Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B

NCT ID: NCT00646503

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-09-30

Brief Summary

This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

600 mg/day, oral telbivudine for 52 weeks

Group Type: EXPERIMENTAL

Telbivudine

Intervention Type: DRUG

600 mg/day, oral telbivudine for 52 weeks

Interventions

Telbivudine

600 mg/day, oral telbivudine for 52 weeks

Intervention Type: DRUG

Other Intervention Names

SEBIVO; TYZEKA

Eligibility Criteria

Inclusion Criteria

• Patient completed Omnibus study and will be available to immediately rollover into this study without discontinuation of study drug.
• Patient was not discontinued from the previous Omnibus study.
• Male or female, adult patients with CHB (HBeAg positive or HBeAg negative).
• Patient is willing and able to provide written informed consent to participate in the study.
• HBV DNA PCR undetectable in recent 12 months.

Exclusion Criteria

• Pregnant or breastfeeding, or has plan of pregnant during study period.
• Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), r HIV at screening visit.
• Patient needs any anti-HBV treatment combination (add-on therapy) or switch to other anti HBV treatment from Telbivudine at investigator's discretion.
• Patient has any laboratory value abnormality that physicians think he/she may not be suitable to continue the Telbivudine treatment.
• Patient has any clinically significant concurrent severe or unstable disease conditions that physicians think he/she may have any additional risk or not be suitable to participate the study.
• Patient has evidence of renal insufficiency defined as patient requiring dialysis or having an estimated creatinine clearance below 50mL/min, as estimated by the cockcroft-Gault formula.
• Patient is currently abusing alcohol or illicit drugs.
• Patient is enrolled or plans to enroll in another clinical trial of an investigational agent while participating in this study.
• All other treatments for hepatitis B, including commercially available treatments indicated for conditions other than chronic hepatitis B that are being investigated to treat or may have activity against HBV (e.g., ribavirin, famciclovir, ganciclovir, etc.)
• Prolonged use of systemic acyclovir or famciclovir defined as episodic treatment with these agents for periods exceeding 10 days every 3 months, or chronic suppressive therapy.
• Systemic immunomodulators of any type.
• Systemic corticosteroids ( topical and inhaled corticosteroids are permitted).
• Herbal medications known to cause hepatotoxicity (e.g., St. John's Wart, Kava, Jin Bu Huan, Yuzhitang, germander, chaparral, shark cartilage, mistletoe, slim 10, Lipokinetix, etc.).
• Patient has any of the following laboratory values:

• Hemoglobin < 9 g/dL for menor <8 g/dL for women.
• Total WBC <1,500/mm3
• Absolute neutrophil count (ANC)<1,000/mm3
• Platelet count <30,000/mm3
• Serum albumin <2.5g/dL
• Total bilirubin ≥4×ULN
• Serum creatinine >1.5×ULN

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

Novartis Investigative Site

Beijing, , China

Countries

China

References

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.

Reference Type: RESULT

PMID: 26329749 (View on PubMed)

Other Identifiers

CLDT600ACN04

Identifier Type: -

Identifier Source: org_study_id