Status:
UNKNOWN
G-CSF in Decompensated Cirrhosis: an Open Label Trial
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Cirrhosis, Liver
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Globally, cirrhosis is the fifth commonest cause of mortality. Its natural history is typified by an initial, largely asymptomatic, "compensated" phase followed by "decompensation" due to complication...
Eligibility Criteria
Inclusion
- Decompensated Cirrhosis of liver irrespective of etiology
Exclusion
- Acute on chronic liver failure (fulfilling either APASL or CANONIC criteria of ACLF)
- Splenic diameter of more than 18 cm
- Concomitant HCC or other active malignancy
- Upper gastrointestinal bleeding in the previous 7 days
- Portal vein thrombosis
- Severe renal dysfunction as defined by creatnine \> 1.5mg/dl
- Severe cardiac dysfunction
- Uncontrolled diabetes (Hb A 1c ≥ 9) or diabetic retinopathy
- Acute infection or disseminate intravascular coagulation
- Active alcohol abuse in last 3 months
- Known hypersensitivity to G-CSF
- HIV co-infection
- Pregnancy
- Refusal to give informed consent
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03415698
Start Date
July 1 2016
End Date
December 1 2018
Last Update
January 30 2018
Active Locations (1)
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1
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012