Status:
COMPLETED
Growth Hormone in Decompensated Liver Cirrhosis
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Liver Cirrhosis
Fibrosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Globally, cirrhosis and liver cancer carries a huge burden and accounts for about 3.5% (2 million) of all deaths every year. Once decompensated, i.e. development of ascites, variceal bleed, encephalop...
Detailed Description
Liver disease accounts for approximately 3.5% all deaths per year around the world, cirrhosis being the 11th most common cause of death globally. Liver cirrhosis is the final stage of all progressive ...
Eligibility Criteria
Inclusion
- Age above 18 years.
- Patients having confirmed diagnosis of decompensated cirrhosis, any etiology.
- Patients having given an informed and written consent for participation in the study.
Exclusion
- Acute on chronic liver failure.
- Diagnosis of concomitant hepatocellular carcinoma or other active malignancy.
- Severe cardiac dysfunction NYHA grade III/IV, Chronic obstructive pulmonary disease GOLD C or above.
- Active alcohol abuse in last 3 months.
- Known hypersensitivity to GH.
- Human immunodeficiency virus seropositivity.
- Patients on antiviral therapy for HCV, HBV or corticosteroid for autoimmune hepatitis those who have received it within the last 6 months.
- TIPS insertion within 6 months prior to study inclusion.
- Pregnancy \& lactation.
- Uncontrolled diabetes (Hb A1c ≥ 9) or diabetic retinopathy.
- Active sepsis.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05253287
Start Date
February 1 2022
End Date
December 31 2024
Last Update
December 16 2025
Active Locations (1)
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1
Postgraduate Institute of Medical education and Research
Chandigarh, Uttarakhand, India, 160012