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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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
Acute on Chronic Liver Failure Drug: Granulocyte Colony Stimulating Factor Drug: Normal Saline

Study Design

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

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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): NCT01036932


Locations
India
Shiv K Sarin Recruiting
New Delhi, India, 110002
Contact: Shiv K Sarin, MD, DM    91-11-23234242 ext 5201    shivsarin@gmail.com   
Principal Investigator: Shiv K Sarin, MD, DM         
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Investigators
Principal Investigator: Shiv K Sarin, MD, DM G B Pant Hospital, New Delhi, India
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr S.K.Sarin, Head, Gastroenterology
ClinicalTrials.gov Identifier: NCT01036932     History of Changes
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:
Liver Failure
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Liver Failure, Acute
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs