- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02642003
To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis
Background and Aims: Liver transplantation is the only curative treatment modality for decompensated cirrhosis and is limited by donor organ availability and financial resources; thus many patients die while awaiting liver transplant. Granulocyte colony stimulating factor (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been shown to benefit patients with liver disease. The investigators evaluated the efficacy of GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial.
Patients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At the end of 6 months their survival were compared.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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New Delhi, India, 110060
- Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years to75 years
- Patients of decompensated cirrhosis with CTP ≥6 and ≤ 13
- Liver transplantation not feasible soon (due to financial reasons or unavailability of donors).
Exclusion Criteria:
- Hepatocellular Carcinoma
- Sepsis (Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP): Patients were included after sepsis is controlled.
- Any organ failure
- Grade 3 or 4 Hepatic Encephalopathy, Active Variceal bleed, Hepatorenal Syndrome: Patients might be included after clinical improvement
- HIV seropositivity
- Pregnancy
- Refusal to participate in the study
- Previous known hypersensitivity to G-CSF
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GCSF+SMT
5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months
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No Intervention: SMT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants alive at 6 months
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gastro-2014-OL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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