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

Capital Medical University

Status and phase: Unknown; Early Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Yang Yin Fu Zheng Jie Du therapy; Other: Routine medical care

Study type: Interventional

Funder types: Other

Identifiers

NCT05088733

BJDHYZY

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Yang Yin Fu Zheng Jie Du therapy

Experimental group

Treatment:

Other: Routine medical care

Drug: Yang Yin Fu Zheng Jie Du therapy

Routine medical care

Placebo Comparator group

Treatment:

Other: Routine medical care