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Efficacy and safety of Peg-IFNa2a for treatment of childfren with chronic hepatitis B: A multicenter, prospective, control study

Efficacy and safety of Peg-IFNa2a for treatment of childfren with chronic hepatitis B: A multicenter, prospective, control study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17013085
Enrollment
Unknown
Registered
2017-10-23
Start date
2017-10-26
Completion date
Unknown
Last updated
2019-02-25

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

Conditions

CHB(Chronic hepatitis b)

Interventions

Case series:Peg-IFNa2a for treatment

Sponsors

Nanfang hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. Aged 1 to 16 years old, male or female; 2. HBsAg, HBeAg positive for at least 6 months; 3. Serum HBV DNA > 1 × 105IU / ml; 4. ALT level > 2.0 × ULN and <10 × ULN 2 consecutive detection with interval of at least 1 month; 5. No history of antiviral treatment or do not recieve antiviral treatment at least in six months before enrollment of this study.

Exclusion criteria

Exclusion criteria: 1. Was treated by antiviral therapy, or immunomodulatory treatment in 6 months before start of the study; 2. evidence of liver cirrhosis or decompensated liver disease, such as imaging examination suggesting cirrhosis or cirrhosis complications, including jaundice (TBIL> 2 × ULN), ascites, gastrointestinal bleeding, hepatic encephalopathy, spontaneous bacterial Peritonitis; or child-Pugh score grade B or C; co-infection with Hepatitis A, C, D, or HIV; 3. Have comorbidity of other liver disease (such as fatty liver, autoimmune liver disease, metabolic liver disease, etc.); 4. Unable to provide written informed consent.

Design outcomes

Primary

MeasureTime frame
Combined response rate;

Secondary

MeasureTime frame
Clearance of HBsAg;HBsAg seroconversion rate;Clearance of HBeAg;Clearance of HBV DNA;

Countries

China

Contacts

Public ContactKangxian Luo

Nanfang Hospital

luokangxian31@163.com+86 020-61641201,020-61641946

Outcome results

None listed

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