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Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir

Information source: Pusan National University Yangsan Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B

Intervention: Telbivudine (Drug); Tenofovir (Drug); Entecavir (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pusan National University Yangsan Hospital

Official(s) and/or principal investigator(s):
Ki Tae Yoon, M.D., Principal Investigator, Affiliation: Pusan National University Yangsan Hospital

Overall contact:
Ki Tae Yoon, M.D., Phone: 82-55-360-2362, Email: ktyoon@pusan.ac.kr

Summary

Oral antiviral drugs which can be given to patients with HBeAg-positive chronic hepatitis B include Lamivudine, Clevudine, Adefovir, Telbivudine, Entecavir and Tenofovir. 2009 American Association for the Study of Liver Disease (AASLD) Treatment Guidelines and 2009 European association for the Study of the Liver (EASL) Treatment Guidelines recommend the administration of Entecavir or Tenofovir with high potency and low resistance. Lamivudine has low antiviral potency and high incidence of mutation in long-term administration compared to Entecavir or Tenofovir. Clevudine causes the elevated creatinine kinase (CK), side effects including myositis/myopathy and much mutation in the long-term administration. Globe study demonstrated Telbivudine had more excellent antiviral potency than Lamivudine, which was also comparable to or higher than Entecavir or Tenofovir. Nevertheless, the choice of treatment drugs can be limited due to the mutation rate of 25% for 2 years. However, the analysis of Globe study results showed that 2-year treatment progress was very good in patient who showed virologic response at 24 weeks after the initiation of treatment and that high antiviral potency and low mutation rate were observed when the Telbivudine roadmap strategy (in the event that virologic response is shown at 24 weeks, telbivudine monotherapy is maintained and in the event that virologic response is not shown, tenofovir add-on therapy is done) recently implemented and announced in 2011 Asian Pacific Association for the Study of the Liver (APASL) was applied. However, the study was single arm study, which restricted the comparison between Entecavir and Tenofovir monotherapy groups. Therefore, this study intends to compare the anti-viral effect and mutation rate between Entecavir 0. 5mg monotherapy group and Telbivudine roadmap strategy group in patients with HBeAg-positive chronic hepatitis B through a randomized study.

Clinical Details

Official title: A Randomized, Prospective, Multicenter, Open-label Study to Evaluate the Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir in HBeAg-positive Chronic Hepatitis B Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: HBV DNA non-detectability

Secondary outcome:

HBV DNA non-detectability

Reduction of HBV DNA from baseline

HBeAg loss or HBeAg seroconversion

HBsAg loss or HBsAg seroconversion

ALT normalization

Accumulate rate of Viral breakthrough

Accumulate rate of Biochemical Breakthrough

Accumulate rate of genotypic mutation in HBV

Change of eGFR from baseline

Accumulate rate of CK abnormal elevation

Accumulate rate of symptom related muscular disease

Accumulate rate of Adverse event or serious adverse event

Detailed description: 104 treatment-naïve patients with HBeAg-positive chronic hepatitis B who fulfill the inclusion criteria will be randomized in a 1: 1 ratio to receive either Telbivudine 600mg monotherapy or Entecavir monotherapy with stratification before randomization according to presence of cirrhosis. For Telbivudine group, Telbivudine monotherapy or Tenofovir combined therapy will be done according to virologic response at 24 weeks and the primary study will be completed at Week 48 and treatment response will be analyzed. The treatment will be extended to Week 96 and the secondary analysis will be performed then.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female, at least 18 years of age

- Documented CHB defined by HBsAg or HBeAg positive at least 6 month prior

- HBsAg positive at screening visit

- HBeAg positive and Anti-HBe negative at screening visit

- Serum HBV DNA 20,000~200,000,000 IU/mL as determined by Realtime PCR at screening

visit

- Serum ALT 80~400 IU/mL at screening visit

- Patient is willing and able to comply with the study drug regimen and all other study

requirements

- Patient is willing and able to provide written informed consent to participate in the

study Exclusion Criteria:

- Patient has received interferon, pegylated interferon, nucleoside or nucleotide drugs

at any time

- Patient is co-infected with HCV, HDV, or HIV

- Patient with Child Pugh B or C (Child Pugh score ≥ 7)

- Patient has a history of or clinical signs/symptoms of hepatic decompensation such as

ascites, esophageal variceal bleeding, hepatic encephalopathy

- Patient has any of the following laboratory values at screening visit:

- Hemoglobin <10 g/dL

- Absolute neutrophil count (ANC) <1,500/mm3

- Platelet count <70,000/mm3

- Patient has a history of clinical and laboratory evidence of chronic renal

insufficiency defined as an estimated serum creatinine clearance < 50 mL/min using the MDRD formula at screening visit

- Patient is pregnant or breastfeeding

- Patient with currently abusing illegal drugs or alcohol sufficient

- Patient has organ transplantation

- History of any other acute or chronic medical condition that in the opinion of the

investigator would make the patient unsuitable for inclusion into the study

- Patient has one or more additional known primary or secondary causes of liver

disease, other than CHB, including steatohepatitis and autoimmune hepatitis

- Patient, if AFP is >50ng/mL at screening visit, has image findings suggestive of HCC

at Liver CT or Liver MRI

- Patient with hypersensitivity for study drug

Locations and Contacts

Ki Tae Yoon, M.D., Phone: 82-55-360-2362, Email: ktyoon@pusan.ac.kr

Byung Chul Yoon, Busan, Korea, Republic of; Not yet recruiting
Byung Chul Yoon
Byung Chul Yoon, Principal Investigator

Eun Uk Jung, Busan, Korea, Republic of; Not yet recruiting
Eun Uk Jung
Eun Uk Jung, Principal Investigator

Hyun Young Woo, Busan, Korea, Republic of; Not yet recruiting
Hyun Young Woo
Hyun Young Woo, Principal Investigator

Nae-Yun Heo, Busan, Korea, Republic of; Not yet recruiting
Nae-Yun Heo
Nae-Yun Heo, Principal Investigator

Yang Hyun Baek, Busan, Korea, Republic of; Not yet recruiting
Yang Hyun Baek
Yang Hyun Baek, Principal Investigator

Hyun Jin Jo, Changwon, Korea, Republic of; Not yet recruiting
Hyun Jin Jo
Hyun Jin Jo, Principal Investigator

Byung Seok Kim, Daegu, Korea, Republic of; Not yet recruiting
Byung Seok Kim
Byung Seok Kim, Principal Investigator

Soo Young Park, Daegu, Korea, Republic of; Not yet recruiting
Soo Young Park
Soo Young Park, Principal Investigator

Hyun Ju Min, Jinju, Korea, Republic of; Not yet recruiting
Hyun Ju Min
Hyun Ju Min, Principal Investigator

Ki Tae Yoon, Yangsan, Korea, Republic of; Recruiting
Ki Tae Yoon, M.D., Phone: 82-55-360-2362, Email: ktyoon@pusan.ac.kr
Surin Tak, Phone: 82-55-360-1738, Email: surintak@hanmail.net
Ki Tae Yoon, M.D., Principal Investigator

Additional Information

Starting date: April 2012
Last updated: April 30, 2012

Page last updated: August 23, 2015

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