Growth Hormone in Decompensated Liver Cirrhosis

NCT05253287 | Completed Phase 2

• 1 other identifier: IEC-06/2021-2015
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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, encephalopathy, and jaundice, the life expectancy is markedly reduced to a median of two years. The definitive treatment in this stage, i.e., liver transplantation is limited by cost, lack of donors, and life-long immunosuppression. In addition to complications due to portal hypertension and hepatic insufficiency, decompensated cirrhosis is associated with malnutrition, sarcopenia, immune dysfunction, and impaired regeneration. Patients with cirrhosis are growth hormone (GH) resistant, with reduced insulin-like growth factor, which are linked to malnutrition and poor liver regeneration in cirrhosis. Diverse preclinical and clinical investigations in vitro and in vivo, have shown a benefit of GH in GH deficient, elderly and HIV positive patients. GH therapy in cirrhosis has been shown to improve nitrogen economy and to improve the GH resistance in a small pilot study by Donaghy et al. Also, GH therapy of short duration has shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis. GH therapy has also been shown to improve liver regeneration and protein synthesis after hepatectomy in patients of HCC with cirrhosis. However, there is a scarcity of data on clinical impact of long term administration of GH therapy in patients of cirrhosis. Hence, we undertook the present study to study the effect of growth hormone on clinical outcomes, malnutrition, immune cells and liver regeneration in patients with cirrhosis.

Conditions

Liver Cirrhosis; Fibrosis; End Stage Liver Disease; Digestive System Disease; Physiological Effect of Drugs; Growth Hormone Treatment; Sarcopenia

Keywords

Decompensated liver cirrhosis; Growth hormone

Outcome Measures

Primary Outcomes (6)

• Complication free survival

  Complications of cirrhosis - Ascites, Hepatic encephalopathy, Gastrointestinal bleeding, Bacterial infections, Acute kidney injury

  12 Month

• Transplant free survival

  Transplant free survival where event is transplant or death

  12 Month

• Incidence of complications of cirrhosis and infections

  Complications of cirrhosis - Ascites, Hepatic encephalopathy, Gastrointestinal bleeding, Bacterial infections, Acute kidney injury

  12 Month

• Change in disease severity scores (CTP score)

  The Child-Turcotte-Pugh (CTP) score is used to assess the prognosis of patients with cirrhosis. The Pugh-Child score is determined by scoring five clinical measures of liver disease (Encephalopathy, Ascites, Albumin, Bilirubin and INR). A score of 1, 2, or 3 is given to each measure, with 3 being the most severe.

  12 Month

• Change in disease severity scores (MELD Na)

  The MELD/Na score is a scoring system for accessing the severity of chronic liver disease using values as serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time and sodium, to predict survival.

  12 Month

• Treatment related adverse events

  Any adverse events related to growth hormone

  12 Month

Secondary Outcomes (8)

• Assessment of sarcopenia

  12 Month

• Change in liver frailty index

  12 Month

• Change in nitrogen balance

  12 Month

• Change in myostatin levels

  12 Month

• Change in Functional capacity of Neutrophils

  12 Month

Study Arms (2)

Standard Medical treatment

NO INTERVENTION

Standard medical therapy: diuretics, lactulose, rifaximin, diuretics, albumin infusion, nutritional support (as required)

Growth hormone + Standard medical therapy

EXPERIMENTAL

GH therapy will be initiated at a low dose of 2U/day and titrated slowly based on IGF-1 levels) subcutaneously for 1 year.

Drug: Growth Hormone

Interventions

Growth Hormone DRUG

GH therapy will be initiated at a low dose of 2U/day and titrated slowly based on IGF-1 levels) subcutaneously for 1 year.

Growth hormone + Standard medical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy \& lactation.
• Uncontrolled diabetes (Hb A1c ≥ 9) or diabetic retinopathy.
• Active sepsis.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical education and Research

Chandigarh, Uttarakhand, 160012, India

Location

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis; End Stage Liver Disease; Digestive System Diseases; Sarcopenia

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Virendra Singh, DM

  Professor and Head, Department of Hepatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Group 1 - Growth Hormone + Standard medical therapy Group 2 - Standard Medical Therapy

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: February 23, 2022
• Study Start: February 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)