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I-020502

Phase 2

Burns | Small molecule | Other |Baxter International Inc.|Last Updated: Mar 3, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00471939Safety and Efficacy of I-020502 in Meshed Skin AutograftingPHASE2 COMPLETED 10 — — Apr 1, 2007Jan 1, 2009Mar 3, 20091 Germany
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Study Endpoints
Primary Endpoints
Incidence of treatment-related adverse events up to 28 days post surgery
28 days
Secondary Endpoints
Incidence of AE/SAE, Changes in vital signs, Hematology/clinical chemistry, PDGF.AB/TG-PDGF.AB and antibodies, hypergranulation, Percentage and proportion of re-epithelialization/engraftment, Scar assessment, Time and resources for test site treatments
28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
I-020502DRUG1 mcg/mL TG-PDGF.AB
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Written informed consent by the patient or his/her legal representative. 2. Male or female, aged ≥ 18 years. 3. Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening). 4. Patients with burn wound(s) between ≥ 5 % and ≤ 50 %...

Countries:Germany
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