Phase II AutoImmune Hepatitis

Status Withdrawn

Clinical Trial Summary

This is a Phase IIa open label adaptive design dose finding study in male and female patients with autoimmune hepatitis (AIH) with compensated liver function currently under standard of care. The purpose of this study is to evaluate the sPIF dose that normalizes and maintains the serum ALT when given for 14 doses.

Autoimmune Hepatitis is disease where the patient's immune system produces an inappropriate immune response against their own liver. PreImplantation factor (PIF) is a substance that is secreted by viable fetuses during pregnancy. PIF 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. Specifically, sPIF protected the liver against immune attack.

Clinical Trial Description

The study is an open label, dose finding trial in patients with AIH who have an elevated ALT levels. Patients will be administered a starting dose of sPIF 1mg/kg (n=10/cohort) for 14 days assessing safety, tolerability and clinical response based on the effect on ALT levels until day 84. This will be followed by enrolling (n=10) patients administering 2mg/kg sPIF for 14 days assessing safety, tolerability and clinical response based on the effect on ALT levels until day 84. This be followed by an interim analysis that will determine clinical efficacy by comparing the 1mg and 2mg dose results; testing the decrease in mean ALT percent and determining the number of patients in remission defined as normalized ALT level. The successful cohort will enroll additional patients to enable power analysis. If no significant improvement is observed in the two cohorts, N=10 patients will be enrolled and administered 3mg/kg sPIF for 14 days assessing safety and tolerability. If no significant improvement is noted and safety and tolerability is maintained additional 10 patients will be enrolled at 4mg/kg. Following the same analysis, the maximal dose to be administered will be 5mg/kg. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03593460
Study type	Interventional
Source	University of Miami
Contact
Status	Withdrawn
Phase	Phase 2
Start date	January 1, 2019
Completion date	December 31, 2019

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.