- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01341951
Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis (G-CSF)
April 25, 2011 updated by: Postgraduate Institute of Medical Education and Research
G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study
Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
In this study 4 groups have been taken.
Two groups of cases including Alcoholic patients and acute liver failure which are given G-CSF therapy and two groups of controls given standard therapy.
Primary end point is to see the mobilization of CD-34 hematopoietic cells and survival.
Secondary end point is to see the clinical and biochemical improvement in liver functions.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arun Sharma, DM
- Phone Number: 08872721666
- Email: drarunvashisht@yahoo.co.in
Study Contact Backup
- Name: Virendra Singh
- Phone Number: 09914209338
- Email: virendrasingh100@hotmail.com
Study Locations
-
-
-
Chandigarh, India, 1600012
- Recruiting
- Postgraduate Institute of Medical Education & Research Chandigarh India
-
Contact:
- Arun Sharma, DM
- Phone Number: 08872721666
- Email: drarunvashisht@yahoo.co.in
-
Sub-Investigator:
- Arun Sharma, DM Hepatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with Acute Liver failure as defined by AASLD.65
- Patients with Alcoholic hepatitis defined as follows: decades of heavy alcohol use (mean intake, approximately 100 g per day).The combination of an aspartate aminotransferase level that is elevated (but <300 IU per milliliter) and a ratio of the aspartate aminotransferase level to the alanine aminotransferase level that is more than 2, a total serum bilirubin level of more than 5 mg per deciliter (86 μmol per liter), an elevated INR, and neutrophilia.
Exclusion Criteria:
• Known hypersensitivity to filgrastim
- creatinine > 150 µmol/L
- infection or hemorrhage within the last 10 days
- documented hepatocellular carcinoma
- hepatitis B,C or human immunodeficiency virus seropositivity and pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G-CSF therapy in acute liver failure and alcoholic hepatitis
G-CSF therapy given in cases with acute liver failure and alcoholic hepatitis
|
300 I.U twice daily for 5 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
• Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical and biochemical improvement in liver functions
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: virendra singh, Postgraduate Institute of Medical Education and Research Chandigarh India
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Anticipated)
June 1, 2011
Study Completion (Anticipated)
June 1, 2011
Study Registration Dates
First Submitted
April 15, 2011
First Submitted That Met QC Criteria
April 25, 2011
First Posted (Estimate)
April 26, 2011
Study Record Updates
Last Update Posted (Estimate)
April 26, 2011
Last Update Submitted That Met QC Criteria
April 25, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Alcohol-Related Disorders
- Substance-Related Disorders
- Liver Diseases
- Hepatitis
- Liver Diseases, Alcoholic
- Alcohol-Induced Disorders
- Liver Failure
- Hepatic Insufficiency
- Liver Failure, Acute
- Hepatitis, Alcoholic
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- Lenograstim
Other Study ID Numbers
- PIMERIndia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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