To Study and Compare the Clinical Course and Development of Organ Failure in Severe Acute Hepatitis Without Ascites, Non-cirrhotic and Cirrhotic Patients With Ascites [Acute on Chronic Liver Failure] and Acute Deterioration of Previously Decompensated Cirrhosis.

An observational study of Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The study will be conducted on patients admitted to Department of Hepatology from MARCH 2015 to DECEMBER 2016 at ILBS, New Delhi.All patients presenting to ILBS fulfilling the inclusion criteria will be included in the study and will be categorized and evaluated. The patient will followed over a period of 3 months. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cirrhosis
How many people: 0 participants
Where: 1 siteIndia
Study dates: Start not givento Jun 2017
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 1. Cirrhosis: based on previous liver biopsy if available or based on clinical, imaging. 2. Severe acute hepatitis [14]: fulfilling any 2 of the 3 criteria: * Hepatic encephalopathy, * Serum bilirubin equal to or more than 10 mg/dl * International normalized ratio (INR) more than or equal to 1.6 3. Acute on chronic liver failure [3]: Acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5mg/dL) and coagulopathy (INR ≥ 1.5), complicated within 4 weeks by ascites and/or encephalopathy in patients with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality. 4. Acute deterioration of decompensated cirrhosis [4]: Acute decompensation of cirrhosis in the form of one or more major complications of liver disease, including ascites, hepatic encephalopathy, gastrointestinal bleeding.

Who may be able to join

All consecutive patients presenting to hospital with bilirubin ≥5 and INR≥1.5
Cirrhosis with or without Decompensation presenting with acute deterioration in less than 3 month

Who cannot join

Cirrhosis with chronic decompensation.
Patient on anticoagulant
Hepatocellular carcinoma
Septic shock
Post-liver transplant or resection

Trial locations and contacts

1 site in 1 country.

India1 site

Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070

Other trials in India

About this study

Conditions: Cirrhosis
Medical subject headings: Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02465619
Study group	Role	What they receive
Severe acute hepatitis		Severe acute hepatitis without ascites.
Non-cirrhotic		Not described
Cirrhotic patients with ascites		Not described
decompensated cirrhosis		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Survival
Measured: 28 days

Secondary outcomes (6)

Survival
Measured: 3 months
total number of patients underwent Transplantation
Measured: 3 months
Mortality
Measured: 3 months
Number of patients develop liver failure.
Measured: 3 months
Number of patients develop SIRS (Systemic Inflammatory Response Syndrome).
Measured: 3 months
Number of patients develop sepsis.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

?Jun 2017

First posted8 Jun 2015 (estimated)
Primary completionJun 2017 (estimated)
Study completionJun 2017 (estimated)

Why it stopped: Due to lack of funds

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CirrhosisStudies of the same condition, open and under way.
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: Case only
Time perspective: Prospective
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02465619
Sponsor's protocol ID: ILBS-Cirrhosis-002
Status last verified: Jan 2017
First submitted: 4 Jun 2015
Last updated: 28 Nov 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 2/3
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Primary Biliary Cholangitis (PBC)
Not yet recruiting
Prickly Pear Pulp Powder Along With an Anti-inflammatory Diet in Patients Having Liver Fibrosis
Lipid Profile, Blood Glucose
Active, not recruitingPhase 2/3
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
Primary Biliary Cholangitis
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis

All Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Study and Compare the Clinical Course and Development of Organ Failure in Severe Acute Hepatitis Without Ascites, Non-cirrhotic and Cirrhotic Patients With Ascites [Acute on Chronic Liver Failure] and Acute Deterioration of Previously Decompensated Cirrhosis.
ClinicalTrials.gov ID: NCT02465619
Acronym / sponsor ID: ILBS-Cirrhosis-002
Conditions: Cirrhosis
Study type: Observational
Recruitment status: WithdrawnReason stopped: Due to lack of funds
Enrolment: 0 participants (actual)
Lead sponsor: Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
Primary completion: Jun 2017 (estimated)
Study completion: Jun 2017 (estimated)
First posted: 8 Jun 2015 (estimated)
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

Observational model: Case only
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Severe acute hepatitis	–	–Severe acute hepatitis without ascites.
Non-cirrhotic	–	–
Cirrhotic patients with ascites	–	–
decompensated cirrhosis	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 1. Cirrhosis: based on previous liver biopsy if available or based on clinical, imaging. 2. Severe acute hepatitis [14]: fulfilling any 2 of the 3 criteria: * Hepatic encephalopathy, * Serum bilirubin equal to or more than 10 mg/dl * International normalized ratio (INR) more than or equal to 1.6 3. Acute on chronic liver failure [3]: Acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5mg/dL) and coagulopathy (INR ≥ 1.5), complicated within 4 weeks by ascites and/or encephalopathy in patients with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality. 4. Acute deterioration of decompensated cirrhosis [4]: Acute decompensation of cirrhosis in the form of one or more major complications of liver disease, including ascites, hepatic encephalopathy, gastrointestinal bleeding.

Key inclusion criteria (2 listed)

All consecutive patients presenting to hospital with bilirubin ≥5 and INR≥1.5
Cirrhosis with or without Decompensation presenting with acute deterioration in less than 3 month

Key exclusion criteria (5 listed)

Cirrhosis with chronic decompensation.
Patient on anticoagulant
Hepatocellular carcinoma
Septic shock
Post-liver transplant or resection

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

Survival
Time frame: 28 days

6 secondary outcomes

Survival
Time frame: 3 months
total number of patients underwent Transplantation
Time frame: 3 months
Mortality
Time frame: 3 months
Number of patients develop liver failure.
Time frame: 3 months
Number of patients develop SIRS (Systemic Inflammatory Response Syndrome).
Time frame: 3 months
Number of patients develop sepsis.
Time frame: 3 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.

Related trials for Cirrhosis

Enrolling by invitationPhase 2/3
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Primary Biliary Cholangitis (PBC)
Not yet recruiting
Prickly Pear Pulp Powder Along With an Anti-inflammatory Diet in Patients Having Liver Fibrosis
Lipid Profile, Blood Glucose
Active, not recruitingPhase 2/3
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
Primary Biliary Cholangitis
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis

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.

The record lists no contact. Use the official record to reach the sponsor.

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 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 2 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: withdrawn, as of the sponsor's last update on 28 Nov 2017. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02465619.

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 28 Nov 2017.