Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis.
NCT ID: NCT07002827
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-30
2026-04-30
Brief Summary
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Detailed Description
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Study population:
* Age 18-70 years
* Early decompensated cirrhosis MELD \< 16 , CTP \< 9B
* Uncomplicated ascites
* A Prospective Randomized Controlled Trial.
* Single Centre.
* Open label.
* Block Randomization will be done , it will be implemented by IWRS method.
* The study will be conducted in Department of Hepatology, ILBS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Medical treatment
Standard medical therapy including lactulose, bowel enema and albumin will be continued in both groups.
Lactulose
Standard Medical Tretament part
Albumin
Standard Medical Tretament part
Single cycle of G-CSF + darbepoetin and standard medical treatment
* G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30.
* Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month.
* Standard medical therapy including lactulose, bowel enema and albumin will be continued in both groups.
Darbepoetin
Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month
G-CSF
G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30
Lactulose
Standard Medical Tretament part
Albumin
Standard Medical Tretament part
Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)
* G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30.
* Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month.
* Standard medical therapy including lactulose, bowel enema and albumin will be continued in both groups.
Darbepoetin
Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month
G-CSF
G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30
Lactulose
Standard Medical Tretament part
Albumin
Standard Medical Tretament part
Interventions
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Darbepoetin
Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month
G-CSF
G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30
Lactulose
Standard Medical Tretament part
Albumin
Standard Medical Tretament part
Eligibility Criteria
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Inclusion Criteria
2. Decompensated cirrhosis patients
3. Uncomplicated ascites,
4. CTP ≤ 9B and MELD \<16
5. BM Hematopoietic stem cell reserve \> 0.4
6. Given informed consent
Exclusion Criteria
2. Lack of informed consent
3. Patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients
4. Evidence of alcoholic hepatitis/active alcohol abuse last intake ≤ 3 months
5. Suspected autoimmune hepatitis (ANA/ASMA-positive in titers 1:80 and/ or IgG 1.5 times upper limit of normal),
6. Hemolytic anaemia -Sickle cell disease or thalassemia
7. Patients with Grade III ascites /complicated ascites
8. Patients with large spleen (size ≥ 15cm)
9. Recent variceal bleeding in less than 42 days
10. Patients with any focus of sepsis as proven by culture positivity or presence of spontaneous Bacterial Peritonitis (SBP)
11. H/o Seizures
12. Hepatocellular Carcinoma (HCC) or other malignancy
13. Acute Kidney Injury (AKI) with serum Creatinine \>1.5 mg/ dl,
14. Multi-organ failure,
15. Hepatic Encephalopathy or prior history of HE in less than 6months
16. HIV seropositivity,
17. Uncontrolled essential hypertension, CAD /Stroke
18. Massive hydrothorax
19. Pregnancy
20. Viral etiology of liver disease
21. Chronic kidney disease
22. Portal vein thrombosis
23. Planned for LT
24. Bone marrow hematopoietic stem cells \< 0.4
18 Years
70 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Principal Investigators
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Dr Manoj Kumar Sharma, DM
Role: STUDY_DIRECTOR
Institute of Liver and Biliary Sciences
Locations
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Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ILBS-Cirrhosis-73
Identifier Type: -
Identifier Source: org_study_id
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