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

Early Phase 1

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Yang Yin Fu Zheng Jie Du therapy; Other: Routine medical care

• Registration Number: NCT05088733
• Lead Sponsor: Beijing Ditan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-10-10
• Study First Submitted QC: 2021-10-10
• Study First Posted: 2021-10-22
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-19
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yang Yin Fu Zheng Jie Du therapy	Yang Yin Fu Zheng Jie Du therapy	-
Yang Yin Fu Zheng Jie Du therapy	Routine medical care	-
Routine medical care	Routine medical care	-

Primary Outcome Measures

Name	Time	Method
Survival rate	1 year

Secondary Outcome Measures

Name	Time	Method
quality of life (QOL) questionnaire	1 year	The questionnaire includes appetite, sleep, fatigue, pain, etc.
Objective response rate	1 year

Trial Locations

Locations (1)

Zhiyun Yang; 🇨🇳 Beijing, Beijing, China