Hepatitis BNCT04195282
RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of HBV Related ACLF
A study testing Plasma exchange and RL-1 Novel Human-derived Bio-artificial Liver Treatment in people with Hepatitis B and Acute-On-Chronic Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with Hepatitis b virus related acute-on-chronic liver failure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Acute-On-Chronic Liver Failure
- What is being tested?
- Plasma exchange and RL-1 Novel Human-derived Bio-artificial Liver Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Dec 2019to Dec 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Age from 18 to 65 years old;
- Serum total bilirubin level > 10 times upper limit of normal;
- Prothrombin time activity < 40% and ≥30%；
- Platelets > 50*10 E9/L.
Who cannot join
- Other active liver diseases;
- Hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases;
- Other important organ dysfunctions;
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- Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
- Patients can not follow-up;
- Investigator considering inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Liang Peng, Doctor, +8613533978874, pzp33@hotmail.com
About this study
Official title: Therapeutic Effects and Safety of RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of Hepatitis b Virus Related Acute-on-chronic Liver Failure
This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with Hepatitis b virus related acute-on-chronic liver failure.
Read the detailed description
Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. But there still lacks of effective therapies in treatment of HBV related ACLF, except liver transplantation. RL-1 Novel Human-derived Bio-artificial Liver treatment may be an effective and safe therapy due to the previous clinical data. This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with HBV related ACLF.
- Conditions
- Hepatitis B, Acute-On-Chronic Liver Failure
- Being tested
- Plasma exchange, RL-1 Novel Human-derived Bio-artificial Liver Treatment
- Keywords
- hepatitis b virus, acute-on-chronic liver failure, artificial liver
- Medical subject headings
- Hepatitis B, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma exchangeOther
Patients will receive treatment of plasma exchange for three times in two weeks. The volume of fresh frozen plasma used in plasma exchange is about 2000 millilitre per time.
RL-1 Novel Human-derived Bio-artificial Liver TreatmentOther
Patients will receive RL-1 Novel Human-derived Bio-artificial Liver treatment for three times in two weeks. The volume of plasma exchanged in the system is about 4000 millilitre per time.
| Study group | Role | What they receive |
|---|---|---|
| Plasma exchange group | Active comparator | 10 patients will receive conventional treatment plus plasma exchange Receives: Other: Plasma exchange |
| RL-1 Novel Human-derived Bio-artificial Liver treatment group | Experimental | 10 patients will receive conventional treatment plus RL-1 Novel Human-derived Bio-artificial Liver treatment Receives: Other: RL-1 Novel Human-derived Bio-artificial Liver Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
All adverse events (i.e. fever, allergy, bleeding, hypotension, thrombosis) are observed in the follow-up.
Measured: 4 week
Secondary outcomes (8)
Survival rate
Whether patients will survive after treatment is observed in the follow-up.
Measured: 4 week
Symptoms
All symptoms (i.e. fatigue, appetite, nausea, vomiting, jaundice, consciousness) are observed in the follow-up.
Measured: 4 week
Blood cells
Blood cells are observed in the follow-up.
Measured: 4 week
Alanine transaminase
Alanine transaminase is observed in the follow-up.
Measured: 4 week
Total bilirubin
Total bilirubin is observed in the follow-up.
Measured: 4 week
Serum creatinine
is observed in the follow-up.
Measured: 4 week
Prothrombin time
Prothrombin time is observed in the follow-up.
Measured: 4 week
Blood ammonia
Blood ammonia is observed in the follow-up.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Liang Peng, Doctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195282
- Sponsor's protocol ID
- PL9
- Status last verified
- Dec 2019
- First submitted
- 8 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects and Safety of RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of Hepatitis b Virus Related Acute-on-chronic Liver Failure
- ClinicalTrials.gov ID
- NCT04195282
- Acronym / sponsor ID
- PL9
- Conditions
- Hepatitis B, Acute-On-Chronic Liver Failure
- Keywords
- hepatitis b virus, acute-on-chronic liver failure, artificial liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Dec 2019 (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.
This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with Hepatitis b virus related acute-on-chronic liver failure.
Detailed description
Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. But there still lacks of effective therapies in treatment of HBV related ACLF, except liver transplantation. RL-1 Novel Human-derived Bio-artificial Liver treatment may be an effective and safe therapy due to the previous clinical data. This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with HBV related ACLF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma exchange group | Active comparator | Other: Plasma exchange10 patients will receive conventional treatment plus plasma exchange |
| RL-1 Novel Human-derived Bio-artificial Liver treatment group | Experimental | Other: RL-1 Novel Human-derived Bio-artificial Liver Treatment10 patients will receive conventional treatment plus RL-1 Novel Human-derived Bio-artificial Liver treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Age from 18 to 65 years old;
- Serum total bilirubin level > 10 times upper limit of normal;
- Prothrombin time activity < 40% and ≥30%；
- Platelets > 50*10 E9/L.
Key exclusion criteria (9 listed)
- Other active liver diseases;
- Hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases;
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 |
|---|---|---|
| Plasma exchangePatients will receive treatment of plasma exchange for three times in two weeks. The volume of fresh frozen plasma used in plasma exchange is about 2000 millilitre per time. | Other | Plasma exchange group |
| RL-1 Novel Human-derived Bio-artificial Liver TreatmentPatients will receive RL-1 Novel Human-derived Bio-artificial Liver treatment for three times in two weeks. The volume of plasma exchanged in the system is about 4000 millilitre per time. | Other | RL-1 Novel Human-derived Bio-artificial Liver treatment group |
Primary outcome
Adverse events
Time frame: 4 week
All adverse events (i.e. fever, allergy, bleeding, hypotension, thrombosis) are observed in the follow-up.
8 secondary outcomes
Survival rate
Time frame: 4 week
Symptoms
Time frame: 4 week
Blood cells
Time frame: 4 week
Alanine transaminase
Time frame: 4 week
Total bilirubin
Time frame: 4 week
Serum creatinine
Time frame: 4 week
Prothrombin time
Time frame: 4 week
Blood ammonia
Time frame: 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
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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.
Liang Peng, Doctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma exchange and RL-1 Novel Human-derived Bio-artificial Liver Treatment in people with Hepatitis B and Acute-On-Chronic Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University 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 9 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 11 Dec 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Wenxiong Xu, Doctor (+8613760783281, xwx1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 4 week). 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 11 Dec 2019.