sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS
Status:
Completed
Trial end date:
2016-12-29
Target enrollment:
Participant gender:
Summary
The purpose of this study is to study the safety and tolerability of synthetic
PreImplantation Factor (sPIF) in female patients with autoimmune hepatitis. Autoimmune
hepatitis is a disease where the patient's immune system produces an inappropriate immune
response against their own liver. PreImplantation Factor is a substance that is secreted by
viable fetuses during pregnancy. PIF apparently initiates both maternal tolerance preventing
the loss/rejection of the fetus. Synthetic PIF (sPIF) successfully translates PIF endogenous
properties to pregnant and non-pregnant immune disorders. sPIF was found to be effective in
preclinical models of autoimmunity and transplantation (published). Specifically sPIF
protected the liver against immune attack. Toxicity studies (mice, dogs) have shown that
high-dose sPIF administration for 2 weeks followed by 2 weeks observation period demonstrated
a high safety profile. This study will evaluate the safety, tolerability and the blood level
of this synthetic version of this natural compound in the circulation.