Drug-Induced Liver InjuryNCT03060252
Surveillance for Early Liver Injuries Caused by Zhuanggu Guanjie Pill
An observational study of Drug-Induced Liver Injury, run by Beijing 302 Hospital at 1 site in China.
Trial summary
This is a prospective registry study to surveil early liver injuries caused by Zhuanggu Guanjie Pill (ZGGJ Pill) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to ZGGJ Pill. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-Induced Liver Injury
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2017to 31 Dec 2017
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample and primary care clinic
Who may be able to join
- Individuals in accordance with indications for ZGGJ Pill, including osteoarthritis, and lumbar muscle strain;
- The age range of 18 to 70 years；
- Individuals taking ZGGJ Pill over 2 weeks;
- Abnormalities of serum biochemistry achieving one of the criteria as follows:
- 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;
- Individuals can provide informed consent form.
Who cannot join
- Individuals without indications for ZGGJ Pill;
- Inconformity with the ZGGJ Pill drug label;
- Individual taking ZGGJ Pill within 2 weeks;
- Individuals taking other hepatotoxic drugs combined with ZGGJ Pill, simultaneously;
- Inconformity with the diagnostic criteria for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Registry Study to Surveil Early Liver Injuries Caused by Zhuanggu Guanjie Pill (ZGGJ Pill)
This is a prospective registry study to surveil early liver injuries caused by Zhuanggu Guanjie Pill (ZGGJ Pill) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to ZGGJ Pill.
Read the 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 ZGGJ 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 ZGGJ Pill.
- Conditions
- Drug-Induced Liver Injury
- Keywords
- Drug-Induced Liver Injury
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The overall individuals taking ZGGJ Pill | The overall individuals taking ZGGJ Pill with recommended dosage and achieving the inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill.
The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill.
Measured: participants will be followed duration intake of ZGGJ Pill, an expected average within 8 weeks
Secondary outcomes (1)
Clinical features of early liver injuries caused by ZGGJ Pill assessed by serum parameters of liver function.
Clinical features of early liver injuries caused by ZGGJ Pill assessed by serum parameters of liver function.
Measured: Participants will be followed duration intake of ZGGJ Pill, an expected average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start25 Mar 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Induced Liver InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohe Xiao, Beijing 302 Hospital
- Investigators
- Xiao-he Xiao, Study director, 302 Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060252
- Sponsor's protocol ID
- 302-xxh-ZGGJP
- Status last verified
- Mar 2017
- First submitted
- 15 Feb 2017
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study to Surveil Early Liver Injuries Caused by Zhuanggu Guanjie Pill (ZGGJ Pill)
- ClinicalTrials.gov ID
- NCT03060252
- Acronym / sponsor ID
- 302-xxh-ZGGJP
- Conditions
- Drug-Induced Liver Injury
- Keywords
- Drug-Induced Liver Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 25 Mar 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective registry study to surveil early liver injuries caused by Zhuanggu Guanjie Pill (ZGGJ Pill) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to ZGGJ Pill.
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 ZGGJ 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 ZGGJ Pill.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The overall individuals taking ZGGJ Pill | – | –The overall individuals taking ZGGJ Pill with recommended dosage and achieving the inclusion criteria. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample and primary care clinic
Key inclusion criteria (6 listed)
- Individuals in accordance with indications for ZGGJ Pill, including osteoarthritis, and lumbar muscle strain;
- The age range of 18 to 70 years；
- Individuals taking ZGGJ Pill over 2 weeks;
- Abnormalities of serum biochemistry achieving one of the criteria as follows:
- Individuals can provide informed consent form.
Key exclusion criteria (5 listed)
- Individuals without indications for ZGGJ Pill;
- Inconformity with the ZGGJ Pill drug label;
- Individual taking ZGGJ Pill within 2 weeks;
- Individuals taking other hepatotoxic drugs combined with ZGGJ Pill, simultaneously;
- Inconformity with the diagnostic criteria for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill.
Time frame: participants will be followed duration intake of ZGGJ Pill, an expected average within 8 weeks
The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill.
1 secondary outcome
Clinical features of early liver injuries caused by ZGGJ Pill assessed by serum parameters of liver function.
Time frame: Participants will be followed duration intake of ZGGJ Pill, an expected average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao-he Xiao study director
302 Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug-Induced Liver Injury, run by Beijing 302 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-he Xiao (+86 66933322, pharmacy302xxh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill. (time frame: participants will be followed duration intake of ZGGJ Pill, an expected average within 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.