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

NCT02886182 | Unknown

• 1 other identifier: DTXY010
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis B; pregnancy; Cellular immune response; Clinical implications

Outcome Measures

Primary Outcomes (2)

• 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

• the change of IFN-α2 / IFN-γ)/ TGF-β1 /IL-2 / IL-6/ IL-10 / IL-17A / TNF-α1

  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

  in late pregnancy and postpartum 6,12weeks

Secondary Outcomes (3)

• the change of HBVDNA levels (IU/ML)

  in late pregnancy and postpartum 2,6,12weeks

• the change of ALT levels(U/L)

  in late pregnancy and postpartum 2,6,12weeks

• the change of AST levels(U/L)

  in late pregnancy and postpartum 2,6,12weeks

Study Arms (2)

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)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Beijing Ditan hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

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)

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yao Xie, MD

CONTACT

8610-84322489; xieyao00120184@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver diseases center

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 1, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

CN (1)