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Compares treatment options for Decompensated Liver Cirrhosis
Official title 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.
ClinicalTrials.gov ID: NCT07002827
What this study is testing
What is Darbepoetin?
Darbepoetin is an investigational medicine, given as an once-weekly, being studied as a potential treatment for decompensated liver cirrhosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Exogenous growth factor-mobilized bone marrow (BM) stem cells(G-CSF) and DARBEPOETIN use have shown a differential response in the management of decompensated cirrhosis (DC) with improved survival, CTP and MELD scores. This study was designed to evaluate potential clinical benefit of repeated cycles of granulocyte-colony stimulating factor (G-CSF) and DARBEPOETIN versus single cycle on delta change in immunometabolic profile of patients at 6 months assessed in terms of -Change in innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation .
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18-70 years
- Decompensated cirrhosis patients
- Uncomplicated ascites,
- CTP ≤ 9B and MELD \<16
- BM Hematopoietic stem cell reserve \> 0.4
You likely can't join if
- Patients with age less than 18 years or more than 65 years
- Lack of informed consent
- Patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any...
- Evidence of alcoholic hepatitis/active alcohol abuse last intake ≤ 3 months
- Suspected autoimmune hepatitis (ANA/ASMA-positive in titers 1:80 and/ or IgG 1.5 times upper limit of normal),
- Hemolytic anaemia -Sickle cell disease or thalassemia
See the full eligibility criteria
- Age 18-70 years
- Decompensated cirrhosis patients
- Uncomplicated ascites,
- CTP ≤ 9B and MELD \<16
- BM Hematopoietic stem cell reserve \> 0.4
- Given informed consent
- Patients with age less than 18 years or more than 65 years
- Lack of informed consent
- Patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients
- Evidence of alcoholic hepatitis/active alcohol abuse last intake ≤ 3 months
- Suspected autoimmune hepatitis (ANA/ASMA-positive in titers 1:80 and/ or IgG 1.5 times upper limit of normal),
- Hemolytic anaemia -Sickle cell disease or thalassemia
- Patients with Grade III ascites /complicated ascites
- Patients with large spleen (size ≥ 15cm)
- Recent variceal bleeding in less than 42 days
- Patients with any focus of sepsis as proven by culture positivity or presence of spontaneous Bacterial Peritonitis (SBP)
- H/o Seizures
- Hepatocellular Carcinoma (HCC) or other malignancy
- Acute Kidney Injury (AKI) with serum Creatinine \>1.5 mg/ dl,
- Multi-organ failure,
- Hepatic Encephalopathy or prior history of HE in less than 6months
- HIV seropositivity,
- Uncontrolled essential hypertension, CAD /Stroke
- Massive hydrothorax
- Pregnancy
- Viral etiology of liver disease
- Chronic kidney disease
- Portal vein thrombosis
- Planned for LT
- Bone marrow hematopoietic stem cells \< 0.4
The study team makes the final eligibility decision.
Where it's taking place
- New Delhi, National Capital Territory of Delhi, India
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Delhi, National Capital Territory of Delhi, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.