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To assess sequential pegylated interferon a-2a therapy in Entecavir-treated patients CHB without satisfactory end-point led to HBeAg seroconversion

To assess sequential pegylated interferon a-2a therapy in Entecavir-treated patients CHB without satisfactory end-point led to HBeAg seroconversion

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003734
Enrollment
Unknown
Registered
2013-08-28
Start date
2013-10-01
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

HBV

Interventions

PEG-IFN a-2a group:PEG-IFN a-2a for 48 weeks (with ETV overlapped in
ETV group:PEG-IFN a-2a for 48 weeks (with ETV overlapped in

Sponsors

Guangdong General hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adult patients (18-65 years of age); Received ETV for at least 96 weeks; HBV DNA <500 copies/mL, HBeAg <=100 PEIU/mL and HBsAg<=1000IU/mL; The urine or blood pregnancy test was negative 24 hours before using drug; Patients without cirrhosis on liver biopsy (choice); Willing to accept treatment and Signe informed consent form

Exclusion criteria

Exclusion criteria: Women who are pregnant or breast-feeding; Combined with HAV, HCV, HDV or HIV infection; Decompensated liver disease (Child-Pugh more than five points); Neutrophil count 1.5 ULN; Alcohol and/or drug abuse within half a year of entry; History of severe psychiatric disease or immunologically mediated disease; Bleeding from esophageal varices or other conditions consistent with decompensated liver disease; Severe cardiac or chronic pulmonary disease; Severe seizure disorder or current anticonvulsant use; Active or suspected cancer; History of antineoplastic or immunomodulatory treatment including systemic corticosteroids; Major organ transplantation; thyroid disease; Severe retinopathy and a history of other severe illnesses or conditions.

Design outcomes

Primary

MeasureTime frame
HBeAg seroconversion;

Secondary

MeasureTime frame
HBeAg loss;HBsAg loss;HBsAg loss;HBsAg seroconversion;

Countries

China

Contacts

Public ContactChen Xiaoping

Guangdong General Hospital

xiaopchen2003@aliyun.com+86 18925100882

Outcome results

None listed

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