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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

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.


Condition or disease Intervention/treatment Phase
Acute-On-Chronic Liver Failure Device: HA 330-II Drug: Standard medical treatment (SMT) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Official Title: Use of HA 330-II for Hemofiltration in Patients With Acute Liver Failure as a Bridge to Liver Transplantation: Clinical Evaluation Protocol.
Actual Study Start Date : December 30, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Systemic inflammatory response syndrome (SIRS) score. [ Time Frame: Up to 7 Days, post hemofiltration ]
    To assess efficacy of treatment.

  2. Change in Acute Physiology and Chronic Health Evaluation (APACHE-II) score. [ Time Frame: Up to 7 Days, post hemofiltration ]
    To assess efficacy of treatment.

  3. Change in sequential organ failure assessment (SOFA) score. [ Time Frame: Up to 7 Days, post hemofiltration ]
    To assess efficacy of treatment.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243655


Contacts
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Contact: Mithun Sharma, MD, DM 08790622655 drmithunsharma@gmail.com

Locations
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India
Asian Institute Of Gastroenterology Recruiting
Hyderabad, Telangana, India, 500032
Contact: Mithun Sharma, MD         
Sub-Investigator: Padaki N Rao, MD DM         
Sub-Investigator: Anand Kulkarni, MD DM         
Sub-Investigator: Pramod DA, MD DM         
Sub-Investigator: Nitin Jagtap, MD DNB         
Sub-Investigator: Duvurr Nageshwar Reddy, MD DM         
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
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Principal Investigator: Mithun Sharma AIG Hospitals
Publications:
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Responsible Party: Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT04243655    
Other Study ID Numbers: AIG-G/ALFLD
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute