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

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: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Yang Yin Fu Zheng Jie Du therapy; Other: Routine medical care

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Zhiyun Yang, doctor; Phone Number: +8613439696988; Email: 13439696988@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100015
      • Recruiting
      • Zhiyun Yang
      • Contact: Zhiyun Yang, doctor; Phone Number: +8613439696988; Email: 13439696988@163.com
      • Principal Investigator: Zhiyun Yang, PhD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Ditan Hospital

Study record dates

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: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• 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