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Trial record 29 of 391 for:    Recruiting, Not yet recruiting, Available Studies | Cirrhosis

The Natural History and Prognostic Factors of Compensated Cirrhosis.

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ClinicalTrials.gov Identifier: NCT03144700
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:

Study Design and Methodology

  • Study Population:Compensated Cirrhosis
  • Study Design: An Ambi Prospective Cohort study
  • Study Period: 2 Years
  • Sample size: Retrospective- All patients from Jan 2010 to Mar 2017 Prospective- Assuming the incidence of clinical decompensation is 5%/year.With alpha of 5%, power 80% we need to enroll 138 cases. Further assuming 20% drop out 166 cases will be enrolled.
  • Intervention: This is an observational study. No intervention will be given.

Monitoring and assessment: All the routine investigation and clinical information will be collected at 6, 12,18 and 24 months.


Condition or disease
Compensated Cirrhosis

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Study Type : Observational
Estimated Enrollment : 166 participants
Observational Model: Other
Time Perspective: Other
Official Title: The Natural History and Prognostic Factors of Compensated Cirrhosis: An Ambi Prospective Cohort Study
Actual Study Start Date : January 1, 2010
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Group/Cohort
Compensated Cirrhosis



Primary Outcome Measures :
  1. Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Patients with new onset/progression of esophageal varices during the period of 2 years [ Time Frame: 2 years ]
  2. Reduction in portal pressure with >20% from baseline at 6 months [ Time Frame: 6 months ]
  3. Reduction in portal pressure with >20% from baseline at 1 year [ Time Frame: 1 year ]
  4. Reduction in portal pressure with >20% from baseline at 2 year. [ Time Frame: 2 year ]
  5. Survival during the period of 2 years. [ Time Frame: 2 years ]
  6. Number of patients develop hepatocellular carcinoma (HCC) during follow up period 2 years. [ Time Frame: 2 years ]
  7. Number of patients develop Pulmonary Syndrome (HPS) during follow up period of 2 years. [ Time Frame: 2 years ]
  8. Number of patients develop Minimal Hepatic Encephalopathy (MHE) during follow up period of 2 years. [ Time Frame: 2 years ]
  9. Number of patients develop Hypersplenism during follow up period of 2 years. [ Time Frame: 2 years ]
  10. Number of patients develop Hepatic osteodystrophy during follow up period of 2 years. [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Compensated Cirrhosis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144700


Contacts
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Contact: Dr Ankit Bhardwaj, Masters CR 01146300000 bhardwaj.ankit3@gmail.com

Locations
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India
Institute of Liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03144700     History of Changes
Other Study ID Numbers: ILBS-Cirrhosis-11
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases