Surveillance for Early Liver Injuries Caused by Xianlin Gubao Pill.

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03091556

Enrollment

1000

Registered

2017-03-27

Start date

2017-03-25

Completion date

2017-12-31

Last updated

2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-Induced Liver Injury

Keywords

Drug-Induced Liver Injury

Brief summary

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

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 Pill; (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 Pill.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

1. Individuals in accordance with indications for XLGB Pill, including symptoms of osteoporosis; 2. The age range of 18 to 70 years； 3. Individuals taking XLGB Pill 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 Pill; 2. Unconformity to the XLGB Pill drug label; 3. Individual taking XLGB Pill less than 2 weeks; 4. Individuals taking other hepatotoxic drugs combined with XLGB Pill, 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）.

Design outcomes

Primary

Measure	Time frame	Description
The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Pill.	participants will be followed duration intake of XLGB Pill, an expected average within 8 weeks	The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Pill.

Secondary

Measure	Time frame	Description
Clinical features of early liver injuries caused by XLGB Pill assessed by serum parameters of liver function.	participants will be followed duration intake of XLGB Pill, an expected average of 8 weeks	Clinical features of early liver injuries caused by XLGB Pill assessed by serum parameters of liver function.

Other

Measure	Time frame	Description
Disease progression of early liver injuries caused by XLGB Pill, i.e. death, liver failure, chronic DILI, recovery.	8 weeks	Disease progression of early liver injuries caused by XLGB Pill, i.e. death, liver failure, chronic DILI, recovery.

Countries

China

Contacts

Primary ContactXiao-he Xiao

pharmacy302xxh@126.com+86 66933322

Backup ContactJia-bo Wang

pharm_sci@126.com+86 66933323

Outcome results