Surveillance for Early Liver Injuries Caused by Xianlin Gubao Granule

Drug-Induced Liver Injury Clinical Trial

Official title:

A Registry Study to Surveil Early Liver Injuries Caused by Xianlin Gubao Granule (XLGB Granule)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03091608
• Other study ID #: 302-xxh-XLGBG
• Status: Not yet recruiting
• Phase: N/A
• First received: March 21, 2017
• Last updated: March 24, 2017
• Start date: March 25, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2017
• Source: Beijing 302 Hospital
• Contact: Xiao-he Xiao
• Phone: +86 66933322
• Email: pharmacy302xxh[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Granule (XLGB Granule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Granule.

Description:

The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to XLGB Granule.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Individuals in accordance with indications for XLGB Granule, including osteoporosis, fracture, osteoarthritis, aseptic necrosis of bone and climacteric;

2. The age range of 18 to 70 years;

3. Individuals taking XLGB Granule over 2 weeks;

4. Abnormalities of serum liver biochemistry achieving one of the criteria as follows:

(i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) =2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) = 2 ULN; (iii) alkaline phosphatase (ALP) = 2 ULN;

5. Individuals can provide informed consent form.

Exclusion Criteria:

1. Individuals without indications for XLGB Granule;

2. Unconformity to the XLGB Granule drug label;

3. Individual taking XLGB Granule less than 2 weeks;

4. Individuals taking other hepatotoxic drugs combined with XLGB Granule, simultaneously;

5. Unconformity to the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003).

Related Conditions & MeSH terms

• Drug-Induced Liver Injury
• Wounds and Injuries

Locations

Country	Name	City	State
China	302 Military Hospital	Beijing Shi	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease progression of early liver injuries caused by XLGB Granule, i.e. death, liver failure, chronic DILI, recovery.	Disease progression of early liver injuries caused by XLGB Granule, i.e. death, liver failure, chronic DILI, recovery.	8 weeks
Primary	The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule.	The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule.	participants will be followed duration intake of XLGB Granule, an expected average within 8 weeks
Secondary	Clinical features of early liver injuries caused by XLGB Granule assessed by serum parameters of liver function.	Clinical features of early liver injuries caused by XLGB Granule assessed by serum parameters of liver function.	participants will be followed duration intake of XLGB Granule, an expected average of 8 weeks