ClinicalTrials.gg
RecruitingNCT04597164Updated Nov 29, 2024

Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF

An observational study in Hepatitis B, Chronic and Acute-On-Chronic Liver Failure, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2020; still recruiting 5 years 10 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 29 studies in Hepatitis B, Chronic by Third Affiliated Hospital, Sun Yat-Sen University — 6 open to participants now, 7 under way, none of them phase 3. Hepatitis B, Chronic · Third Affiliated Hospital, Sun Yat-Sen University.

Started
2020
with 4 others
Observational
6 of 29
3 open now
Registered
22nd of 29
by date

Among the 29 studies in Hepatitis B, Chronic by Third Affiliated Hospital, Sun Yat-Sen University, this one is one of 5 that started in 2020, is one of 6 observational ones, and was the 22nd registered.

Hepatitis B, Chronic

895 studies on the registry are indexed under Hepatitis B, Chronic; 152 are open to participants now.

Browse Hepatitis B, Chronic studies →

Open to participants now

6 of the 29 studies in Hepatitis B, Chronic by Third Affiliated Hospital, Sun Yat-Sen University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 97 Hepatitis B, Chronic studies recruiting now, 33 (34%) set no upper age limit and 59 (61%) stop at 75 or younger; 11 take children under 18; 13 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

This study is to investigate investigate the safety and efficacy of Double plasma molecular adsorption system with sequential low-dose plasma exchange in treating 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. Non-bioartificial liver support system treatments may be effective due to previous clinical data. Plasma exchange (PE) and double plasma molecular adsorption system (DPMAS) are two common ways in clinical practice. This study is to investigate the clinical efficacy and safety of combination treatment of DPMAS and low volume PE in patients with HBV related ACLF. This study will be completed in 6 medical center. Two hundred patients with HBV related ACLF enrolled in this study are divided into trial group (DPMAS, low volume PE, and comprehensive internal medical treatment) and control group (comprehensive internal medical treatment). Symptoms, signs, laboratory tests results, adverse events, mortality rates are recorded from treatment baseline to 12 weeks.

03

Conditions studied

  • Hepatitis B, Chronic
  • Acute-On-Chronic Liver Failure

Keywords

  • hepatitis b virus
  • acute-on-chronic liver failure
  • double plasma molecular adsorption system
  • plasma exchange
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This prospective study included patients diagnosed with HBV-ACLF at the Department of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University (Guangdong Province, China).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Clinical diagnosis of chronic virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA > 0.5 year);
  2. Age from 18 to 65 years old;
  3. Clinical diagnosis of liver failure (serum total level > 10 times ; activity \< 40% and ≥20%, or prothrombin time international ratio ≤ 2.6 and > 1.5);
  4. > 50*10 E9/L.

Exclusion criteria

Exclusion Criteria:

  1. Other active liver diseases;
  2. Hepatocellular carcinoma or other ;
  3. Pregnancy or lactation;
  4. infection or congenital immune deficiency diseases;
  5. Severe diabetes, diseases; unstable infarction due to cardio-cerebrovascular events;
  6. Other important organ dysfunctions or transplantation;
  7. Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
  8. Patients can not follow-up;
  9. Investigator considering inappropriate.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Artificial liver support system group

    100 patients in this group will receive treatment of double plasma molecular adsorption system, low volume plasma exchange, and comprehensive internal medical treatment

    Other: Artificial liver support system

  • Comprehensive medical treatment group

    100 patients in this group will receive comprehensive internal medical treatment.

Interventions

  • OtherArtificial liver support system

    Patients will receive treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (PE) for three times, and comprehensive internal medical treatment. The volume of plasma adsorption in DPMAS is 5000\~6000 millilitre. The volume of fresh frozen plasma used in PE is 1000 millilitre.

06

What researchers measure

Primary outcomes

  1. Mortality or liver transplantation rate

    Mortality or liver transplantation rate at 12-week follow-up.

    Time frame: 12 weeks

Secondary outcomes

  1. Model for end-stage liver disease (MELD) score variation

    Variation of MELD score at 12 weeks after treatment. MELD score = 9.57 × loge(creatinine mg/dl) + 3.78 × loge(TBIL mg/dl) + 11.20 × loge(PT-INR) + 6.43.

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Xu W, Li Y, Wang L, Gao H, Chen J, Yuan J, Ouyang Y, Gao Y, Li J, Li X, Peng L. Efficacy and safety of combination treatment of double plasma molecular adsorption system and low volume plasma exchange for patients with hepatitis B virus related acute-on-chronic liver failure: a multicentre randomised controlled clinical trial. BMJ Open. 2021 Dec 14;11(12):e047690. doi: 10.1136/bmjopen-2020-047690. PubMed 34907041 ↗

Individual participant data

Plan to share: Yes — The study protocol, results and conclusions of this clinical trial will be published at academic conferences or in journals.

Supporting information: Study protocol, Clinical study report

Time frame: Beginning 3 months and ending 5 years following article publication.

Access criteria: Proposals should be directed to pliang@mail.sysu.edu.cn. To gain access, data requestors will need to sign a data access agreement.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2020 (actual). Primary completion is estimated for Dec 2024, 48 months after the start.

Of 71 observational studies under Hepatitis B, Chronic, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 99. This study's planned 48 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2020
First posted
Oct 22, 2020
StartActual
Dec 22, 2020
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Nov 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04597164
Responsible party
Liang Peng (Professor, Third Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Oct 22, 2020
Start date
Dec 22, 2020
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 29, 2024

Study contacts

Wenxiong Xu, Doctor
Contact
xwx1983@163.com
+8613760783281
Liang Peng, Doctor
Contact
pzp33@hotmail.com
+8613533978874
Liang Peng, Doctor
principal investigator · Third Affiliated Hospital, Sun Yat-Sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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