Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009691

Trial Description

start of 1:1-Block title

Title

HepNet patient registry- secondary prevention of hepatic encephalopathy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

HE-Register

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.kompetenznetz-hepatitis.de/projekte/HepNet%20Study-House

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Hepatic encephalopathy (HE) is a neuropsychiatric disease that can occur as a result of acute and chronic liver diseases. Pathophysiologically the disease is a clinical manifestation of a low-grade, chronic Gliaödems, which leads to changes in astrocyte function with subsequent disruption of glioneurodimensional communication.
While the diagnosis of higher-grade forms of the disease will be based on clinical signs, psychometric and neurophysiological tests are needed to detect the low-grade forms of HE. The disease has a major impact on quality of life and the survival propability of patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009691
  •   2015/11/23
  •   [---]*
  •   yes
  •   Approved
  •   1994-2013, Ethikkommission der Medizinischen Hochschule Hannover
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   3796  (BfArM-NIS-Nr.)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Hepatic Encephalopathy
  •   K72.9 -  Hepatic failure, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients after hospitalization with documented clinically-manifest HE

    Documentation of standard diagnostics
    Implementation of PSE Syndrome Test
    Measurement of flicker frequencies
    Questionnaire for roadworthiness
    SF36
    Reference sample for genetic testing
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Period until the re-hospitalization because of acute episodes of clinically manifest hepatic encephalopathy

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Frequencies of the decline of the baseline Westhaven criteria
2. Change in West Haven criteria with respect to baseline
3. Changes in PSE Syndrome Test compared to baseline
4. Changes of the flicker frequency compared to baseline
5. Detection of important influencing factors on disease progression (genetic analysis, Demographics)
6. Comparison of disease progression between the forms of therapy (administration vs. non-delivery of a drug)
7. Application of relevant concomitant medications, time of first dose, duration, dose

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/01/01
  •   250
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients (> 18 years) with symptomatic hepatic encephalopathy, which required hospitalization in the last 3 months

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

hospitalization at baseline.
max. 50 patients will be enrolled with MELD> 20 (Should this have a strong negative impact on the recruitment, the number can be increased).

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Deutsche Leberstiftung
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Deutsche Leberstiftung
    • Ms.  Dr.  Svenja  Hardtke 
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Deutsche Leberstiftung
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Norgine
    • Im Schwarzenborn 4
    • D-35041   Marburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Deutsche Leberstiftung
    • Carl-Neuberg-Str1.
    • 30625  Hannover
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/03/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.