NCT02916290

Brief Summary

Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA (13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation. However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver fibrosis might jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for liver fibrosis and cirrhosis. Both lab research and some clinical studies suggest that Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. Here the investigators start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

January 28, 2016

Last Update Submit

September 26, 2016

Conditions

Primary Biliary Cirrhosis

Keywords

Fuzhenghuayu

Outcome Measures

Primary Outcomes (1)

  • Rate of patients with complete biochemical response

    Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.

    Week 48

Secondary Outcomes (6)

  • Change in liver biopsy examinations compared to the baseline.

    Week 48

  • GLOBE scores.

    Week 48

  • Change in liver stiffness status measured by magnetic resonance elastography.

    Week 48

  • Change in serum alkaline phosphatase (ALP) level

    Weeks 0, 4, 8, 12, 24, and 48

  • Change in serum bilirubin level

    Weeks 0, 4, 8, 12, 24, and 48

  • +1 more secondary outcomes

Other Outcomes (3)

  • Change in pruritus from baseline

    Week 48

  • Change in fatigue from baseline

    Week 48

  • Change in serum Immunoglobulin M Levels

    Week 48

Study Arms (2)

Fuzhenghuayu+UDCA

EXPERIMENTAL

Regular UDCA treatment combination with Fuzhenghuayu

Drug: FuzhenghuayuDrug: UDCA

Monotherapy

ACTIVE COMPARATOR

UDCA monotherapy

Drug: UDCA

Interventions

FuzhenghuayuDRUG
Fuzhenghuayu+UDCA
UDCADRUG
Fuzhenghuayu+UDCAMonotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Patient with PBC defined by 2 in 3 of the following criteria:
  • Positive antimitochondrial antibody type M2;
  • Abnormal serum alkaline phosphatases (ALP \> 1,5N) and aminotransferase (AST or ALT \> 1N) activities;
  • Histological hepatic injuries consistent with PBC.

You may not qualify if:

  • Pregnancy or desire of pregnancy.
  • Breast-feeding.
  • Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis.
  • History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
  • History of urolithiasis, nephritis or renal failure (clearance of creatinine \< 60 ml/mn).
  • Hepatotoxic drugs use before recruiting.
  • Fuzhenghuayu anaphylaxis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ying Han, Ph.D

CONTACT

86-29-84771539hanying@fmmu.edu.cn

Yongquan Shi, Ph.D

CONTACT

86-29-84771515shiyquan@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Consultant Physician

Study Record Dates

First Submitted

January 28, 2016

First Posted

September 27, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

CN(1)