To Study and Compare the Clinical Course and Development... | NCT02465619

Studies
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.

NCT02465619

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Withdrawn

Last Update Posted

Nov 28, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cirrhosis

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to lack of funds

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Jun 2017Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Jun 4, 2015

First Submission Date that Met QC Criteria

Jun 4, 2015

First Posted Date

Jun 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2017

Last Update Posted Date

Nov 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Measure	Description	Time Frame
Survival		28 days

Measure	Description	Time Frame
Survival		3 months
total number of patients underwent Transplantation		3 months
Mortality

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cirrhosis: based on previous liver biopsy if available or based on clinical, imaging.
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
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.
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.

Sampling Method

Non-Probability Sample

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Label	Type	Description	Intervention Names
Severe acute hepatitis		Severe acute hepatitis without ascites.
Non-cirrhotic
Cirrhotic patients with ascites
decompensated cirrhosis