A Two-year Study of Telbivudine in HBeAg Negative Hepatitis

NCT01521975 | Completed Phase 4 DMC

• 1 other identifier: HBeAg negative Roadmap
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an individualized telbivudine treatment roadmap strategy designed to achieve optimal viral suppression and low resistance rate in patients with chronic hepatitis B(CHB), which includes adding ADV treatment at different time points according to individual patient response. China CHB Guidelines (China Medical Association 2010) make impress on and confirm LDT ROADMAP strategy particularly, which may be a large potential to expand the naïve patients. We are lack of optimal model in HBeAg(-). In China HBeAg(-) is around 38% of total CHB patients. In GLOBE study, LdT treatment against HBeAg(-) patients with HBV DNA \<7log showed a good 2 year efficacy, but we still look forward to more efficient treatment and lower resistance rate. This study complies with the principle of individualized therapy recommended and ethical principles. It is expected that this study design with individualized treatment approach may improve efficacy and lower the resistance rates. In addition, it will provide important information on how to bring greater benefits to patients with CHB.

Conditions

Hepatitis B, Chronic

Keywords

HBV DNA; LdT; ADV; HBeAg negative hepatitis; CHB

Outcome Measures

Primary Outcomes (1)

• The percentage of patients with undectable HBV DNA

  at Week 104

Study Arms (1)

HBeAg Negative Hepatitis

EXPERIMENTAL

HBeAg Negative Hepatitis patients.

Drug: Telbivudine, Adefovir dipivoxil

Interventions

Telbivudine, Adefovir dipivoxil DRUG

All patients will take Telbivudine 600 mg PO daily from baseline. Some patients will take Adefovir dipivoxil 10 mg PO daily if they meet the criteria of adding Adefovir dipivoxil.

Also known as: Sebivo, LDT

HBeAg Negative Hepatitis

Eligibility Criteria

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

You may qualify if:

• Detectable serum HBsAg at the Screening visit and at least 6 months prior
• HBeAg negative at Screening visit
• serum HBV DNA level \>2,000 IU/mL at Screening visit
• Elevated serum ALT≥2 ×ULN and \<10×ULN at Screening visit (excluding ALT elevations due to non-HBV reasons such as drug, alcohol etc)

You may not qualify if:

• Patient has a history of clinical signs/symptoms of hepatic decompensation (Child-Pugh Grade B or C) or ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
• Patient has a history of hepatocellular carcinoma (HCC) or suspected symptoms of HCC, such as suspicious foci on imaging studies and/or serum alpha-fetoprotein (AFP)\>50ng/mL.
• Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational before.
• Patient has received IFN or other immunomodulatory treatment within 52 weeks before Screening.
• Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir.
• Patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed.
• Patient has used hepatotoxic drugs within one month.
• Patient has overtaken alcohol (\>40g/day) or abused illicit drugs in recent one year.
• Use of other investigational drugs at the time of enrollment.
• History of hypersensitivity to any of the study drugs (telbivudine or adefovir).
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
• Patient is co-infected with HCV, HDV or HIV.
• Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis).
• History of malignancy of any organ system.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead
• Guangdong Provincial People's Hospital: collaborator
• Guangzhou 8th People's Hospital: collaborator

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Related Publications (1)

• Gan W, Li J, Zhang C, Chen X, Lin C, Gao Z. Efficacy of 104-week Telbivudine-based optimization strategy in patients with HBeAg-negative chronic hepatitis B virus infections. BMC Infect Dis. 2020 Dec 7;20(1):931. doi: 10.1186/s12879-020-05642-y.

  PMID: 33287722 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Telbivudine; adefovir dipivoxil

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Zhi-Liang Gao, Prof

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 31, 2012
• Study Start: January 1, 2011
• Primary Completion: February 28, 2014
• Study Completion: May 30, 2014
• Last Updated: October 24, 2017

Record last verified: 2011-01

Locations

CN (1)