Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia (YYFZJDTIHBVRHCIA)
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Yang Yin Fu Zheng Jie Du therapy
Routine medical care
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Meet the criteria of hepatocellular carcinoma
- Patients who tested positive for hepatitis B surface antigen (HBsAg) for >6 months
- Meet the criteria of anemia
- Ages Eligible for Study: ≤75 years old;
- Informed consent from the patient.
Exclusion Criteria:
- Patients with upper gastrointestinal bleeding within 3 months before enrollment;
- History of blood transfusion within 3 months before enrollment;
- Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
- Serious problem of heart, lung, or kidney with severe dysfunction;
- Pregnant or child breast feeding women;
- Mental or cognitive disorders;
- Participating in other drug trials;
- Who are allergic to the study drug.
Sites / Locations
- Zhiyun YangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Yang Yin Fu Zheng Jie Du therapy
Routine medical care
Arm Description
Outcomes
Primary Outcome Measures
Survival rate
Secondary Outcome Measures
Objective response rate
quality of life (QOL) questionnaire
The questionnaire includes appetite, sleep, fatigue, pain, etc.
Full Information
NCT ID
NCT05088733
First Posted
October 10, 2021
Last Updated
November 12, 2021
Sponsor
Beijing Ditan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05088733
Brief Title
Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia (YYFZJDTIHBVRHCIA)
Official Title
Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Ditan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical research of Yang Yin Fu Zheng Jie Du therapy in HBV related hepatocellular carcinoma induced anemia. The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy for patients belong to HBV-HCC induced anemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Yang Yin Fu Zheng Jie Du therapy
Arm Type
Experimental
Arm Title
Routine medical care
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Yang Yin Fu Zheng Jie Du therapy
Intervention Description
Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.
Intervention Type
Other
Intervention Name(s)
Routine medical care
Intervention Description
Routine medical care
Primary Outcome Measure Information:
Title
Survival rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
1 year
Title
quality of life (QOL) questionnaire
Description
The questionnaire includes appetite, sleep, fatigue, pain, etc.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the criteria of hepatocellular carcinoma
Patients who tested positive for hepatitis B surface antigen (HBsAg) for >6 months
Meet the criteria of anemia
Ages Eligible for Study: ≤75 years old;
Informed consent from the patient.
Exclusion Criteria:
Patients with upper gastrointestinal bleeding within 3 months before enrollment;
History of blood transfusion within 3 months before enrollment;
Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
Serious problem of heart, lung, or kidney with severe dysfunction;
Pregnant or child breast feeding women;
Mental or cognitive disorders;
Participating in other drug trials;
Who are allergic to the study drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiyun Yang, doctor
Phone
+8613439696988
Email
13439696988@163.com
Facility Information:
Facility Name
Zhiyun Yang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyun Yang, doctor
Phone
+8613439696988
Email
13439696988@163.com
First Name & Middle Initial & Last Name & Degree
Zhiyun Yang, PhD
12. IPD Sharing Statement
Learn more about this trial
Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia (YYFZJDTIHBVRHCIA)
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