Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP) (NCT02854761) | Clinical Trial Compass
UnknownPhase 1
Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP)
6 participantsStarted 2016-09
Plain-language summary
This study evaluates the safety and tolerability of the investigational drug EF-022 in the treatment of adult patients with Recurrent Respiratory Papillomatosis (RRP). Patients will be administered EF-022, either intramuscular or subcutaneous, for a period of 6 months. Preliminary effect of the drug on the disease will be evaluated by following the number and severity of the lesions in the respiratory tract and the effect on voice changes.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with documented diagnosis of recurrent respiratory papillomatosis
✓. Patients with measurable disease
✓. Patients presenting at least one of the following severity criteria: Derkay score ≥ 8 , Voice handicap index (VHI) ≥11
✓. Adult male and female subjects, age of 18 and above (≥18 yrs)
✓. Patients with documentation on number of debulking procedures done during past 12 months
✓. Estimated expectancy time for next debulking procedure must be at least 3 months.
✓. Must be at least 4 weeks (\>4 weeks) since last treatment including cytotoxic therapy, biological or immunotherapy, anti-viral therapy, molecularly targeted therapy or steroid treatment.
✓. Must be at least 2 weeks (\>2weeks) since last NSAID treatment.
Exclusion criteria
✕. Patient on concurrent steroids or anti-inflammatory non steroid treatment.
✕. Active autoimmune disease
✕. Known major immunodeficiency
✕. Known to be Positive for HIV, Hepatitis B surface antigen, Hepatitis C antibody
✕. Have absolute neutrophil counts below 1.5X 10\^9/L
What they're measuring
1
CTCAE v.4.03 criteria will constitute the primary safety endpoints to be monitored throughout this study