Hepatitis B, Chronic, Pregnancy
Conditions
Keywords
Hepatitis B, chronic, Emtricitabine, Pregnancy
Brief summary
This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.
Detailed description
Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery, which include HBeAg positive and negative patients.
Interventions
DRUGEmtricitabine
emtricitabine were given to each patients at baseline till 48 weeks after delivery
Sponsors
Beijing Ditan Hospital
Hebei Medical University Pharmaceutical Factory
National Health and Family Planning Commission, P.R.China
Asian-Pacific Alliance of Liver Disease, Beijing
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HBsAg positive for more than 6 months * HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml * HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4 * HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml * HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4 * Nucleoside/nucleotide naive patients * Diagnosed as ≥ 12 weeks pregnancy
Exclusion criteria
* Diagnosed HCC with AFP and ultrasound, CT or MRI * Creatine \>130μmol/L or Ccr \< 70mL/min * Hemoglobin \<100g/L * Coinfected with HAV,HEV,HCV,HDV or HIV * ANA \> 1:100 * Uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer * Drug abuse or alcohal addiction * Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine * Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial * Underwent liver transplantation or liver transplantation in schedule * Allergic to nucleoside or nucleotide analogues * Family history of genetic defects disease * Abnormal results in fatal defects screening * HBsAg positive sperm provider pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| virological response rate | week 48 after delivery | HBV DNA \< 500 copies/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| virological response rate | week 24 after delivery | HBV DNA \< 500 copies/ml |
| biochemical response | week 24 and 48 after delivery | ALT normalization |
| HBeAg loss | week 24 and 48 after delivery | HBeAg loss in HBeAg positive group |
| HBeAg seroconversion | week 24 and 48 after delivery | HBeAg seroconversion in HBeAg positive group |
| HBeAg reversion | week 24 and 48 after delivery | HBeAg positive in Baseline HBeAg negativie group patients |
| HBV DNA decrease level | week 24 and 48 after delivery | HBV DNA decrease compared with baseline（log10 copies/ml） |
| HBsAg seroconversion | week 24 and 48 after delivery | HBsAg loss and anti-HBs positive |
| HBV genetic resistance to emtricitabine | week 24 and 48 after delivery | HBV genetic resistance to emtricitabine |
| adverse event | week 24 and 48 after delivery | type and rate of adverse events;type and rate of severe adverse event; |
| birth defect in newborns | 0 weeks, week24 and week48 after delivery | birth defect in newborns |
| HBsAg positive rate in newborns | 0 weeks, week24 and week48 after delivery | HBsAg positive rate in newborns |
| HBsAg loss | week 24 and 48 after delivery | HBsAg loss |
Contacts
Primary ContactJun Cheng, M.D.
Backup ContactSong Yang, M.D.
Outcome results
None listed