The efficacy and cellular immune mechanism of NAs in the treatment of patients with chronic hepatitis B after multiple antiviral treatment failures

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OCH-14004224

Enrollment

Unknown

Registered

2014-01-05

Start date

2012-03-01

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

Interventions

A:Oral TDF 300mg/d

B:Oral TDF 300mg/d

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. All selected patients were in accordance with The Guideline of Prevention and Treatment for Chronic Hepatitis B (2010 version) edited by Chinese Society of Hepatology and Chinese Society of Infectious Diseases, Chinese Medical Association; 2. Sign the informed consent, good adherence; 3. For the NA treatment failure screening, patients had either condition of suboptimal response to single ADV treatment for over 48 wks or in association with one of the NA treatments [LAM, telbivudine (LDT), or entecavir (ETV)] over 48 wks with HBV DNA =500 IU/ml, or suboptimal response to single NA treatment (LAM, LDT, or ETV) for 24 wks or in association with ADV treatment over 48 wks with HBV DNA =500 IU/ml.

Exclusion criteria

Exclusion criteria: coinfection with human immunodeficiency virus (HIV) or hepatitis C virus, and history of underlying renal problems.

Design outcomes

Primary

Measure	Time frame
Rate of normalization of HBV-DNA;ALT;HBsAg;HBeAg;drug-resistance mutation site;	—

Secondary

Measure	Time frame
Cr;BUN;BM;	—

Countries

China

Contacts

Public ContactLiu Yingxia

Shenzhen Third People's Hospital

yingxialiu@hotmail.com+86 13603096453

Outcome results

None listed

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