Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B

NCT00877149 | Completed Phase 4

• 1 other identifier: CLDT600ACN04E1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this trial is to provide data of absence of inflammation in patient liver histology after long-term telbivudine treatment and thus help investigators to make a comprehensive judgment on treatment discontinuation in selected patients

Conditions

Compensated Chronic Hepatitis B

Keywords

Chronic HBV

Outcome Measures

Primary Outcomes (1)

• To assess proportion of patients with absence of inflammation in liver biopsy at study entry and combine the histological assessment with serological evaluations.

  Visit 2 (week 1)

Secondary Outcomes (4)

• To assess the HBV DNA PCR negativity at 4th-6th year treatment with telbivudine (LDT), in selected patients who have completed study CLDT600ACN04 and will continue telbivudine treatment

  weeks 1, 24, 52 and 24 weeks post-treatment

• To evaluate the percentage of patients with HBeAg loss and/or gain of detectable level of HBeAb in HBeAg positive CHB at baseline of NV-02B-007 or NV-02B-015 studies

  weeks 24 and 52, 24 weeks post-treatment

• To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion

  weeks 24, 52 and 24 weeks post-treatment

• To evaluate the changes in Knodell inflammatory and fibrosis scores from biopsy at study entry compared to biopsy at baseline of studies NV-02B-007 and NV-02B-015

  Visit 2 (week 1)

Study Arms (1)

A

EXPERIMENTAL

Drug: telbivudine/LDT600

Interventions

telbivudine/LDT600 DRUG

A

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient completed study CLDT600ACN04 study and will be available to immediately rollover into this study without discontinuation of study drug.
• Patient was not discontinued from the previous CLDT600ACN04 study.
• Adult patients with CHB (HBeAg positive or HBeAg negative).
• HBV DNA PCR undetectable in recent 12 months.

You may not qualify if:

• Pregnant or breastfeeding, or has plan of pregnant during study period.
• Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV at screening visit.
• Patient has received within the past 12 months any anti-HBV treatment combination (add-on therapy) or switch to other anti HBV treatment from Telbivudine at investigator's discretion.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Beijing Ditan Hospital

Beijing, China

Location

First Hospital of Peking University

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

Ruijin Hospital, Affiliated to 2nd Medical university

Shanghai, China

Location

Related Publications (1)

• Hou JL, Xu D, Shi G, Wan M, Goodman Z, Tan D, Xie Q, Chen C, Wei L, Niu J, Wang Q, Ren H, Wang Y, Jia J, Bao W, Dong Y, Trylesinski A, Naoumov NV. Long-Term Telbivudine Treatment Results in Resolution of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B. Adv Ther. 2015 Aug;32(8):727-41. doi: 10.1007/s12325-015-0232-2. Epub 2015 Sep 2.

  PMID: 26329749 DERIVED

MeSH Terms

Interventions

Telbivudine

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 7, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2011
• Last Updated: May 4, 2012

Record last verified: 2012-05

Locations

CN (4)