Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Granulocyte Colony Stimulating Factor(G-CSF) Therapy for Patients With ACLF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01036932
Recruitment Status : Unknown
Verified December 2009 by Govind Ballabh Pant Hospital.
Recruitment status was:  Recruiting
First Posted : December 21, 2009
Last Update Posted : December 21, 2009
Information provided by:
Govind Ballabh Pant Hospital

Brief Summary:
The purpose of the study is to determine whether Granulocyte Colony Stimulating factor(G-CSF) therapy is effective in the treatment of patients with Acute on chronic liver failure(ACLF). The investigators hypothesize that ACLF is a disease where severe hepatic impairment is accompanied by impaired hepatic regeneration. BMC mobilization using G-CSF therapy, or G-CSF therapy per se would increase the regenerative capacity of the liver and shall lead to clinical, biochemical and histological improvements in patients with ACLF.

Condition or disease Intervention/treatment Phase
Acute on Chronic Liver Failure Drug: Granulocyte Colony Stimulating Factor Drug: Normal Saline Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: To Study the Safety and Efficacy of G-CSF Therapy on the CD 34 Cell Mobilization and Outcome of Patients With ACLF
Study Start Date : December 2008
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: G-CSF group
Patients with Acute on chronic liver failure after baseline investigations for the etiology of the acute event and the underlying chronic disease were given Granulocyte Colony Stimulating Factor therapy for a total duration of one month.
Drug: Granulocyte Colony Stimulating Factor
Dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.

Placebo Comparator: Placebo
After baseline characterization and work up for underlying acute and chronic liver disease, patients were given placebo along with the standard therapy
Drug: Normal Saline
dose of 1ml s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.

Primary Outcome Measures :
  1. mobilization of CD34 cells in the peripheral blood [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. clinical/ biochemical improvement in liver function profile [ Time Frame: 2 months ]
  2. frequency of multi-organ failure [ Time Frame: 2 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease.(APASL criteria)

Exclusion Criteria:

  • HCC or portal vein thrombosis. Refusal to participate in the study. Sepsis ( Any culture positive: blood, urine, focus of infection on Xray chest, any other obvious source of infection: UTI, SBP) Multi organ failure. Grade 3 or 4 hepatic encephalopathy.

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 identifier (NCT number): NCT01036932

Layout table for location information
Shiv K Sarin Recruiting
New Delhi, India, 110002
Contact: Shiv K Sarin, MD, DM    91-11-23234242 ext 5201   
Principal Investigator: Shiv K Sarin, MD, DM         
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Layout table for investigator information
Principal Investigator: Shiv K Sarin, MD, DM G B Pant Hospital, New Delhi, India
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr S.K.Sarin, Head, Gastroenterology Identifier: NCT01036932    
Other Study ID Numbers: IEC MAMC 179
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: December 21, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Failure
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Liver Failure, Acute
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic