Surveillance for Early Liver Injuries Caused by Runzao Zhiyang Capsule.

A Registry Study to Surveil Early Liver Injuries Caused by Runzao Zhiyang Capsule (RZZY Capsule).

This is a prospective registry study to surveil early liver injuries caused by Runzao Zhiyang Capsule (RZZY Capsule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to RZZY Capsule.

Study Overview

• Status: Unknown
• Conditions: Drug-Induced Liver Injury

Detailed Description

The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of RZZY Capsule; (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 RZZY Capsule.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing Shi, Beijing, China, 100039
      • 302 Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

community sample and primary care clinic

Description

Inclusion Criteria:

1. Individuals in accordance with indications for RZZY Capsule, including skin pruritus, acne vulgaris and constipation;
2. The age range of 18 to 70 years；
3. Individuals taking RZZY Capsule over 2 weeks;

4. Abnormalities of serum 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 RZZY Capsule;
2. Unconformity with the RZZY Capsule drug label;
3. Individual taking RZZY Capsule less than 2 weeks;
4. Individuals taking other hepatotoxic drugs combined with RZZY Capsule, simultaneously;
5. Unconformity with the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
The individuals taking RZZY Capsule; The overall individuals taking RZZY Capsule with recommended dosage and achieving the inclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of RZZY Capsule.	The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of RZZY Capsule.	participants will be followed duration intake of RZZY Capsule, an expected average within 8 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression of early liver injuries caused by RZZY Capsule, i.e. death, liver failure, chronic DILI, recovery.	Disease progression of early liver injuries caused by RZZY Capsule, i.e. death, liver failure, chronic DILI, recovery.	8 weeks

Collaborators and Investigators

• Sponsor: Beijing 302 Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 25, 2017
• Primary Completion (ANTICIPATED): December 31, 2017
• Study Completion (ANTICIPATED): December 31, 2017

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (ACTUAL): March 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Drug-Induced Liver Injury
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Liver Diseases; Drug-Related Side Effects and Adverse Reactions; Poisoning; Wounds and Injuries; Chemical and Drug Induced Liver Injury
• Other Study ID Numbers: 302-xxh-RZZYC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No