Last updated: April 30, 2023
Sponsor: Postgraduate Institute of Medical Education and Research
Overall Status: Completed
Phase
2/3
Condition
Hepatic Fibrosis
Hyponatremia
Scar Tissue
Treatment
Growth Hormone
Standard Medical Therapy
Clinical Study ID
NCT03420144
GH in cirrhosis
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Decompensated Cirrhosis of liver irrespective of etiology
Exclusion
Exclusion Criteria:
- Acute on chronic liver failure (fulfilling either APASL or CANONIC criteria of ACLF)
- Splenic diameter of more than 18 cm
- Concomitant HCC or other active malignancy
- Upper gastrointestinal bleeding in the previous 7 days
- Portal vein thrombosis
- Severe renal dysfunction as defined by creatnine > 1.5mg/dl
- Severe cardiac dysfunction
- Uncontrolled diabetes (Hb A 1c ≥ 9) or diabetic retinopathy
- Acute infection or disseminate intravascular coagulation
- Active alcohol abuse in last 3 months
- Known hypersensitivity to GH
- HIV co-infection
- Pregnancy
- Refusal to give informed consent
Study Design
Total Participants: 76
Treatment Group(s): 2
Primary Treatment: Growth Hormone
Phase: 2/3
Study Start date:
January 15, 2018
Estimated Completion Date:
June 30, 2020
Connect with a study center
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
IndiaSite Not Available
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