NCT04727320

Brief Summary

This study is a prospective study. We signed an informed consent form with patients with liver fibrosis and took tauroursodeoxycholic acid orally for half a year. After half a year, liver biopsy was performed using histopathology, immunohistochemistry, and polymerase chain reaction, Western blotting method was used to determine the expression level of fibrosis-related markers to verify the effect of taurodeoxycholic acid on patients with liver fibrosis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2021

Shorter than P25 for early_phase_1

Status
unknown

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

First Submitted

Initial submission to the registry

December 25, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 5, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

December 25, 2020

Last Update Submit

March 7, 2021

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Liver biopsy

    Synthesis of liver extracellular matrix（Synthesis, degradation）

    up to 24 weeks

Secondary Outcomes (1)

  • Liver ultrasound

    up to 24 weeks

Study Arms (2)

patient+TUDCA

EXPERIMENTAL
Drug: Tauroursodeoxycholic acid

patient+placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Tauroursodeoxycholic acidDRUG

Oral TUDCA, once a day, one tablet (250mg) at a time for 6 months

patient+TUDCA
PlaceboDRUG

Oral placebo, once a day, one tablet at a time for 6 months

patient+placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of liver cirrhosis and liver fibrosis in patients requiring medical treatment.

You may not qualify if:

  • Patients with end-stage cirrhosis, liver failure, etc. who need liver transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

ursodoxicoltaurine

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2020

First Posted

January 27, 2021

Study Start

March 5, 2021

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

March 9, 2021

Record last verified: 2021-03