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Status unknownNCT01380951Updated Jun 27, 2011

Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)

A Phase 4 interventional study of telbivudine in Liver Cirrhosis and Chronic Hepatitis B, sponsored by The Fifth People's Hospital of Suzhou. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-06-27.

Sponsored by The Fifth People's Hospital of Suzhou · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Read the detailed description

Antiviral therapy on CHB patients with liver cirrhosis is compulsory and effective. Diseases development can be prevented or delayed if the virus is depressed successfully. Lamivudine is often used and usually has good efficacy. However, lamivudine resistance and virus mutation happens a lot. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

02

Conditions studied

  • Liver Cirrhosis
  • Chronic Hepatitis B

Keywords

  • liver cirrhosis
  • chronic hepatitis B
  • antiviral therapy
  • telbivudine
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

This is the only study on the registry with The Fifth People's Hospital of Suzhou as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • liver cirrhosis with CHB
  • without history of antiviral therapy or discontinued antiviral therapy for more than 6 months
  • for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative
  • for patients with uncompensated liver cirrhosis:HBV DNA positive

Exclusion criteria

Exclusion Criteria:

  • coinfection with HCV,HDV and HIV
  • AFP≥100mg/L or HCC diagnosed by iconography
  • with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    telbivudine

    Drug: telbivudine

Interventions

  • Drugtelbivudine

    telbivudine 600mg/d 96 weeks

    Also known as: Sebivo

06

What researchers measure

Primary outcomes

  1. Serum HBV DNA

    serum HBV DNA negativity and decline from baseline at week 48

    Time frame: 48 weeks

Secondary outcomes

  1. Serum HBeAg

    rate of HBeAg seroconversion and HBeAg loss

    Time frame: 48 weeks

  2. Child-pugh score

    the average decline of Child-pugh score at week 48 from baseline

    Time frame: 48 weeks

07

Study locations

1 of 1 sites recruiting
  • the Fifth People's Hospital of Suzhou
    Suzhou, Jiangsu, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01380951
Lead sponsor
The Fifth People's Hospital of Suzhou
First posted
Jun 27, 2011
Start date
May 2011
Primary completion
Dec 2012 (estimated)
Completion
Dec 2013 (estimated)
Last update
Jun 27, 2011

Study contacts

Chuanwu Zhu, Doctor
principal investigator · The Fifth People's Hospital of Suzhou

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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