Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04243655
Other study ID # AIG-G/ALFLD
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 30, 2019
Est. completion date December 31, 2020

Study information

Verified date January 2020
Source Asian Institute of Gastroenterology, India
Contact Mithun Sharma, MD, DM
Phone 08790622655
Email drmithunsharma@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ALF (ALF) is defined by three criteria: (1) rapid development of hepatocellular dysfunction (jaundice, coagulopathy), (2) hepatic encephalopathy, and (3) absence of a prior history of liver disease.

Interval between onset of acute hepatic injury (jaundice) and onset of liver failure (encephalopathy with or without coagulopathy) in such patients (icterus-encephalopathy interval; IEI) has been described to be between 4 weeks (Indian definition) to 24 weeks (AASLD-ALF study group). Further, due to the diverse natural course, ALF has been sub-classified as hyperacute (IEI ≤ 7 day), acute (IEI ≤ 4 weeks) and sub-acute ALF (IEI ≥ 5 week to ≤12 weeks) by British authors.


Description:

Since the 1960s, Liver Transplantation (LT) has emerged as a cornerstone intervention to cure liver failure. Mortality in patients with liver failure who cannot be rescued with Liver Transplantation remains high despite improvements in supportive care.

Artificial Liver Support System (ALSS) in ALF aim to remove excess inflammatory cytokines and attenuate inflammatory response, to remove albumin-bound and water-soluble toxins, to restore and preserve hepatic function and mitigate or limit the progression of multiorgan failure while hepatic recovery or liver transplant occurs. ALSS may also provide benefit in instances where LT is contraindicated.

The following beneficial effects have been documented with ALSS in ALF patients: improvement of jaundice, amelioration of hemodynamic instability, improvement of hepatic encephalopathy, SOFA score and survival.

HA 330-II is a broad-spectrum adsorbent made of neutral macroporous resin, removes toxins such as Inflammatory mediators (IL-1, IL-6, IL-8 & TNF-α) along with hepatic toxins such as phenol, mercaptan, aromatic amino acids, false neurotransmitters and indirectly ammonia by improving liver function recovery. However, this indirect ammonia removal with HA 330-II is insignificant. By removing excess inflammatory cytokines and attenuating uncontrolled immune response, HA 330-II prevents worsening of encephalopathy, improves liver function recovery and improves prognosis.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 31, 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

• Acute Liver Failure patients with SIRS and Hepatic Encephalopathy, without hyperbilirubinemia.

Exclusion Criteria:

- Patients with age less than 18 years or more than 65 years

- Extremely moribund patients with an expected life expectancy of less than 24 hours or with poor prognosis

- With poor blood clotting function and PTA <30%.

- Active Bleed

- Chronic heart, lung or kidney disease

- Malignant tumors including liver cancer

- Past history of organ transplantation

Study Design


Intervention

Device:
HA 330-II
One unit for 2-4 hours treatment, for 3 consecutive days
Drug:
Standard medical treatment (SMT)
SMT as per patients requirement- Management of cerebral edema/intracranial hypertension: prophylactic antibiotics, administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure, volume replacement and pressor support (noradrenaline, doubutamine, dopamine) as needed, NAC and correction of metabolic parameters.

Locations

Country Name City State
India Asian Institute Of Gastroenterology Hyderabad Telangana

Sponsors (1)

Lead Sponsor Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

References & Publications (3)

Larsen FS, Schmidt LE, Bernsmeier C, Rasmussen A, Isoniemi H, Patel VC, Triantafyllou E, Bernal W, Auzinger G, Shawcross D, Eefsen M, Bjerring PN, Clemmesen JO, Hockerstedt K, Frederiksen HJ, Hansen BA, Antoniades CG, Wendon J. High-volume plasma exchange in patients with acute liver failure: An open randomised controlled trial. J Hepatol. 2016 Jan;64(1):69-78. doi: 10.1016/j.jhep.2015.08.018. Epub 2015 Aug 29. — View Citation

Lee KC, Stadlbauer V, Jalan R. Extracorporeal liver support devices for listed patients. Liver Transpl. 2016 Jun;22(6):839-48. doi: 10.1002/lt.24396. Review. — View Citation

Rolando N, Wade J, Davalos M, Wendon J, Philpott-Howard J, Williams R. The systemic inflammatory response syndrome in acute liver failure. Hepatology. 2000 Oct;32(4 Pt 1):734-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of HA 330-II to prolong liver-transplantation free survival. The length of survival time after first hemofiltration treatment during the follow-up period. Up to 30 Days
Secondary Change in Systemic inflammatory response syndrome (SIRS) score. To assess efficacy of treatment. Up to 7 Days, post hemofiltration
Secondary Change in Acute Physiology and Chronic Health Evaluation (APACHE-II) score. To assess efficacy of treatment. Up to 7 Days, post hemofiltration
Secondary Change in sequential organ failure assessment (SOFA) score. To assess efficacy of treatment. Up to 7 Days, post hemofiltration
Secondary Change in chronic liver failure-sequential organ failure assessment (CLIF-SOFA) score. To assess efficacy of treatment. Up to 7 Days, post hemofiltration
See also
  Status Clinical Trial Phase
Recruiting NCT05985863 - Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure Phase 1/Phase 2
Not yet recruiting NCT04822922 - Safety of UC-MSC Transfusion for ACLF Patients Phase 2
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Completed NCT04983108 - Utility of Liver and Splenic Stiffness in Predicting Esophageal Varices in Patients With Acute on Chronic Liver Failure
Withdrawn NCT05940610 - The Safety and Efficacy of MSC-EVs in Acute/Acute-on-Chronic Liver Failure Phase 1/Phase 2
Not yet recruiting NCT05036031 - Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study
Recruiting NCT05019352 - Cytokine Adsorption in Acute-on-chronic Liver Failure N/A
Recruiting NCT05421351 - Immune Profile, Neuronal Dysfunction, Metabolomics and Ammonia in Therapeutic Response of HE in ACLF
Completed NCT02321371 - Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy. N/A
Not yet recruiting NCT06069037 - SALT for Treatment of Patients With Early ACLF N/A
Completed NCT02965560 - Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure
Recruiting NCT03713489 - Platelet Transfusion in HBV-related acute-on Chronic Liver Failure N/A
Withdrawn NCT03629015 - Safety Study of Stemchymal® in Acute Liver Failure Phase 1
Recruiting NCT04621812 - Role of Fecal Microbiota in Predicting Graft Rejection and Sepsis Among Recipients of Living Donor Liver Transplant in First Year.
Recruiting NCT04157465 - Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients N/A
Suspended NCT03737448 - TRimetazidine for acUte on Chronic Liver Failure STudy Phase 1
Recruiting NCT06128421 - Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk N/A
Recruiting NCT05700708 - Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
Completed NCT04238416 - Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF Phase 1
Completed NCT03456518 - Pattern of Acute on Chronic Liver Failure in Patient With HCV Related Chronic Liver Disease