Phase II AutoImmune Hepatitis
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.
Timeline
- Start
- 2019-01-01
- Primary completion
- 2019-11-01
- Completion
- 2019-12-31
Outcome
Outcome not reported
Stopped: “BioIncept changed the focus of future drug development”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Synthetic PreImplantation Factor | Peptide | 1 mg/kg | — |
| Subject | Synthetic PreImplantation Factor | Peptide | 2 mg/kg | — |
| Subject | Synthetic PreImplantation Factor | Peptide | 3 mg/kg | — |
| Subject | Synthetic PreImplantation Factor | Peptide | 4 mg/kg | — |
| Subject | Synthetic PreImplantation Factor | Peptide | 5 mg/kg | — |