Surveillance for Early Liver Injuries Caused by Xianlin Gubao Granule

• Conditions: Drug-Induced Liver Injury

• Registration Number: NCT03091608
• Lead Sponsor: Beijing 302 Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-24
• Last Update Submitted: 2017-03-24
• Study Start: 2017-03-25
• Study First Posted: 2017-03-27
• Last Update Posted: 2017-03-27
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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）.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule.

Secondary Outcome Measures

Name	Time	Method
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	Clinical features of early liver injuries caused by XLGB Granule assessed by serum parameters of liver function.

Trial Locations

Locations (1)

302 Military Hospital; 🇨🇳 Beijing Shi, Beijing, China