Investigating the Efficacy and Safety of the Combination Treatment of Huaier Granule and Biliary Drainage for MOJ
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03491254|
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : April 24, 2018
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||852 participants|
|Official Title:||A Multisite, Open-label, Prospective Cohort Study Investigating Huaier Granule Combined With Biliary Drainage for Treatment of Malignant Obstructive Jaundice（MOJ）|
|Estimated Study Start Date :||May 30, 2018|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||May 31, 2021|
Group A/exposure group
Huaier Granule & biliary drainage
Group B/non-exposure group
- 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
- overall survival rate [ Time Frame: 48 weeks ]Overall survival rate at 48 weeks was defined as the proportion of patients who were alive at 48 weeks
- Median survival time (MST) [ Time Frame: 48 weeks ]indicate the survival time when only 50% of patients are still alive.
- Karnofsky (KPS) score [ Time Frame: 48 weeks ]improved is defined as KPS increases >10 after treatment; worsen is defined as KPS decreases >10; stable is defined as KPS changes ≤10.
- Liver function 1 [ Time Frame: 12、24、36、48 weeks ]Measurement of direct bilirubin
- Liver function 2 [ Time Frame: 12、24、36、48 weeks ]Measurement of total bilirubin
- Liver function 3 [ Time Frame: 12、24、36、48 weeks ]the time of reoccurrence of jaundice.
- Quality of Life (QoL) score [ Time Frame: 48 weeks ]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.
- Adverse Events [ Time Frame: 12、24、36、48 weeks ]Incidence rate of Adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491254
|Contact: zhaoyu liu, Professoremail@example.com|