Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT02854761
Eligibility Criteria:
Inclusion Criteria:
1. Patients with documented diagnosis of recurrent respiratory papillomatosis
2. Patients with measurable disease
3. Patients presenting at least one of the following severity criteria: Derkay score ≥ 8 , Voice handicap index (VHI) ≥11
4. Adult male and female subjects, age of 18 and above (≥18 yrs)
5. Patients with documentation on number of debulking procedures done during past 12 months
6. Estimated expectancy time for next debulking procedure must be at least 3 months.
7. 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.
8. Must be at least 2 weeks (\>2weeks) since last NSAID treatment.
9. Must have adequately recovered (to at least Grade 1 level) from adverse effects of prior therapies.
10. Female of child bearing potential must have a negative pregnancy test and must be practicing an effective method of birth control
11. Patients or their guardians must sign an informed consent indicating that they are aware of the investigational nature of this study
Exclusion Criteria:
1. Patient on concurrent steroids or anti-inflammatory non steroid treatment.
2. Active autoimmune disease
3. Known major immunodeficiency
4. Known to be Positive for HIV, Hepatitis B surface antigen, Hepatitis C antibody
5. Have absolute neutrophil counts below 1.5X 10\^9/L
6. Hemoglobin below 10.0 g/dL
7. White blood cell counts below 3.5X10\^9/L.
8. Granulocytes below 1.5X10\^9/L.
9. Have Platelets below 100 X 10\^9/L
10. Abnormal renal function with creatinine above 1.5X the upper limit of normal (ULN)
11. Abnormal liver function tests with bilirubin above 1.5X the ULN, AST and ALT above 2.5 X ULN.
12. Patients with active cardiovascular disease under continuous treatment
13. Patients with associated malignancy currently receiving chemotherapy and/or radiation.
14. Female adult patients that are pregnant, nursing or plan to nurse during and up to 12 months of treatment period.
15. Subjects receiving another investigational drug.
16. Patients with concurrent or history of malignancy within 5 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02854761
Study Brief:
Protocol Section:
NCT02854761