Understanding the progression and factors affecting compensated cirrhosis
The Natural History and Prognostic Factors of Compensated Cirrhosis: An Ambi Prospective Cohort Study
This study looks at how compensated cirrhosis changes over two years and what factors might affect it in adults aged 18 to 75 who have been diagnosed with the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 166 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, Delhi) |
| Trial ID | NCT03144700 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the natural history and prognostic factors associated with compensated cirrhosis over a two-year period. It will involve a cohort of patients aged 18 to 75 years who have biopsy-proven cirrhosis or significant liver stiffness measurements. Data will be collected through routine investigations and clinical assessments at multiple time points throughout the study. The study will enroll approximately 166 cases to ensure sufficient power for analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 years with compensated cirrhosis confirmed by biopsy or liver stiffness measurement.
Not a fit: Patients with a history of clinical decompensation, hepatocellular carcinoma, or severe cardiopulmonary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the progression of compensated cirrhosis, potentially leading to improved management strategies for patients.
How similar studies have performed: While there have been studies on cirrhosis, this specific observational approach focusing on compensated cirrhosis and its prognostic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 to 75 years 2. Compensated cirrhosis 3. Biopsy proven cirrhosis or LSM \> 12.5 Kpa. Exclusion Criteria: 1. Any current or prior clinical decompesnation (ascites, jaundice, encephalopathy or gastrointestinal hemorrhage). 2. Pregnant Women 3. Hepatocellular Carcinoma 4. Known case of severe cardiopulmonary disease 5. Known case of severe Hepato Pulmonary Syndrome
Where this trial is running
New Delhi, Delhi
- Institute of Liver and Biliary Sciences — New Delhi, Delhi, India (Recruiting)
Study contacts
- Study coordinator: Dr Ankit Bhardwaj, Masters CR
- Email: bhardwaj.ankit3@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.