Trial · NCT02239562

sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS

NCT02239562, Phase 1, Completed, Christopher O'Brien, MD; results first posted 2019-11-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS. Trials, record NCT02239562. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02239562

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS
NCT number: NCT02239562
Status: Completed
Phases: Phase 1
Enrollment: 36 participants, actual
Lead sponsor: Christopher O'Brien, MD
Conditions: Autoimmune Hepatitis
Interventions: sPIF, Placebo
First posted: 2014-09-12
Last updated: 2019-11-20
Results first posted: 2019-11-20
Limitations and caveats: Due to the small number of subjects, formal statistical analysis was not performed.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	29 Day	Single Ascending Dose (SAD): Adverse events, concomitant medications: Days 1, 2, 3, 5, 8 Vital signs, Physical exams: Days 1, 2, 8 Complete blood counts (CBC), Serum chemistry, Liver function tests, Pharmacokinetics: Days 1, 2, 8 Lipids, Coagulation, Urinalysis, Pregnancy test: Days 1, 8 EKG, chest x-ray (CXR): Days 1 and 8 Multiple Ascending Dose (MAD): Adverse events, concomitant medications: Days 1, 2, 3, 4, 5, 8, 15, 29 Vital signs, Physical exams: Days 1, 2, 3, 4, 5, 8, 15, 29 CBC, Serum chemistry, Liver function tests, Pharmacokinetics: Days 1, 3, 5, 8, 15, 29 Lipids, Coagulation, Urinalysis, Pregnancy test, EKG: Days 1, 5, 29 CXR: Days 1, 29
Secondary	Number of Participants With Anti-sPIF Antibodies and Drug Interactions	29 Day	Following sPIF administration, using a validated assay, serum samples were tested for anti-sPIF antibodies

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	29 Day	All patients participating in each arm were assessed for adverse events by symptoms, physical examination and laboratory studies.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Anti-sPIF Antibodies and Drug Interactions	29 Day		participants	NUMBER

Source ClinicalTrials.gov

Results by group228

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Units
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	SAD sPIF 0.1	Liver Grade 2,3,4 Adverse Events	Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	SAD sPIF 0.5	Liver Grade 2,3,4 Adverse Events	Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	SAD sPIF 1.0	Liver Grade 2,3,4 Adverse Events	Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	MAD sPIF 0.1	Liver Grade 2,3,4 Adverse Events	Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	MAD sPIF 0.5	Liver Grade 2,3,4 Adverse Events	Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	MAD sPIF 1.0	Liver Grade 2,3,4 Adverse Events	Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	SAD sPIF 0.1	Skeletal Grade 2,3,4 Adverse Events	Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	SAD sPIF 0.5	Skeletal Grade 2,3,4 Adverse Events	Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	SAD sPIF 1.0	Skeletal Grade 2,3,4 Adverse Events	Participants
Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG	MAD sPIF 0.1	Skeletal Grade 2,3,4 Adverse Events	Participants

1 to 10 of 228Source ClinicalTrials.gov

See all 228 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SAD sPIF 0.1	6
Overall Study	STARTED	SAD sPIF 0.5	6
Overall Study	STARTED	SAD sPIF 1.0	6
Overall Study	STARTED	MAD sPIF 0.1	6
Overall Study	STARTED	MAD sPIF 0.5	6
Overall Study	STARTED	MAD sPIF 1.0	6
Overall Study	COMPLETED	SAD sPIF 0.1	6
Overall Study	COMPLETED	SAD sPIF 0.5	6
Overall Study	COMPLETED	SAD sPIF 1.0	6
Overall Study	COMPLETED	MAD sPIF 0.1	6

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	liver fullness (bloating)	Gastrointestinal disorders	Single Ascending Dose Placebo	0	6	0
other	liver fullness (bloating)	Gastrointestinal disorders	Single Ascending Dose 0.1	0	6	0
other	liver fullness (bloating)	Gastrointestinal disorders	Single Ascending Dose 0.5	0	6	0
other	liver fullness (bloating)	Gastrointestinal disorders	Single Ascending Dose 1.0	0	6	0
other	liver fullness (bloating)	Gastrointestinal disorders	Multiple Ascending Placebo	0	6	0
other	liver fullness (bloating)	Gastrointestinal disorders	Multiple Ascending Dose 0.1	0	6	0
other	liver fullness (bloating)	Gastrointestinal disorders	Multiple Ascending Dose 0.5	0	6	0
other	liver fullness (bloating)	Gastrointestinal disorders	Multiple Ascending Dose 1.0	0	6	0
other	transient skin irritation	General disorders	Single Ascending Dose Placebo	0	6	0
other	transient skin irritation	General disorders	Single Ascending Dose 0.1	1	6	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Single Ascending Dose Placebo	0	6
Total, all-cause mortality	Single Ascending Dose 0.1	0	6
Total, all-cause mortality	Single Ascending Dose 0.5	0	6
Total, all-cause mortality	Single Ascending Dose 1.0	0	6
Total, all-cause mortality	Multiple Ascending Placebo	0	6
Total, all-cause mortality	Multiple Ascending Dose 0.1	0	6
Total, all-cause mortality	Multiple Ascending Dose 0.5	0	6
Total, all-cause mortality	Multiple Ascending Dose 1.0	0	6
Total, other adverse events	Single Ascending Dose Placebo	0	6
Total, other adverse events	Single Ascending Dose 0.1	2	6

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26257082	DERIVED	PubMed
28704412	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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