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Trial record 8 of 26 for:    Recruiting, Not yet recruiting, Available Studies | "Jaundice"

Investigating the Efficacy and Safety of the Combination Treatment of Huaier Granule and Biliary Drainage for MOJ

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ClinicalTrials.gov Identifier: NCT03491254
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
zhaoyu liu, Shengjing Hospital

Brief 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.

Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 852 participants
Observational Model: Cohort
Time Perspective: Prospective
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/Cohort
Group A/exposure group
Huaier Granule & biliary drainage
Group B/non-exposure group
biliary drainage.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Median survival time (MST) [ Time Frame: 48 weeks ]
    indicate the survival time when only 50% of patients are still alive.

  3. 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.

  4. Liver function 1 [ Time Frame: 12、24、36、48 weeks ]
    Measurement of direct bilirubin

  5. Liver function 2 [ Time Frame: 12、24、36、48 weeks ]
    Measurement of total bilirubin

  6. Liver function 3 [ Time Frame: 12、24、36、48 weeks ]
    the time of reoccurrence of jaundice.

  7. 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.

  8. Adverse Events [ Time Frame: 12、24、36、48 weeks ]
    Incidence rate of Adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with malignant obstructive jaundice
Criteria

Inclusion Criteria:

  1. Male or female, aged between 18~75 years;
  2. 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;
  3. Total bilirubin >80 umol/L;
  4. Patients who are not indicated for or refused to receive surgical resection;
  5. ECOG score ≤2 or KPS score ≥60;
  6. Expected survival time ≥12 weeks;
  7. Has signed and dated the informed consent in volunteer and are willing to comply with the data collection procedures by Investigator.

Exclusion Criteria:

  1. Female patients who are pregnant or breastfeeding;
  2. Patients who are receiving concomitant intravenous chemotherapy;
  3. Patients whose malignant obstructive jaundice was caused by liver cancer;
  4. Patients who have severe coagulation disorders and massive ascites;
  5. Patients with obstructive jaundice who have concomitant fever;
  6. Patients who are not applicable for or not willing to receive biliary drainage;
  7. Patients who are not appropriate to participate in the study at discretion of the Investigator.

Information from the National Library of Medicine

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


Contacts
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Contact: zhaoyu liu, Professor +0086-18940251226 liuzhaoyu001@sina.com

Sponsors and Collaborators
zhaoyu liu

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Responsible Party: zhaoyu liu, Professor, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT03491254     History of Changes
Other Study ID Numbers: HE-201801
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Jaundice
Jaundice, Obstructive
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms