juvidex contains as an active ingredient mannose-6-phosphate (M-6-P), a naturally occurring low molecular weight monosaccharide. The proposed mechanism of action for Juvidex is antagonistic and involves inhibiting the activation of TGF-β1 and TGF-β2. Juvidex is being developed by Renovo as a therapeutic agent administered to accelerate the healing of acute wounds.
Technological advances in genetics are providing scientists with the tools necessary to investigate the relationships between genetic variation and unmanipulated and drug-influenced wound healing outcomes such as the speed of healing. Determining the link between genetic variation and drug response (pharmacogenomics) is becoming an increasingly important part of drug development. For example, Iressa, which antagonises the tyrosine kinase activity of the epithelial growth factor receptor (EGFR) only works in people that have a specific variation (or polymorphism) in the DNA sequence of the EGFR gene. For Renovo, comparing the genetic make-up - (genotypes) - of subjects who respond well and those who respond poorly to a treatment, as well as those who naturally heal faster or whose wounds heal more slowly, may help to better define the most appropriate group of patients in which to target a given treatment. An additional benefit of exploring genotypes in well-defined patient populations will be to help to improve our understanding of the underlying biology of wound healing and provide new targets for drug discovery and development.
Pharmacogenomics may ultimately lead to improved treatment of wound healing by using more effective drugs and safer prescribing regimes. In order to realise these benefits we need to be able to collect samples for genotyping analysis from the associated clinical trial. Renovo wishes to examine the DNA sequence of patients enrolled into its clinical studies in order to examine the variation in patients capacity to heal wounds. This study will analyse samples from subjects participating in clinical study RN1004-0082, a double blind, placebo controlled trial to investigate the efficacy and safety of two concentrations of Juvidex in accelerating the healing of split thickness skin graft donor sites using different dosing regimes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Manchester, United Kingdom, M13 9XX
- Clinical Trials Unit, Renovo Limited
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects aged 18-85 years who have given written informed consent.
- Subjects have given written informed consent to participate in the study RN1004-0082.
Exclusion Criteria:
- Subjects who are not participating in the study RN1004-0082.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To identify polymorphisms that segregate responders from non-responders in respect of response to Juvidex in the clinical trial RN1004-0082
Time Frame: Single blood sample
|
Single blood sample
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identify polymorphisms associated with differential healing rates and associate data with additional ongoing clinical studies.
Time Frame: Single Blood Sample
|
Single Blood Sample
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RN1004-0084
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Wound
-
Brigham and Women's HospitalCompletedSurgical Wound | Wound Heal | Wound of Skin | Wound OpenUnited States
-
ConvaTec Inc.Not yet recruitingSurgical Wound, Recent | Trauma-related Wound | Dehiscence Wound | Surgical Wound LeakUnited States
-
Massachusetts General HospitalCompletedWound Healing | Traumatic Wound | Infective Wound | Iatrogenic Critical Sized Wound DefectsUnited States
-
Indus Hospital and Health NetworkCompletedWound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture.Wound Heal | Wound Complication | Wound DehiscencePakistan
-
Pulmatrix Inc.TerminatedPost Operative Wound Infection | Postoperative Wound Infection-deepUnited States
-
University of Roma La SapienzaCompletedWound Heal | Wound Surgical | Oral Soft Tissue ConditionsItaly
-
Chulalongkorn UniversityUnknownWound Heal | Wound Surgical | Donor Site ComplicationThailand
-
khalid abd aziz mohamedArmed Forces Hospitals, Southern Region, Saudi ArabiaUnknownDecreasing Wound InfectionSaudi Arabia
-
Central Finland Hospital DistrictUniversity of Eastern Finland; Tampere University HospitalActive, not recruitingWound Heal | Wound | Skin Wound | Skin Scarring | Wound of Skin | Wound Open | Wound BreakdownFinland
-
St. Borbala HospitalSemmelweis University; Department of Surgery, Jahn Ferend Dél-Pesti Kórház... and other collaboratorsTerminatedSurgical Wound | Surgical Site Infection | Wound Dehiscence, Surgical | Dehiscence of Internal Surgical WoundHungary