The clinical effects of Purple Dan capsule combine with enticavir in chronic hepatitis B patients with particial response to enticavir

The randomized double-blind parallel controlled study of Purple Dan capsule combine with enticavir in chronic hepatitis B patients with particial response to enticavir

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-17011845

Enrollment

Unknown

Registered

2017-07-03

Start date

2017-07-21

Completion date

Unknown

Last updated

2017-07-10

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

Conditions

chronic hepatitis B

Interventions

Treatment group:enticavir

Treatment group:enticavir combined with Purple Dan capsule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Compliance with diagnostic criteria of chronic hepatitis B with particial response to enticavir; 2. HBeAg positive patients: serum HBsAg and HBeAg positive, anti -Hbe negative patients; 3. Partial responders: initial treatment with entecavir for over 1 years(over 48 weeks) and less than 3 years( less than 144 weeks), and the liver function returned to normal, and HBeAg seroconversion did not occur(HBeAg<100PEIU/ml or 400S/CO), and HBV DNA<103copies/ml; 4. Aged 18~65 years old, men and women; 5. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients combinated with hepatitis induced by other hepadnaviridae virus, fatty hepatitis, drug-induced hepatitis, and autoimmune hepatitis; 2. Patients with grade Child-Pugh C> 12, combinated with hepatic encephalopathy, intractable ascites, bleeding tendency, hepatorenal syndrome, primary liver cancer, patients with severe heart, lung and kidney diseases, or psychotic patients; 3. Patients with elevated AFP, and/or suspected hepatic occupying lesions suggested by liver spleen B-mode ultrasonography or CT; 4. Legally disabled persons, pregnant women or lactating women; 5. Patient with allergies or allergic to a variety of drug.

Design outcomes

Primary

Measure	Time frame
HBsAg;HBsAb;HBeAg;HBeAb;HBcAb;	—

Secondary

Measure	Time frame
ALT;AST;GGT;????;DBIL;	—

Countries

China

Contacts

Public ContactGao Yue-Qiu

Shuguang Hospital Affiliated with Shanghai University of Traditonal Chinese Medicine

gaoyueqiu@126.com+86 021-20256188

Outcome results

None listed

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