Evaluation of the effects of anti-TN-alpha (Infliximab) on necrosis, inflammation, fibrosis and overall survival in patients with cryptogenic cirrhosis.
Aim: evaluation of the effects of anti-TNF-alpha (Infliximab) on necrosis, inflammation, fibrosis and overall survival in patients with cryptogenic cirrhosis.
Inclusion criteria: existence of proved cryptogenic cirrhosis; lack of experience with infliximab treatment in cirrhosis due to it.
Exclusion criteria: decompensated cirrhosis; active or latent tuberculosis.
Case group: patients with non decompensated cryptogenic cirrhosis.
Sample size: 30 patients including 15 patients in intervention group and 15 patients in control group.
intervention: treatment with anti-TNF-alpha (Infliximab) drug.
Time: first phase: three month, and second phase: three month.
Primary outcome measure: improvement of patient's MELD score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052228003N1
Registration date:2016-06-15, 1395/03/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-15, 1395/03/26
Registrant information
Name
Sanaz Taherpour
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 859 9857
Email address
taherpour.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center for infectious diseases of digestive system, research affairs of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of anti-TN-alpha (Infliximab) on necrosis, inflammation, fibrosis and overall survival in patients with cryptogenic cirrhosis.
Public title
Effect of Infliximab on treatment of cirrhosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: existence of proved cryptogenic cirrhosis; lack of experience with infliximab treatment in cirrhosis due to it; having informed consent
Exclusion criteria: Decompensated cirrhosis; active or latent tuberculosis; patient's trend to leaving the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic committee of Ahvaz Jundishpur University of Medical Sciences
Street address
Ahvaz Jundishpur University of Medical Sciences- Deputy of Research and Technology Development- Research Ethical committee
City
Ahvaz
Postal code
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.AJUMS.REC.1395.63
Health conditions studied
1
Description of health condition studied
Cryptogenic cirrhosis
ICD-10 code
K74.6
ICD-10 code description
Other and unspecified cirrhosis of liver
Primary outcomes
1
Description
improvement of MELD score
Timepoint
0- 3th month- 6th month
Method of measurement
according to creatinine, billirubine, and INR- Range: 6-40
Secondary outcomes
1
Description
decrease of numbers of hospitalization and decrease of cirrhosis complications
Timepoint
0- 3th month- 6th month
Method of measurement
Evaluation of patient's medical file and disease progression
Intervention groups
1
Description
control group: traditional conservative treatments