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Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid

Primary Purpose

Primary Biliary Cirrhosis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Fuzhenghuayu

UDCA

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring Fuzhenghuayu

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent
Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP > 1,5N) and aminotransferase (AST or ALT > 1N) activities; c.Histological hepatic injuries consistent with PBC.
Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response.

Exclusion Criteria:

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.

Sites / Locations

Xijing Hosipital of Digestive DiseaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fuzhenghuayu+UDCA

Monotherapy

Arm Description

Regular UDCA treatment combination with Fuzhenghuayu

UDCA monotherapy

Outcomes

Primary Outcome Measures

Rate of patients with complete biochemical response

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

Secondary Outcome Measures

Change in liver biopsy examinations compared to the baseline.

Histological evolution will be checked by liver biopsy at the end of the study to compare with baseline histological status.

Change in GLOBE scores after treatment.

The prognostic scores will be calculated at entry and end of study by GLOBE scoring system.

Change in liver stiffness status measured by magnetic resonance elastography

The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography.

Change in serum alkaline phosphatase (ALP) level

Change in serum levels of ALP (IU/L) compared to the baseline.

Change in serum bilirubin level

Change in serum levels of bilirubin (mg/dL) compared to the baseline

Change in serum transaminase level

Change in serum levels of transaminase (IU/L) compared to the baseline

Full Information

NCT ID

NCT02916641

First Posted

January 28, 2016

Last Updated

September 26, 2016

Sponsor

Xijing Hospital of Digestive Diseases

1. Study Identification

Unique Protocol Identification Number

NCT02916641

Brief Title

Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xijing Hospital of Digestive Diseases

4. Oversight

5. Study Description

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 we start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Biliary Cirrhosis

Keywords

Fuzhenghuayu

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fuzhenghuayu+UDCA

Arm Type

Experimental

Arm Description

Regular UDCA treatment combination with Fuzhenghuayu

Arm Title

Monotherapy

Arm Type

Active Comparator

Arm Description

UDCA monotherapy

Intervention Type

Drug

Intervention Name(s)

Fuzhenghuayu

Intervention Type

Drug

Intervention Name(s)

UDCA

Primary Outcome Measure Information:

Title

Rate of patients with complete biochemical response

Description

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

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Change in liver biopsy examinations compared to the baseline.

Description

Histological evolution will be checked by liver biopsy at the end of the study to compare with baseline histological status.

Time Frame

Week 48

Title

Change in GLOBE scores after treatment.

Description

The prognostic scores will be calculated at entry and end of study by GLOBE scoring system.

Time Frame

Week 48

Title

Change in liver stiffness status measured by magnetic resonance elastography

Description

The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography.

Time Frame

Week 48

Title

Change in serum alkaline phosphatase (ALP) level

Description

Change in serum levels of ALP (IU/L) compared to the baseline.

Time Frame

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

Title

Change in serum bilirubin level

Description

Change in serum levels of bilirubin (mg/dL) compared to the baseline

Time Frame

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

Title

Change in serum transaminase level

Description

Change in serum levels of transaminase (IU/L) compared to the baseline

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Change in pruritus

Description

The symptom of pruritus will be evaluated by questionnaire before enrolment and at the end of the study.

Time Frame

Week 24

Title

Change in fatigue

Description

The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrolment and at the end of the study.

Time Frame

Week 24

Title

Change in serum Immunoglobulin M Levels.

Description

Absolute and percent change in serum levels of Immunoglobulin M (g/L) compared to the baseline.

Time Frame

Week 24,

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP > 1,5N) and aminotransferase (AST or ALT > 1N) activities; c.Histological hepatic injuries consistent with PBC. Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ying Han, Ph.D

Phone

86-29-84771539

hanying@fmmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yongquan Shi, Ph.D

Phone

86-29-84771515

shiyquan@fmmu.edu.cn

Facility Information:

Facility Name

Xijing Hosipital of Digestive Disease

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ying Han, Ph.D

Phone

86-29-84771539

hanying@fmmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Yongquan Shi, Ph.D

Phone

86-29-84771515

shiyquan@fmmu.edu.cn

12. IPD Sharing Statement

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Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid

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