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Trial record 106 of 314 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Immune Function Status and the Prevalence of Hepatitis in Postpartum Pregnant Women With CHB Infection

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ClinicalTrials.gov Identifier: NCT02886182
Recruitment Status : Recruiting
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To date, several studies have manifested that high levels of adrenal corticosteroids and oestrogen hormones during pregnancy can lead to increased HBV viraemia. These hormonal and immune function status changes can result in minimal fluctuations in liver function tests. Serum alanine aminotransferase (ALT) tends to increase in late pregnancy and the postpartum period. Peripartum hepatitis flares leading to hepatic decompensation have been reported.Therefore, the investigators aim to detect and observe the immune function status and incidence of hepatitis in pregnant women with chronic hepatitis B virus infection in late pregnancy and the postpartum period.To provide a clinical evidence for the administration of chronic hepatitis B virus infection pregnant women.

Condition or disease
Chronic Hepatitis B

Detailed Description:
In this trial, pregnants who were positivity for serum HBsAg for more than 6 months and HBeAg , HBV DNA >106IU/mL, alanine aminotransferase (ALT) below 35 IU/mL (ULN=40IU/mL) and no received nucleoside analogue antiviral therapy were enrolled into group A, In addition ,the CHB infection pregnants with undetectable HBVDNA were enrolled into group B(control group).In which, all pregnants were chronic HBV infection without compensated cirrhosis,hepatic adipose infiltration,ICP, hypertension ,heart disease, postpartum hemorrhage. None of the mothers were co-infected with hepatitis A,C,D,E,or HIV;syphilis, Epstein-Barr virus.Serum HBV DNA load(Roche, Pleasanton, CA, USA), HBsAg/anti-HBs level, HBeAg/anti-HBe routine blood test, liver function, renal function will be tested piror to delivery and postpartum 2,6,12 weeks. plasmacytoid dendritic cells(pDCs) and natural killer(NK)cells,CD4+T cells and regulatory T (Treg) cells were detected by flow cytometry. Plasma cytokines Interferon-alpha 2(IFN-α2) / Interferon-gamma (IFN-γ) / Transforming growth factor beta1 (TGF-β1) / Interleukin-2 (IL-2) / Interleukin-6 (IL-6)/Interleukin-10(IL-10) / Interleukin-17A (IL-17A) / tumor necrosis factor-α1(TNF-α1)were measured by Luminex at the above time point except 2 weeks.

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Immune Function Status and the Prevalence of Hepatitis in Postpartum Pregnant Women With Chronic Hepatitis B Virus Infection
Study Start Date : August 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
group A
pregnants who were positivity for serum HBsAg for more than 6 months and HBeAg , HBV DNA >106IU/mL, alanine aminotransferase (ALT) below 35 IU/mL (ULN=40IU/mL) and no received nucleoside analogue antiviral therapy were enrolled into group A
group B
the CHB infection pregnants with undetectable HBVDNA were enrolled into group B(control group)


Outcome Measures

Primary Outcome Measures :
  1. the change of pDCs/ NK/CD4+T/ Treg cells [ Time Frame: in late pregnancy and postpartum 6,12weeks ]
    the immune function of CHB infecion pregnant women will be evaluated by pDCs/ NK/CD4+T/ Treg cells

  2. the change of IFN-α2 / IFN-γ)/ TGF-β1 /IL-2 / IL-6/ IL-10 / IL-17A / TNF-α1 [ Time Frame: in late pregnancy and postpartum 6,12weeks ]
    the immune function of CHB infecion pregnant women will be evaluated by IFN-α2 / IFN-γ)/ TGF-β1 /IL-2 / IL-6/ IL-10 / IL-17A / TNF-α1


Secondary Outcome Measures :
  1. the change of HBVDNA levels (IU/ML) [ Time Frame: in late pregnancy and postpartum 2,6,12weeks ]
    the prevalence of hepatitis in postpartum pregnant women with chronic hepatitis B virus infection will be evaluated by HBV markers and HBV DNA levels and liver function

  2. the change of ALT levels(U/L) [ Time Frame: in late pregnancy and postpartum 2,6,12weeks ]
    the prevalence of hepatitis in postpartum pregnant women with chronic hepatitis B virus infection will be evaluated by HBV markers and HBV DNA levels and liver function

  3. the change of AST levels(U/L) [ Time Frame: in late pregnancy and postpartum 2,6,12weeks ]
    the prevalence of hepatitis in postpartum pregnant women with chronic hepatitis


Biospecimen Retention:   Samples Without DNA
Keeping the serum samples frozen at - 80℃low temperature refrigerator preservation to detect cytokine by high flux liquid chip technology (Luminex)

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In this trial, pregnants who were positivity for serum HBsAg for more than 6 months and HBeAg , HBV DNA >106IU/mL, alanine aminotransferase (ALT) below 35 IU/mL (ULN=40IU/mL) and no received nucleoside analogue antiviral therapy were enrolled into group A, In addition ,the CHB infection pregnants with undetectable HBVDNA were enrolled into group B(control group).
Criteria

Inclusion Criteria:

  • pregnants who were positivity for serum HBsAg for more than 6 months and HBeAg , HBV DNA >106IU/mL/undetectable HBVDNA ,alanine aminotransferase (ALT) below 35 IU/mL (ULN=40IU/mL) and no received nucleoside analogue antiviral therapy

Exclusion Criteria:

  • compensated cirrhosis,hepatic adipose infiltration,ICP. hypertension ,heart disease. postpartum hemorrhage. pregnants who were co-infected with hepatitis A,C,D,E,or HIV;syphilis,Epstein-Barr virus.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886182


Contacts
Contact: Yao Xie, MD 8610-84322489 xieyao00120184@sina.com

Locations
China, Beijing
Beijing Ditan hospital,Capital Medical University Recruiting
Beijing, Beijing, China, 100015
Contact: Yao Xie, doctor    8613501093293    xieyao00120184@sina.com   
Principal Investigator: Yao Xie, doctor         
Sponsors and Collaborators
Beijing Ditan Hospital
More Information

Responsible Party: Yao Xie, Head of liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT02886182     History of Changes
Other Study ID Numbers: DTXY010
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016

Keywords provided by Yao Xie, Beijing Ditan Hospital:
chronic hepatitis B
pregnancy
Cellular immune response
Clinical implications

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections