Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia (YYFZJDTIHBVRHCIA)

November 12, 2021 updated by: Zhiyun Yang, Beijing Ditan Hospital

Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100015
        • Recruiting
        • Zhiyun Yang
        • Contact:
        • Principal Investigator:
          • Zhiyun Yang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Routine medical care
Other: Routine medical care
Routine medical care
Experimental: Yang Yin Fu Zheng Jie Du therapy
Drug: Yang Yin Fu Zheng Jie Du therapy
Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.
Other: Routine medical care
Routine medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 1 year
1 year
quality of life (QOL) questionnaire
Time Frame: 1 year
The questionnaire includes appetite, sleep, fatigue, pain, etc.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Ditan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

October 10, 2021

First Submitted That Met QC Criteria

October 10, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJDHYZY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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