Efficacy and safety of defovir dipivoxil in children with interferon therapy unresponsive and lamivudine- resistance chronic hepatitis B

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONRC-12001924

Enrollment

Unknown

Registered

2012-02-07

Start date

2006-01-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B

Interventions

Adefovir dipivoxil:Adefovir 0.25mg/kg/d,p.o.qd for three years.ADV dose is not to exceed 10 mg/day.

Eligibility

Sex/Gender

All

Age

7 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Diagnose of Chronic hepatitis B; 2. Age =2*upper limit of normal for at least 6 months, TBIL levels were 2*upper limit of normal; 4. HBsAg and HBV-DNA of blood serum have been positive for more than 6 months; 5. interferon therapy unresponsive and lamivudine- resistance chronic hepatitis B; 6. mother-infant transmission; 7. To be willing to assign informed consent and abide by treatment scheme as well as follow-up plan.

Exclusion criteria

Exclusion criteria: 1. Cirrhosis; 2. serum creatinine level>1.5 mg/dl; 3. treatment with immunomodulatory drugs; 4. Current corticosteroid usage; 5. Co-infection with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV; 6. erious concurrent medical illness; 7. evidence of HCC or prior organ transplantation; 8. poor compliance.

Design outcomes

Primary

Measure	Time frame
HBVM;HBVDNA;liver function parameters;kidney function parameters;safety;	—

Countries

China

Contacts

Public ContactHaiying Yu

xuyueyu90@sohu.com+86 025 83626453

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026