A Trial to Study the Influence of Growth Factors on Bone Marrow and Hepatic Regeneration in Patients With Decompensated Cirrhosis.
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|ClinicalTrials.gov Identifier: NCT01902511|
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : November 22, 2016
This will be a randomized double blind study which will be conducted on patients admitted to Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having any exclusion criteria will undergo bone marrow examination and liver biopsy at the baseline.
60 patients of decompensated cirrhosis will be randomised into two limbs- limb A (30 patients) will receive G-CSF and erythropoietin while those on limb B (30 patients) will receive G-CSF alone. The drugs will be given for 2 months and patient will be followed for 1 year. G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 60 (total 22 doses). Erythropoietin will be given s/c at dose of 500 IU/Kg twice a week for 2 months.
Follow up will be done on days 0,3,7,14,28, day 42 (6 weeks), day 60 (2 months), day 90 (3 months), day 180 (6 months), day 270 (9 months); and day 360 (1 year).
|Condition or disease||Intervention/treatment||Phase|
|Decompensated Cirrhosis||Drug: G-CSF+Erythropoetin Drug: G-CSF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
|Experimental: G-CSF + Erythropoietin||
|Active Comparator: G-CSF||
- The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis. [ Time Frame: 1 Year ]
- Histopathological evidence of hepatic regeneration and mobilization of CD34/stem cells [ Time Frame: 1 Year ]
- Histopathological evidence of contribution of bone marrow precursor cells in hepatic regeneration and the markers predicting positive response to growth factors [ Time Frame: 1 Year ]
- Development of new complications such as appearance or worsening of hepatic encephalopathy, hepatorenal syndrome and sepsis. [ Time Frame: 1 Year ]
- Improvement in severity assessment scores and safety profile of G-CSF (Growth-Colony Stimulating Factor) + EPO (Erythropoetin)dual therapy vs. G-CSF alone. [ Time Frame: 1 Year ]
- Transplant free survival at 6 months in both groups [ Time Frame: 6 months ]
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): NCT01902511
|Institute of Liver & Biliary Sciences|
|New Delhi, Delhi, India, 110070|
|Principal Investigator:||Dr Lovkesh Anand, MD||Institute of Liver & Biliary Sciences.|