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A Two-year Study of Telbivudine in HBeAg Negative Hepatitis (STEN)

Primary Purpose

Hepatitis B, Chronic

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Telbivudine, Adefovir dipivoxil

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring HBV DNA, LdT, ADV, HBeAg negative hepatitis, CHB

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Sites / Locations

The Third Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HBeAg Negative Hepatitis

Arm Description

HBeAg Negative Hepatitis patients.

Outcomes

Primary Outcome Measures

The percentage of patients with undectable HBV DNA

Secondary Outcome Measures

Full Information

NCT ID

NCT01521975

First Posted

January 26, 2012

Last Updated

October 22, 2017

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Collaborators

Guangdong Provincial People's Hospital, Guangzhou 8th People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01521975

Brief Title

A Two-year Study of Telbivudine in HBeAg Negative Hepatitis

Acronym

STEN

Official Title

A Two-year, Open-label, Virological Response Adaptive Design, Multicenter Study to Evaluate Efficacy of Telbivudine in HBeAg Negative Adult CHB Patients With Roadmap Strategy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

January 1, 2011 (Actual)

Primary Completion Date

February 28, 2014 (Actual)

Study Completion Date

May 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Collaborators

Guangdong Provincial People's Hospital, Guangzhou 8th People's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study is an open-label, multicenter, PCR response adaptive clinical study design, with intensification of treatment (addition of adefovir to telbivudine treatment) depending on HBV DNA level at week 24. All patients commence with Telbivudine 600mg daily. At week 24 they will be divided into 2 Groups according to virological response. Patients with PCR detectable HBV DNA will add on ADV(Group I). Patients with PCR undetectable HBV DNA(Group II)will continue telbivudine monotherapy. ADV will not be added on unless viral breakthrough occurs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Chronic

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HBeAg Negative Hepatitis

Arm Type

Experimental

Arm Description

HBeAg Negative Hepatitis patients.

Intervention Type

Drug

Intervention Name(s)

Telbivudine, Adefovir dipivoxil

Other Intervention Name(s)

Sebivo, LDT

Intervention Description

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.

Primary Outcome Measure Information:

Title

The percentage of patients with undectable HBV DNA

Time Frame

at Week 104

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhi-Liang Gao, Prof

Organizational Affiliation

Third Affiliated Hospital, Sun Yat-Sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Third Affiliated Hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510630

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

33287722

Citation

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.

Results Reference

derived

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A Two-year Study of Telbivudine in HBeAg Negative Hepatitis

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