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 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT04043104
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects ≥18 years of age.
2. History of radiation therapy for head and neck cancer.
3. Abnormal parotid gland function as judged by both absence of unstimulated parotid salivary flow and a stimulated parotid salivary flow in the targeted parotid gland \>0 and \<0.3 mL/min/gland after 2% citrate stimulation.
4. No evidence of recurrence of the primary malignancy by an otolaryngology (ears, nose, and throat \[ENT\]) assessment. Additionally, all subjects must be disease-free of head and neck cancer for at least 5 years following the end of treatment at screening, with the exception of subjects with a history of HPV+ OPC (base of tongue, oropharynx, pharynx, soft palate, tonsil) who must be disease free for at least 2 years following the end of treatment. Disease status will be determined by negative clinical examinations and computed tomography (CT) scans of the neck and chest. If subjects have had a magnetic resonance imaging (MRI) of the neck or a positron emission tomography (PET) scan within 6 months of screening, then a CT scan is not required, except for HPV+ OPC subjects who must have scans at 2 years post treatment.
5. Female subjects of childbearing potential (i.e., ovulating, pre-menopausal, and not surgically sterile) and all male subjects must use a medically accepted contraceptive regimen during their participation in the study and until all samples collected at 2 consecutive visits following AAV2hAQP1 administration are negative. Acceptable methods of contraception for male subjects include the following:
* Condoms with spermicide. Acceptable methods of contraception for female subjects include the following:
* Intrauterine device for at least 12 weeks prior to Screening.
* Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks prior to Screening.
* Diaphragm used in combination with spermicide.
Exclusion Criteria:
1. Pregnant or lactating women or women planning to become pregnant.
2. Any experimental therapy within 3 months before Day 1.
3. Active infection that requires the use of intravenous antibiotics and does not resolve at least 1 week before Day 1.
4. Uncontrolled ischemic heart disease (i.e., unstable angina, evidence of active ischemic heart disease on electrocardiogram \[ECG\]).
5. History of systemic autoimmune diseases affecting the salivary glands.
6. Use of systemic immunosuppressive medications (i.e., corticosteroids).
o Note: Topical, inhaled, or intranasal corticosteroids are allowed.
7. Malignancy, other than head and neck cancer, within the past 3 years, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma.
8. Active infections including, Epstein-Barr virus (EBV), cytomegalovirus (CMV), hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) infection.
9. White blood cell count \<3000/μL, absolute neutrophil count \<1500/μL, hemoglobin \<10.0 g/dL, platelet count \<100,000/μL, or absolute lymphocyte count ≤500/μL.
10. Alanine aminotransferase and/or aspartate aminotransferase \>1.5 × the upper limit of normal (ULN), alkaline phosphatase \>1.5 × ULN, or total bilirubin \>1.5 × ULN with any elevation of liver enzymes.
11. Estimated glomerular filtration rate \<60 mL/min/1.73 m2 using the Modification of Diet in Renal Disease equation.
12. Active use of tobacco products as determined by self-reporting.
13. Allergy to iodine or shellfish, and thus unable to have sialographic evaluations.
14. Allergy or hypersensitivity to glycopyrrolate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04043104
Study Brief:
Protocol Section:
NCT04043104