Clinical trial NCT02886182: Immune Function Status and the Prevalence of Hepatitis in Postpartum Pregnant Women With CHB Infection
Official title: Immune Function Status and the Prevalence of Hepatitis in Postpartum Pregnant Women With Chronic Hepatitis B Virus Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Keywords: chronic hepatitis B
pregnancy
Cellular immune response
Clinical implications
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility 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.

Primary outcomes:
measure: the change of pDCs/ NK/CD4＋T/ Treg cells
timeFrame: in late pregnancy and postpartum 6,12weeks
measure: the change of IFN-α2 / IFN-γ)/ TGF-β1 /IL-2 / IL-6/ IL-10 / IL-17A / TNF-α1
timeFrame: in late pregnancy and postpartum 6,12weeks
Secondary outcomes:
measure: the change of HBVDNA levels (IU/ML)
timeFrame: in late pregnancy and postpartum 2,6,12weeks
measure: the change of ALT levels(U/L)
timeFrame: in late pregnancy and postpartum 2,6,12weeks
measure: the change of AST levels(U/L)
timeFrame: in late pregnancy and postpartum 2,6,12weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan hospital,Capital Medical University
state: Beijing
Study officials:
References: