NCT03144700

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

14 years

First QC Date

May 5, 2017

Last Update Submit

June 17, 2023

Conditions

Compensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas

    2 years

Secondary Outcomes (10)

  • Patients with new onset/progression of esophageal varices during the period of 2 years

    2 years

  • Reduction in portal pressure with >20% from baseline at 6 months

    6 months

  • Reduction in portal pressure with >20% from baseline at 1 year

    1 year

  • Reduction in portal pressure with >20% from baseline at 2 year.

    2 year

  • Survival during the period of 2 years.

    2 years

  • +5 more secondary outcomes

Study Arms (1)

Compensated Cirrhosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Compensated Cirrhosis

You may qualify if:

  • Age 18 to 75 years
  • Compensated cirrhosis
  • Biopsy proven cirrhosis or LSM \> 12.5 Kpa.

You may not qualify if:

  • Any current or prior clinical decompesnation (ascites, jaundice, encephalopathy or gastrointestinal hemorrhage).
  • Pregnant Women
  • Hepatocellular Carcinoma
  • Known case of severe cardiopulmonary disease
  • Known case of severe Hepato Pulmonary Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

Central Study Contacts

Dr Ankit Bhardwaj, Masters CR

CONTACT

01146300000bhardwaj.ankit3@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 9, 2017

Study Start

January 1, 2010

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)