Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01341951
Other study ID # PIMERIndia
Secondary ID
Status Recruiting
Phase N/A
First received April 15, 2011
Last updated April 25, 2011
Start date June 2010
Est. completion date June 2011

Study information

Verified date January 2011
Source Postgraduate Institute of Medical Education and Research
Contact Arun Sharma, DM
Phone 08872721666
Email drarunvashisht@yahoo.co.in
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Granulocyte colony stimulating factor
300 I.U twice daily for 5 days

Locations

Country Name City State
India Postgraduate Institute of Medical Education & Research Chandigarh India Chandigarh

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (1)

Spahr L, Lambert JF, Rubbia-Brandt L, Chalandon Y, Frossard JL, Giostra E, Hadengue A. Granulocyte-colony stimulating factor induces proliferation of hepatic progenitors in alcoholic steatohepatitis: a randomized trial. Hepatology. 2008 Jul;48(1):221-9. doi: 10.1002/hep.22317. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary • Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization 1 year No
Secondary clinical and biochemical improvement in liver functions 1 year Yes
See also
  Status Clinical Trial Phase
Recruiting NCT00225901 - Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant Hepatic Failure Phase 1/Phase 2
Recruiting NCT01318525 - Efficacy & Safety of ALF-5755 in Patients With Nonacetaminophen Severe Acute Hepatitis & Early Stage Acute Liver Failure Phase 2
Not yet recruiting NCT05778461 - Efficacy of L-ornithine L-aspartate and Therapeutic Plasma Exchange Versus Plasma Exchange Alone in Lowering Ammonia and Improving Outcomes in Pediatric Acute Liver Failure. N/A
Completed NCT03312036 - HEpatic Regeneration With COupled Plasma Filtration and Adsorption for Liver Extracorporeal Detoxification N/A
Not yet recruiting NCT03084198 - Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure N/A
Not yet recruiting NCT05473403 - Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis N/A
Completed NCT04959110 - Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT N/A
Enrolling by invitation NCT01471262 - Right Hepatectomy in Patients Beyond 70 Years Old N/A
Recruiting NCT06263114 - Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients
Completed NCT04512014 - Perioperative Lactate Kinetics in Patient Undergoing Major Liver Surgery
Completed NCT02687763 - Safety and Efficacy of ProQuad® in Children 6-24 Month Being Evaluated for Solid Organ Transplant Early Phase 1
Completed NCT02310542 - Comparison of Two Liver Dialysis Systems : MARS Versus SPAD in Severe Liver Failure N/A
Completed NCT01394497 - Use of N-Acetylcysteine During Liver Procurement Phase 2
Completed NCT01878305 - Neuromonitoring of Hepatic Encephalopathy N/A
Not yet recruiting NCT05817994 - Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry
Withdrawn NCT01137591 - Acetaminophen in Combination With N-Acetylcysteine (NAC) Versus Placebo in Treating Fever N/A