NCT02878863

Brief Summary

An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

August 9, 2016

Last Update Submit

July 10, 2017

Conditions

Hepatitis, Autoimmune

Outcome Measures

Primary Outcomes (1)

  • Percent of patients that achieve biochemical remission of AIH

    Biochemical remission is defined as alanine transaminase(ALT),aspartate transaminase(AST) and immunoglobulin G(IgG) within normal limits

    Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only

Secondary Outcomes (6)

  • Alanine transaminase (ALT)

    Month 1, 3, 6

  • Aspartate transaminase(AST)

    Month 1, 3, 6

  • Immunoglobulin G(IgG)

    Month 1, 3, 6

  • Globin(GLB)

    Month 1, 3, 6

  • Total bilirubin(TB)

    Month 1, 3, 6

  • +1 more secondary outcomes

Study Arms (2)

Paeoniflorin + phosphatidylcholine or silymarin

EXPERIMENTAL

Paeoniflorin tablets(600mg, tid)combination of phosphatidylcholine or silymarin

Drug: Paeoniflorin + phosphatidylcholine or silymarin

Phosphatidylcholine or silymarin

ACTIVE COMPARATOR

Phosphatidylcholine or silymarin

Drug: Phosphatidylcholine or silymarin

Interventions

Paeoniflorin + phosphatidylcholine or silymarinDRUG
Also known as: total glucosides of paeony(TGP)+ phosphatidylcholine or silymarin
Paeoniflorin + phosphatidylcholine or silymarin
Phosphatidylcholine or silymarinDRUG
Phosphatidylcholine or silymarin

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 20-70 years;
  • Diagnosed with AIH or primary biliary cirrhosis-autoimmune hepatitis overlap syndrome based on liver biopsy results and without indication of immunosuppressive therapy;
  • High levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)(1-3 X ULN);
  • High levels of IgG(1-1.5 X ULN);
  • Liver biopsy showed mild lymphocytic piecemeal necrosis (interface hepatitis);
  • Agreed to participate in the trial, and assigned informed consent.

You may not qualify if:

  • The presence of hepatitis A, B, C, D, or E virus infection;
  • Patients with presence of liver cirrhosis or portal hypertension;
  • Patients with presence of fulminant liver failure;
  • Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
  • Pregnant and breeding women;
  • Severe disorders of other vital organs, such as severe heart failure, cancer;
  • Parenteral administration of blood or blood products within 6 months before screening;
  • Recent treatment with drugs having known liver toxicity;
  • Taken part in other clinic trials within 6 months before screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

peoniflorinPhosphatidylcholinesSilymarin

Condition Hierarchy (Ancestors)

Hepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

GlycerophospholipidsPhosphatidic AcidsGlycerophosphatesPhospholipidsMembrane LipidsLipidsFlavonolignansFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Li Yang, MD

    West China Hospital,Chengdu, Sichuan, China

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 25, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

CN(1)