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Use of HA 330-II for Hemofiltration in Patients With ALF as a Bridge to Liver Transplantation .

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ClinicalTrials.gov Identifier: NCT04243655
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Asian Institute of Gastroenterology, India

Tracking Information
First Submitted Date  ICMJE January 17, 2020
First Posted Date  ICMJE January 28, 2020
Last Update Posted Date January 28, 2020
Actual Study Start Date  ICMJE December 30, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
Efficacy of HA 330-II to prolong liver-transplantation free survival. [ Time Frame: Up to 30 Days ]
The length of survival time after first hemofiltration treatment during the follow-up period.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
  • Change in Systemic inflammatory response syndrome (SIRS) score. [ Time Frame: Up to 7 Days, post hemofiltration ]
    To assess efficacy of treatment.
  • Change in Acute Physiology and Chronic Health Evaluation (APACHE-II) score. [ Time Frame: Up to 7 Days, post hemofiltration ]
    To assess efficacy of treatment.
  • Change in sequential organ failure assessment (SOFA) score. [ Time Frame: Up to 7 Days, post hemofiltration ]
    To assess efficacy of treatment.
  • Change in chronic liver failure-sequential organ failure assessment (CLIF-SOFA) score. [ Time Frame: Up to 7 Days, post hemofiltration ]
    To assess efficacy of treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of HA 330-II for Hemofiltration in Patients With ALF as a Bridge to Liver Transplantation .
Official Title  ICMJE Use of HA 330-II for Hemofiltration in Patients With Acute Liver Failure as a Bridge to Liver Transplantation: Clinical Evaluation Protocol.
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Hemoperfusion treatment with HA 330-II, one unit for 2-4 hours treatment, for 3 consecutive days along with standard medical treatment (SMT) as per patients requirement.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute-On-Chronic Liver Failure
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Hemoperfusion treatment with HA 330-II
    Hemoperfusion treatment with HA 330-II, one unit for 2-4 hours treatment, for 3 consecutive days along with SMT as per patients requirement.
    Interventions:
    • Device: HA 330-II
    • Drug: Standard medical treatment (SMT)
  • Active Comparator: 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.
    Intervention: Drug: Standard medical treatment (SMT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mithun Sharma, MD, DM 08790622655 drmithunsharma@gmail.com
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04243655
Other Study ID Numbers  ICMJE AIG-G/ALFLD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asian Institute of Gastroenterology, India
Study Sponsor  ICMJE Asian Institute of Gastroenterology, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mithun Sharma AIG Hospitals
PRS Account Asian Institute of Gastroenterology, India
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP