Clinical trial NCT02327702: Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients
Official title: Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Pregnancy
Keywords: Hepatitis B, chronic
Emtricitabine
Pregnancy
Lead sponsor: Asian-Pacific Alliance of Liver Disease, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Ditan Hospital
name: Hebei Medical University Pharmaceutical Factory
name: National Health and Family Planning Commission, P.R.China
First posted: 2014-12-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: virological response rate
timeFrame: week 48 after delivery
Secondary outcomes:
measure: HBV DNA decrease level
timeFrame: week 24 and 48 after delivery
measure: virological response rate
timeFrame: week 24 after delivery
measure: biochemical response
timeFrame: week 24 and 48 after delivery
measure: HBeAg loss
timeFrame: week 24 and 48 after delivery
measure: HBeAg seroconversion
timeFrame: week 24 and 48 after delivery
measure: HBeAg reversion
timeFrame: week 24 and 48 after delivery
measure: HBsAg loss
timeFrame: week 24 and 48 after delivery
measure: HBsAg seroconversion
timeFrame: week 24 and 48 after delivery
measure: HBV genetic resistance to emtricitabine
timeFrame: week 24 and 48 after delivery
measure: adverse event
timeFrame: week 24 and 48 after delivery
measure: birth defect in newborns
timeFrame: 0 weeks, week24 and week48 after delivery
measure: HBsAg positive rate in newborns
timeFrame: 0 weeks, week24 and week48 after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Asian Pacific Alliance of Liver Diseases, Beijing
name: Jun Cheng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gish RG, Leung NW, Wright TL, Trinh H, Lang W, Kessler HA, Fang L, Wang LH, Delehanty J, Rigney A, Mondou E, Snow A, Rousseau F. Dose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infection. Antimicrob Agents Chemother. 2002 Jun;46(6):1734-40. doi: 10.1128/AAC.46.6.1734-1740.2002.
citation: Lim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, Lee SS, Chan S, Shiffman ML, Washington MK, Rigney A, Anderson J, Mondou E, Snow A, Sorbel J, Guan R, Rousseau F; Emtricitabine FTCB-301 Study Group. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med. 2006 Jan 9;166(1):49-56. doi: 10.1001/archinte.166.1.49.