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

Chronic Hepatitis B Clinical Trial

Official title:

Immune Function Status and the Prevalence of Hepatitis in Postpartum Pregnant Women With Chronic Hepatitis B Virus Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02886182
• Other study ID #: DTXY010
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2016
• Last updated: August 27, 2016
• Start date: August 2016
• Est. completion date: August 2019

Study information

• Verified date: August 2016
• Source: Beijing Ditan Hospital
• Contact: Yao Xie, MD
• Phone: 8610-84322489
• Email: xieyao00120184[@]sina.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
China	Beijing Ditan hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of pDCs/ NK/CD4+T/ Treg cells	the immune function of CHB infecion pregnant women will be evaluated by pDCs/ NK/CD4+T/ Treg cells	in late pregnancy and postpartum 6,12weeks	Yes
Primary	the change of IFN-a2 / IFN-?)/ TGF-ß1 /IL-2 / IL-6/ IL-10 / IL-17A / TNF-a1	the immune function of CHB infecion pregnant women will be evaluated by IFN-a2 / IFN-?)/ TGF-ß1 /IL-2 / IL-6/ IL-10 / IL-17A / TNF-a1	in late pregnancy and postpartum 6,12weeks	Yes
Secondary	the change of HBVDNA levels (IU/ML)	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	in late pregnancy and postpartum 2,6,12weeks	Yes
Secondary	the change of ALT levels(U/L)	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	in late pregnancy and postpartum 2,6,12weeks	Yes
Secondary	the change of AST levels(U/L)	the prevalence of hepatitis in postpartum pregnant women with chronic hepatitis	in late pregnancy and postpartum 2,6,12weeks	Yes