Obstructive JaundiceNCT03491254
Investigating the Efficacy and Safety of the Combination Treatment of Huaier Granule and Biliary Drainage for MOJ
An observational study of Obstructive Jaundice, run by zhaoyu liu.
Trial summary
This study is designed to evaluate the efficacy and safety of the combination treatment of Huaier granule and biliary drainage for malignant obstructive jaundice. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Jaundice
- How many people
- 852 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2018to 31 May 2021
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Patients with malignant obstructive jaundice
Who may be able to join
- Male or female, aged between 18~75 years;
- Naïve patients who were diagnosed as malignant obstructive jaundice that was caused by carcinoma of head of pancreas, cholangiocarcinoma, gallbladder carcinoma, or duodenal papilla carcinoma, or carcinoma metastasis in hilar lymph nodes based on clinical assessments and/or pathological examination;
- Total bilirubin >80 umol/L;
- Patients who are not indicated for or refused to receive surgical resection;
- ECOG score ≤2 or KPS score ≥60;
- Expected survival time ≥12 weeks;
- Has signed and dated the informed consent in volunteer and are willing to comply with the data collection procedures by Investigator.
Who cannot join
- Female patients who are pregnant or breastfeeding;
- Patients who are receiving concomitant intravenous chemotherapy;
- Patients whose malignant obstructive jaundice was caused by liver cancer;
- Patients who have severe coagulation disorders and massive ascites;
- Patients with obstructive jaundice who have concomitant fever;
- Patients who are not applicable for or not willing to receive biliary drainage;
- Patients who are not appropriate to participate in the study at discretion of the Investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multisite, Open-label, Prospective Cohort Study Investigating Huaier Granule Combined With Biliary Drainage for Treatment of Malignant Obstructive Jaundice（MOJ）
This study is designed to evaluate the efficacy and safety of the combination treatment of Huaier granule and biliary drainage for malignant obstructive jaundice.
Read the detailed description
After sign the informed consent, the, eligible patients are those who have completed the examinations within 2 weeks after the biliary drainage will enter the study and visit the study sites at Weeks 12, 24, 36, and 48. The follow-up duration is up to 48 weeks or until the death of patient during the study. The patients will be allocated to two groups based on whether being exposed to Huaier granule or not.
Study data will be collected prospectively, including the patients' baseline characteristics, chemo-/radio-therapy history, previous Huaier granule treatment, laboratory tests, imaging examinations, and various clinical endpoints including liver function, quality of life, status of survival, and safety.
This is a non-interventional study in patient population in real world. Therefore, the patients' treatment regimen will not be interfered, i.e., the patients will independently decide whether to take Huaier granule or not based on the recommendation from the clinician after the drainage. The patients will be allocated into different groups completely according to their treatment at clinic in real world. During the study, only the study required data and endpoints will be collected.
- Conditions
- Obstructive Jaundice
- Medical subject headings
- Jaundice, Obstructive
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 |
|---|---|---|
| Group A/exposure group | Huaier Granule \& biliary drainage | |
| Group B/non-exposure group | biliary drainage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
the time interval between baseline and the time of death due to any cause
Measured: every 12 weeks until death, up to 48 weeks
Secondary outcomes (8)
overall survival rate
Overall survival rate at 48 weeks was defined as the proportion of patients who were alive at 48 weeks
Measured: 48 weeks
Median survival time (MST)
indicate the survival time when only 50% of patients are still alive.
Measured: 48 weeks
Karnofsky (KPS) score
improved is defined as KPS increases >10 after treatment; worsen is defined as KPS decreases >10; stable is defined as KPS changes ≤10.
Measured: 48 weeks
Liver function 1
Measurement of direct bilirubin
Measured: 12、24、36、48 weeks
Liver function 2
Measurement of total bilirubin
Measured: 12、24、36、48 weeks
Liver function 3
the time of reoccurrence of jaundice.
Measured: 12、24、36、48 weeks
Quality of Life (QoL) score
Quality of Life (QOL) were measured using supplemental quality of life questions. Item score range（12 items）: 1(worst symptom) to 5 (no symptom). Change: score at 48 weeks minus score at baseline.
Measured: 48 weeks
Adverse Events
Incidence rate of Adverse events
Measured: 12、24、36、48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start30 May 2018 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive JaundiceStudies 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
- 852 participants (estimated)
Sponsor and investigators
- Lead sponsor
- zhaoyu liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, zhaoyu liu, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491254
- Sponsor's protocol ID
- HE-201801
- Status last verified
- Apr 2018
- First submitted
- 22 Mar 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multisite, Open-label, Prospective Cohort Study Investigating Huaier Granule Combined With Biliary Drainage for Treatment of Malignant Obstructive Jaundice（MOJ）
- ClinicalTrials.gov ID
- NCT03491254
- Acronym / sponsor ID
- HE-201801
- Conditions
- Obstructive Jaundice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 852 participants (estimated)
- Lead sponsor
- zhaoyu liuUniversity, hospital or other
- Study start
- 30 May 2018 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 9 Apr 2018 (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 study is designed to evaluate the efficacy and safety of the combination treatment of Huaier granule and biliary drainage for malignant obstructive jaundice.
Detailed description
After sign the informed consent, the, eligible patients are those who have completed the examinations within 2 weeks after the biliary drainage will enter the study and visit the study sites at Weeks 12, 24, 36, and 48. The follow-up duration is up to 48 weeks or until the death of patient during the study. The patients will be allocated to two groups based on whether being exposed to Huaier granule or not.
Study data will be collected prospectively, including the patients' baseline characteristics, chemo-/radio-therapy history, previous Huaier granule treatment, laboratory tests, imaging examinations, and various clinical endpoints including liver function, quality of life, status of survival, and safety.
This is a non-interventional study in patient population in real world. Therefore, the patients' treatment regimen will not be interfered, i.e., the patients will independently decide whether to take Huaier granule or not based on the recommendation from the clinician after the drainage. The patients will be allocated into different groups completely according to their treatment at clinic in real world. During the study, only the study required data and endpoints will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A/exposure group | – | –Huaier Granule \& biliary drainage |
| Group B/non-exposure group | – | –biliary drainage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant obstructive jaundice
Key inclusion criteria (7 listed)
- Male or female, aged between 18~75 years;
- Naïve patients who were diagnosed as malignant obstructive jaundice that was caused by carcinoma of head of pancreas, cholangiocarcinoma, gallbladder carcinoma, or duodenal papilla carcinoma, or carcinoma metastasis in hilar lymph nodes based on clinical assessments and/or pathological examination;
- Total bilirubin >80 umol/L;
- Patients who are not indicated for or refused to receive surgical resection;
- ECOG score ≤2 or KPS score ≥60;
Key exclusion criteria (7 listed)
- Female patients who are pregnant or breastfeeding;
- Patients who are receiving concomitant intravenous chemotherapy;
- Patients whose malignant obstructive jaundice was caused by liver cancer;
- Patients who have severe coagulation disorders and massive ascites;
- Patients with obstructive jaundice who have concomitant fever;
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
Overall survival
Time frame: every 12 weeks until death, up to 48 weeks
the time interval between baseline and the time of death due to any cause
8 secondary outcomes
overall survival rate
Time frame: 48 weeks
Median survival time (MST)
Time frame: 48 weeks
Karnofsky (KPS) score
Time frame: 48 weeks
Liver function 1
Time frame: 12、24、36、48 weeks
Liver function 2
Time frame: 12、24、36、48 weeks
Liver function 3
Time frame: 12、24、36、48 weeks
Quality of Life (QoL) score
Time frame: 48 weeks
Adverse Events
Time frame: 12、24、36、48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Jaundice, run by zhaoyu liu.
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 7 inclusion and 7 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 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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 zhaoyu liu, Professor (+0086-18940251226, liuzhaoyu001@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: every 12 weeks until death, up to 48 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 24 Apr 2018.