Hepatocellular CarcinomaEarly Phase 1NCT05088733
Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia (YYFZJDTIHBVRHCIA)
A Early Phase 1 study testing Yang Yin Fu Zheng Jie Du therapy and Routine medical care in people with Hepatocellular Carcinoma, run by Beijing Ditan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Yang Yin Fu Zheng Jie Du therapy and Routine medical care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jun 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhiyun Yang
Beijing, Beijing Municipality, 100015
Zhiyun Yang, doctor, +8613439696988, 13439696988@163.com
Zhiyun Yang, PhD
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Yang Yin Fu Zheng Jie Du therapy, Routine medical care
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yang Yin Fu Zheng Jie Du therapyDrug
Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.
Routine medical careOther
Routine medical care
| Study group | Role | What they receive |
|---|---|---|
| Yang Yin Fu Zheng Jie Du therapy | Experimental | Not described Receives: Drug: Yang Yin Fu Zheng Jie Du therapy; Other: Routine medical care |
| Routine medical care | Placebo comparator | Not described Receives: Other: Routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: 1 year
Secondary outcomes (2)
Objective response rate
Measured: 1 year
quality of life (QOL) questionnaire
The questionnaire includes appetite, sleep, fatigue, pain, etc.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Jul 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyun Yang, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088733
- Sponsor's protocol ID
- BJDHYZY
- Status last verified
- Nov 2021
- First submitted
- 10 Oct 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia
- ClinicalTrials.gov ID
- NCT05088733
- Acronym / sponsor ID
- BJDHYZY
- Conditions
- Hepatocellular Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yang Yin Fu Zheng Jie Du therapy | Experimental | Drug: Yang Yin Fu Zheng Jie Du therapy, Other: Routine medical care |
| Routine medical care | Placebo comparator | Other: Routine medical care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yang Yin Fu Zheng Jie Du therapyYang Yin Fu Zheng Jie Du is a Chinese herbal compound. | Drug | Yang Yin Fu Zheng Jie Du therapy |
| Routine medical careRoutine medical care | Other | Routine medical care, Yang Yin Fu Zheng Jie Du therapy |
Primary outcome
Survival rate
Time frame: 1 year
2 secondary outcomes
Objective response rate
Time frame: 1 year
quality of life (QOL) questionnaire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Yang Yin Fu Zheng Jie Du therapy and Routine medical care in people with Hepatocellular Carcinoma, run by Beijing Ditan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyun Yang, doctor (+8613439696988, 13439696988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.