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Trial record 154 of 315 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Efficacy and Adverse Effects of Nucleoside Analogues (TDF/LDT) in Preventing Mother-to-child Transmission of HBV

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Xingfei Pan, The Third Affiliated Hospital of Guangzhou Medical University
Sponsor:
Information provided by (Responsible Party):
Xingfei Pan, The Third Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT03181607
First received: June 2, 2017
Last updated: June 11, 2017
Last verified: June 2017
  Purpose

Mother-to-Child-Transmission (MTCT) of HBV is the most important route in high endemic countries. Although active-passive immune prophylaxis is generally administrated to infants delivered by HBsAg positive women, there are a lot of people infected with HBV in China. High HBV DNA load (>10^5IU/ml) is the vital cause of MTCT. So some researchers used TDF (tenofovir) or LDT(telbivudine) to treat patients with high HBV DNA load during middle, late pregnancy, in order to decrease MTCT. As a result, some data about it were gradually reported in late years. Recently, American Association for the Study of Liver Diseases, European Association for the Study of Liver Diseases and China guidelines for CHB (chronic hepatitis B) suggest that pregnant women with high HBV DNA load be treated with TDF or LDT at 24-28 weeks of gestation to lower MTCT of HBV.

Although TDF or LDT is classified as pregnancy B drugs by FDA, and many studies report that MTCT rate of HBV decreases after women with high HBV DNA load are administrated with TDF or LDT at 24-28 weeks of gestation, a few birth defects are reported. Furthermore, the long-effect of TDF or LDT on infants remains unclear thoroughly.

Some CHB women had severe liver dysfunction before pregnancy or during pregnancy, and routine liver protection therapy could not effect. Some of them could develop into liver failure, fibrosis, cirrhosis, and even died. Moreover, severe liver dysfunction often leads to adverse effects to pregnant women and fetuses, such as pregnancy failure, lower weight, premature birth, etc. As a result, these women have to accept TDF or LDT before pregnancy, or during early pregnancy. So the long-effect of TDF or LDT on infants needs thoroughly investigating.

Taken together, the investigators will enroll women with chronic HBV infection and evaluate their state of illness. Then the investigators treat participants with TDF or LDT or routine liver protection therapy, and follow up the participants for a long period. The investigators' objectives are as follows:

A, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT between immune-tolerant and immune-active CHB patients.

B, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT during different trimesters of pregnancy.

C, To compare MTCT rate between patients received TDF/LDT therapy and patients without TDF/LDT therapy.

D, To compare MTCT rate and adverse effects between LDT and TDF.


Condition
Chronic Hepatitis b Women

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The 3rd Affiliated Hospital, Guangzhou Medical University

Resource links provided by NLM:


Further study details as provided by Xingfei Pan, The Third Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • The proportion of hepatitis B infections in the infants at 1 year of age [ Time Frame: Between 7-12 months after birth ]
    Testing for HBsAg in the infants between 7 and 12 months of age


Secondary Outcome Measures:
  • The proportion of birth defects in the infants at 1 month age [ Time Frame: From birth to 1 month age ]
    Measuring the number of infants with congenital abnormality

  • Growth parameters of the infants [ Time Frame: From birth to 5 years age ]
    The infants'physical development status (head circumference, weight, and height) is measured and analyzed, respectively. Denver Developmental Screening Test is also analyzed.

  • HBV DNA quantification of mothers [ Time Frame: From time of the inclusion to 5 years. ]
    HBV DNA quantification is detected at 24-28 weeks of gestation, at birth, every 6 month after postpartum.

  • ALT levels of mothers [ Time Frame: From time of the inclusion to 5 years. ]
    ALT levels are measured every month during pregnancy and the first 3 months postpartum, and every 6 month from the fourth month of postpartum.

  • HBeAg conversion rate of mothers [ Time Frame: From time of the inclusion to 5 years. ]
    HBeAg quantification is measured every 6 month.


Estimated Enrollment: 800
Actual Study Start Date: June 9, 2017
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Child-bearing age women with chronic HBV infection, who already become pregnant or plan to become pregnant recently,and visit in our hospital, are enrolled.
Criteria

Inclusion Criteria:

  • Age of 20-40 years.
  • The history of HBV infection ≥6 months.
  • Positive for HBsAg.
  • For immune-tolerant patients, HBV DNA load of ≥ 10^6IU/ml at 24-28 weeks of gestation.
  • For patients already administrated with nucleoside analogues (NA) treatment, the therapy could be not discontinued and TDF or LDT should be used to treat these patients.
  • For patients never administrated with NA treatment, ALT ≥2 times of the upper limit of normal (ULN), HBV DNA load of ≥ 10^4IU/ml (positive for HBeAg) or HBV DNA load of ≥ 10^3IU/ml (negative for HBeAg), traditional protecting liver and reducing enzyme treatment was failed.
  • The good compliance of patients.

Exclusion Criteria:

  • Patients with antibodies against HIV, HCV, HDV, or other forms of chronic liver disease.
  • Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity.
  • Concurrent treatment with nephrotoxic drugs, glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators.
  • Ultra-sonographic evidence of fetal deformity, abnormal fetal development or placental abnormality.
  • Clinical signs of threatened miscarriage.
  • History of complication of pregnancy.
  • Presence of chronic HBV infection in the biologic father.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03181607

Contacts
Contact: Xingfei Pan, Dr. +86 20 81292826 panxing0125@163.com
Contact: Fang He, Dr. +86 20 81292539 hefangjnu@126.com

Locations
China, Guangdong
The 3rd Affiliated Hospital, Guangzhou Medical University Recruiting
Guanzhou, Guangdong, China, 510150
Sponsors and Collaborators
Xingfei Pan
Investigators
Study Director: Xingfei Pan, Dr. The 3rd Affiliated Hospital, Guangzhou Medical University
  More Information

Responsible Party: Xingfei Pan, Vice Director of Infectious diseases, The Third Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT03181607     History of Changes
Other Study ID Numbers: [2017] No.157
Study First Received: June 2, 2017
Last Updated: June 11, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

ClinicalTrials.gov processed this record on August 18, 2017