Use of Pyrvinium to Reverse Stomach Precancerous Conditions

Korábbi kezelés

• The subject has a previous total or partial gastrectomy.
• The subject on regular anti-coagulant prophylaxis such as warfarin must be able to undergo a 5-day washout period before each gastroscopy. The subject on aspirin, ticlopidine and clopidogrel must be able to undergo a one-week washout period before each gastroscopy. The subject's physician or study co-investigator will exercise their clinical judgement to ensure subject's safety.

Más betegség

• The subject has an active gastric cancer diagnosis.
• The subject has a personal history of gastric cancer diagnosis.
• The subject has a high-risk of bleeding complications due to anticoagulants or underlying medical condition such as bleeding disorders in whom biopsies are contraindicated.
• The subject has known hypersensitivity to any components of the study product such as sucrose, benzyl alcohol, or propylene glycol .
• The subject has chronic bowel disease, (defined as Crohn's disease, ulcerative colitis and/or inflammatory bowel disease).

Laborértékek

• The subject has impaired renal function, defined as an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73m² (eGFR <60).
• The subject has impaired hepatic function, defined as any of the following laboratory abnormalities: Alanine aminotransferase (ALT) > 100 U/L, Aspartate aminotransferase (AST) > 100 U/L, Total bilirubin (Bil) > 50 µmol/L, Albumin < 30 g/L.
• The subject has any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgement of the investigator would make the subject unsuitable for entry into the study.

Egyéb

• The subject is pregnant (positive urine pregnancy test).
• The subject is unwilling or unable to provide signed informed consent.

• The subject is at least 21 years of age.
• The subject has histologically proven extensive/marked intestinal metaplasia and/or dysplasia. Extensive/ marked IM is defined by: (a) Presence of multifocal IM (IM present in antrum and body), and (b) At least one biopsy with at least moderate IM severity.
• The subject is willing and able to provide signed and dated patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.