Granulocyte Colony Stimulating Factor(G-CSF) Therapy for Patients With ACLF
|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
|Condition or disease||Intervention/treatment||Phase|
|Acute on Chronic Liver Failure||Drug: Granulocyte Colony Stimulating Factor Drug: Normal Saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- mobilization of CD34 cells in the peripheral blood [ Time Frame: 1 month ]
- clinical/ biochemical improvement in liver function profile [ Time Frame: 2 months ]
- frequency of multi-organ failure [ Time Frame: 2 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036932
|Shiv K Sarin||Recruiting|
|New Delhi, India, 110002|
|Contact: Shiv K Sarin, MD, DM 91-11-23234242 ext 5201 email@example.com|
|Principal Investigator: Shiv K Sarin, MD, DM|
|Principal Investigator:||Shiv K Sarin, MD, DM||G B Pant Hospital, New Delhi, India|