NCT01062321

Brief Summary

Hepatitis E virus is a public health problem in several countries of the world where safe drinking water is a problem. HEV is an exclusive cause of epidemic hepatitis in general population. HEV infection occurs most frequently in rainy season. The disease affects mainly young adults in the age of 15-40 years.HEV viral infection is of particular concern in pregnancy. It is a potential disaster for mother and child. HEV infection during pregnancy is fulminant and fatal especially if it occurs in third trimester. The mortality in the second trimester is around 20% and reaches upto 45% in the third trimester.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
491

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 13, 2015

Status Verified

July 1, 2011

Enrollment Period

2.9 years

First QC Date

February 3, 2010

Last Update Submit

April 10, 2015

Conditions

HepatitisCytokinesPregnancy

Keywords

Hepatitis E VirusCytokinesPregnancy

Outcome Measures

Primary Outcomes (1)

  • To correlate the levels of cytokines and its genes polymorphisms with the severity of hepatitis in HEV and non-HEV pregnant women.

    3 years

Secondary Outcomes (1)

  • To correlate the outcome of pregnancy with the levels of maternal cytokines and its genes polymorphisms.

    3 years

Study Arms (1)

Hepatitis-E, Pregnant & Non-pregnant

Pregnant,Acute Viral Hepatitis, Fulminant Hepatic Failure

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women of 18-40 years with jaundice and Healthy pregnant women as controls

You may qualify if:

  • Diagnostic criteria of acute viral hepatitis - Patients having acute self-limited disease and a serum aspartate aminotransferase elevation of at least 5 fold or clinical jaundice or both.
  • Diagnostic criteria of acute liver failure - When after a typical acute onset, the patient becomes deeply jaundiced and goes into hepatic encephalopathy within 4 weeks of the onset of disease with no past history of chronic liver disease.
  • Diagnostic criteria of Hepatitis E infection - The serum sample showing HEV IgM positivity and/or HEV-RNA positivity would be considered as HEV infected cases.

You may not qualify if:

  • \. Patients with co-infection with other hepatitis virus. 2. Patients with any other associated diseases. 3. Patients with history of pre-existing liver disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ashok Kumar

New Delhi, National Capital Territory of Delhi, 110002, India

Location

Related Publications (5)

  • Dahiya M, Kumar A, Kar P, Gupta RK, Kumar A. Acute viral hepatitis in third trimester of pregnancy. Indian J Gastroenterol. 2005 May-Jun;24(3):128-9. No abstract available.

    PMID: 16041115RESULT

  • Beniwal M, Kumar A, Kar P, Jilani N, Sharma JB. Prevalence and severity of acute viral hepatitis and fulminant hepatitis during pregnancy: a prospective study from north India. Indian J Med Microbiol. 2003 Jul-Sep;21(3):184-5.

    PMID: 17643015RESULT

  • Hussaini SH, Skidmore SJ, Richardson P, Sherratt LM, Cooper BT, O'Grady JG. Severe hepatitis E infection during pregnancy. J Viral Hepat. 1997 Jan;4(1):51-4. doi: 10.1046/j.1365-2893.1997.00123.x.

    PMID: 9031065RESULT

  • Navaneethan U, Al Mohajer M, Shata MT. Hepatitis E and pregnancy: understanding the pathogenesis. Liver Int. 2008 Nov;28(9):1190-9. doi: 10.1111/j.1478-3231.2008.01840.x. Epub 2008 Jul 25.

    PMID: 18662274RESULT

  • Barrett S, Collins M, Kenny C, Ryan E, Keane CO, Crowe J. Polymorphisms in tumour necrosis factor-alpha, transforming growth factor-beta, interleukin-10, interleukin-6, interferon-gamma, and outcome of hepatitis C virus infection. J Med Virol. 2003 Oct;71(2):212-8. doi: 10.1002/jmv.10472.

    PMID: 12938195RESULT

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Dr. Ashok Kumar, MD

    Maulana Azad Medical College, New Delhi-110002

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Professor

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 4, 2010

Study Start

August 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 13, 2015

Record last verified: 2011-07

Locations

IN(1)