NCT01961440

Brief Summary

This research is to establish a simple and practical system to predict the prognosis of sever hepatitis B.Seven factors (level of serum total bilirubin, prothrombin time, severity of hepatic encephalopathy, hepatorenal syndrome,ascites ,infection and size of liver) which were easier to evaluate and more influential, were included to establish a prognosis scoring system.The scorings of a new score system and MELD were graded at the same time in the patients with sever hepatitis B. And then the distribution figures of survival rates and mortality rates were done according to the scores from low to high. The features of distribution figures of two score system in survival rates and mortality rates and significances of clinical application in certain score were interpreted.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

October 11, 2013

Status Verified

September 1, 2013

Enrollment Period

1.2 years

First QC Date

October 9, 2013

Last Update Submit

October 9, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • survival rate

    twelve weeks

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The population from large hospitals will be selected.

You may qualify if:

  • serum hepatitis B surface antigen(HBsAg) positive for at least 6 months;
  • All patients had a poor general condition, manifested as general malaise, fatigue, jaundice and so on;
  • serum T-Bil of 171 mmol/L or more; or serum T-Bil rises 17.1 mmol/L or more per day;

You may not qualify if:

  • superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus;
  • other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis;
  • ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination;
  • decompensated liver cirrhosis;
  • severe bacterial or fungal infections;
  • a history of diabetes or cardiac disease or hypertension or nephrosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 11, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Last Updated

October 11, 2013

Record last verified: 2013-09