Efficacy and safety of Pegasys combined with adefovir in the treatment of chronic hepatitis B with HBeAg(+)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000612

Enrollment

Unknown

Registered

2009-09-29

Start date

2010-01-01

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 with HBeAg(+).

Interventions

Group A:Pegasys

Group B:Pegasys combined with adefovir

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-60 yeas, male or female; 2. HBsAg(+), HBeAg(+), Anti-HBe(-) and Anti-HBs(-) > 6 months at least; 3. ALT>2 times of upper limit of noraml(ULN), but=1*10^5copies/ml; 5. Without cirrhosis confirmed by biopsy.

Exclusion criteria

Exclusion criteria: 1. Patients received anti-hapatitis B medication in last 6 months; 2. Patients received anti-virus, anti-cancer and immunological regulation treatment in last 6 months; 3. Pregnant or breast-feeding women; 4. Complicated with active hepatitis A, C, D and HIV infection; 5. History of chronic liver disease except hepatitis; 6. Evidence for liver decompensation (Child-Pugh scores>5); Serum albumin =3 seconds Serum bilirubin > 34 umol/L History of hepatic encephalopathy; History of esophagogastric variceal bleeding; Ascites; 7. Symptoms and signs of (Hepatic Cellular Carcinoma, AFP>=100ng/ml. However if AFP>=20 ng/mL but 1.5 times ULN 11. ANA> 1:100 12. History of severe psychosis, especially depression, serious onset of epilepsy and taking anticonvulsive drugs; 13. History of immunologic diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune haemolytic anaemia, scleroderma and rheumatoid arthritis); 14. Severe cardica and pulmonary dysfunction; 15. Organ transplantation, severe diseases and cancer and other improper situations; 16. History of thyroid diseases with poor control and presenting clinical manifestation; 17. Severe retinopathy or ophthalmopathy related to other diseases (such as hypertension, diabetes, CMV and macular degeneration).

Design outcomes

Primary

Measure	Time frame
HBeAg quantity;HBV DNA quantity;	—

Secondary

Measure	Time frame
ALT recovery rate, negative conversion rate of HBe;	—

Countries

China

Contacts

Public ContactQihuan Xu

xqh0303@yahoo.com.cn+86 13724037332

Outcome results

None listed

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