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sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS | Clinical Trials | Clareo Health

COMPLETEDPHASE1

sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Synthetic PreImplantation Factor (sPIF) in Autoimmune Hepatitis

NCT02239562•Christopher O'Brien, MD

View on ClinicalTrials.gov

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.

Detailed Description

Both sPIF as well as natural PIF appears to orchestrate a complex series of cytokine effects that overall appear to cause return of proper immune function and regulation rather than a nonspecific immune suppression. PIF acts on both the innate and adaptive arms of the immune system in a dynamic, diverse and synergetic manner "per need". In the pregnancy setting, PIF maintains basal immunity required for embryo and maternal survival, and aids in tolerance for self by blocking activated T cells proliferation that would otherwise harm the embryo. The activity of PIF appears to have a dual complementary mode of action that is dependent on whether the immune system is in the basal or the stimulated immune state. The sPIF concentrations that were used are in the same range as those that are present in maternal circulation of viable pregnancy. sPIF targets three major intracellular proteins that pivotal in autoimmune control.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female, aged from 18 to 70 years old, of non-child bearing potential (to avoid the possibility if antibodies are formed to sPIF this could put the patient at risk for future fertility)
•Females must be either
•* Postmenopausal for greater than two years,
•* Postmenopausal for less than two years with an follicle stimulating hormone (FSH) level greater \> 40 million international units per milliliter (mIU/mL )
•* Or documented as surgically sterile (bilateral tubal ligation, bilateral oophorectomy or post-hysterectomy) at least three months prior to the screening evaluation
•Autoimmune hepatitis as documented by a:
•* Pretreatment score ≥15
•* Or a post-treatment score of ≥17 on the International Criteria for the Diagnosis of Autoimmune Hepatitis (Appendix 2)
•Treatment with prednisone and/or other oral, immunosuppressive drug(s) must have been stabilized for at least 6 weeks prior to screening for this study.
•Stable ALT levels with a fixed dose of their immunosuppressant medications
+12 more criteria

Exclusion Criteria

•Any other forms of chronic liver disease.
•Decompensated liver disease defined on the basis of any one of the following laboratory parameters at the screening evaluation: total bilirubin \> 1.5 × ULN, prothrombin time \> 1.2 × ULN, platelets ≤ 100,000/mm3, or albumin \< 3 g/dL OR current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage).
•Hemoglobin \< 11 g/dL at the screening evaluation.
•Serological evidence of infection with HIV upon review of the medical record.
•Evidence of hepatocellular carcinoma (i.e., screening α-fetoprotein \> 50 ng/mL or other standard of care measure).
•Subjects with, or a history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal, renal, other cardiovascular, hematologic, metabolic, endocrine, neurologic, immunologic or hematologic illness or any other major medical disorder that, in the judgment of the Investigator, would interfere with subject treatment, assessment or compliance with the protocol or should otherwise preclude their participation in this trial.
•Have received therapy with potentially hepatotoxic drugs within 3 months (90 days) prior to Day 1 or are expected to receive such therapy during the study.
•Patient who are expected to receive a change in their immunosuppressant therapies during the protocol.
•Patients who may receive chemotherapeutic agents (e.g., corticosteroids, immunoglobulins and other immune- or cytokine-based therapies) during the study for any other medical condition.

Locations (2)

Center for Liver Diseases; University of Miami

Miami, Florida, United States

Chief Scientist, BIOINCEPT, LLC / Chairman, (SIEP) / Director, Ob&Gyn CAMcare Health Center

Cherry Hill, New Jersey, United States

Key Dates

Start Date

November 14, 2014

Primary Completion Date

April 25, 2016

Completion Date

December 29, 2016

Last Updated

November 20, 2019

Enrollment

ACTUAL participants

Conditions

Autoimmune Hepatitis

Interventions

sPIF

DRUG

Placebo

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS

Inclusion Criteria

Exclusion Criteria

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