Compensated CirrhosisNCT03144700
The Natural History and Prognostic Factors of Compensated Cirrhosis.
An observational study of Compensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Compensated Cirrhosis
- How many people
- 166 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2010to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Compensated Cirrhosis
Who may be able to join
- Age 18 to 75 years
- Compensated cirrhosis
- Biopsy proven cirrhosis or LSM > 12.5 Kpa.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: The Natural History and Prognostic Factors of Compensated Cirrhosis: An Ambi Prospective Cohort Study
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.
- Conditions
- Compensated Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Compensated Cirrhosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas
Measured: 2 years
Secondary outcomes (10)
Patients with new onset/progression of esophageal varices during the period of 2 years
Measured: 2 years
Reduction in portal pressure with >20% from baseline at 6 months
Measured: 6 months
Reduction in portal pressure with >20% from baseline at 1 year
Measured: 1 year
Reduction in portal pressure with >20% from baseline at 2 year.
Measured: 2 year
Survival during the period of 2 years.
Measured: 2 years
Number of patients develop hepatocellular carcinoma (HCC) during follow up period 2 years.
Measured: 2 years
Number of patients develop Pulmonary Syndrome (HPS) during follow up period of 2 years.
Measured: 2 years
Number of patients develop Minimal Hepatic Encephalopathy (MHE) during follow up period of 2 years.
Measured: 2 years
Number of patients develop Hypersplenism during follow up period of 2 years.
Measured: 2 years
Number of patients develop Hepatic osteodystrophy during follow up period of 2 years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Jan 2010
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compensated CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144700
- Sponsor's protocol ID
- ILBS-Cirrhosis-11
- Status last verified
- Jun 2023
- First submitted
- 5 May 2017
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History and Prognostic Factors of Compensated Cirrhosis: An Ambi Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03144700
- Acronym / sponsor ID
- ILBS-Cirrhosis-11
- Conditions
- Compensated Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compensated Cirrhosis | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Compensated Cirrhosis
Key inclusion criteria (3 listed)
- Age 18 to 75 years
- Compensated cirrhosis
- Biopsy proven cirrhosis or LSM > 12.5 Kpa.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas
Time frame: 2 years
10 secondary outcomes
Patients with new onset/progression of esophageal varices during the period of 2 years
Time frame: 2 years
Reduction in portal pressure with >20% from baseline at 6 months
Time frame: 6 months
Reduction in portal pressure with >20% from baseline at 1 year
Time frame: 1 year
Reduction in portal pressure with >20% from baseline at 2 year.
Time frame: 2 year
Survival during the period of 2 years.
Time frame: 2 years
Number of patients develop hepatocellular carcinoma (HCC) during follow up period 2 years.
Time frame: 2 years
Number of patients develop Pulmonary Syndrome (HPS) during follow up period of 2 years.
Time frame: 2 years
Number of patients develop Minimal Hepatic Encephalopathy (MHE) during follow up period of 2 years.
Time frame: 2 years
Number of patients develop Hypersplenism during follow up period of 2 years.
Time frame: 2 years
Number of patients develop Hepatic osteodystrophy during follow up period of 2 years.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Compensated Cirrhosis
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Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingPhase 3
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatohepatitis
RecruitingPhase 3
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatohepatitis
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Ankit Bhardwaj, Masters CR (01146300000, bhardwaj.ankit3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.