NCT05088733

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for early_phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Jul 2020

Typical duration for early_phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

October 10, 2021

Last Update Submit

November 12, 2021

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    1 year

Secondary Outcomes (2)

  • Objective response rate

    1 year

  • quality of life (QOL) questionnaire

    1 year

Study Arms (2)

Yang Yin Fu Zheng Jie Du therapy

EXPERIMENTAL
Drug: Yang Yin Fu Zheng Jie Du therapyOther: Routine medical care

Routine medical care

PLACEBO COMPARATOR
Other: Routine medical care

Interventions

Yang Yin Fu Zheng Jie Du therapyDRUG

Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.

Yang Yin Fu Zheng Jie Du therapy
Routine medical careOTHER

Routine medical care

Routine medical careYang Yin Fu Zheng Jie Du therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhiyun Yang

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Zhiyun Yang, doctor

CONTACT

+861343969698813439696988@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Archiater, Professor

Study Record Dates

First Submitted

October 10, 2021

First Posted

October 22, 2021

Study Start

July 1, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations

CN(1)