A Phase 4 interventional study of Telbivudine and Lamivudine in Hepatitis B Infection, Chronic Infection and Viremia, sponsored by Hua Zhang. Completed. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2013-07-30.
Sponsored by Hua Zhang · Phase 4, Interventional, and Prevention
To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.
Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug use in pregnancy will be evaluated prospectively in this study.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's enrollment of 700 is above the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Hua Zhang is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
HBeAg+CHB pregnant woman gestational age 28 weeks >log10 copies/ml
Exclusion Criteria:
co-infection with hepatitis A,C,D,E or evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had CHB
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
provide standard of care to mothers and standard immunoprophylaxis to their infants
lamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants
Drug: Lamivudine
Telbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants
Drug: Telbivudine
About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun
About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum
The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants
Time frame: perinatal to 28 weeks after infant delivery
Its efficacy in the reduction of HBV vertical transmission rate
Time frame: perinatal to 28 weeks after infant delivery
Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg
Time frame: perinatal to 28 weeks of postpartum
No study locations are listed for this record.
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Telbivudine · Lamivudine