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HBsAg clearence-directed Personalize Treatment Strategy

HBsAg clearence-directed Personalize Treatment Strategy

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-17012515
Enrollment
Unknown
Registered
2017-08-31
Start date
2017-10-01
Completion date
Unknown
Last updated
2017-09-04

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

Conditions

Chronic Hepatitis B HBeAg negative

Interventions

A:Peg-IFN combine with NA
B:maintain former NA treatment

Sponsors

Beijing You'an Hosipital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: HBeAg negtive CHB according to the 'The guideline of prevention and treatment for chronic hepatitis B_2010 update', and 1) aged 18-60, male/female; 2) former PEG-IFN combine with NA treated for at least 48W, and NA maintain treatment for at least 24W now, superiority group for PEG-IFN(HBsAg=1000IU/ml, DNA<100IU/ml)

Exclusion criteria

Exclusion criteria: 1) co-infection with hepatitis A or C or D or E virus or human immunodeficiency virus; 2) pregnancy or lactation or plan to have child in the near future; 3) serious hepatosis or decompensated liver disease; 4) serious heart disease history, include unstable or uncontrol ed cardiac disease in six months; 5) mental disease or mental disease history; 6) uncontrolled epilepsy; 7) excessive drinking or drug taking; 8) uncontrolled diabetes or hypertension or thyroid disease or retinopathy or autoimmune liver disease,etc; 9) a neutrophil count of less than 110*10^9/L and(or) a platelet count of less than 50*10^9/L before treatment; 10) total bilirubin>51 umol/L (especially indirect bilirubin in the highest flight).

Design outcomes

Primary

MeasureTime frame
HBsAg clearance rate;

Secondary

MeasureTime frame
HBsAg clearance increase rate;HBsAg<10IU/ml increase rate;HBsAg<100IU/ml increase rate;HBsAg;HBsAb;

Countries

China

Contacts

Public ContactXinyue Chen

Beijing You'an Hosipital, Capital Medical University

chenxydoc@163.com+86 010-83997159

Outcome results

None listed

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