Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir (TETRA)
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ClinicalTrials.gov Identifier: NCT01588912 |
Recruitment Status
: Unknown
Verified April 2012 by Ki Tae Yoon, Pusan National University Yangsan Hospital.
Recruitment status was: Recruiting
First Posted
: May 1, 2012
Last Update Posted
: May 2, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis B | Drug: Telbivudine Drug: Tenofovir Drug: Entecavir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 104 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | April 2012 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Telbivudine-Tenofovir roadmap |
Drug: Telbivudine
If virologic response, which means HBV DNA < 50 IU/mL, 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
Other Name: Sebivo
Drug: Tenofovir
If virologic response, which means HBV DNA < 50 IU/mL, 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
Other Name: Viread
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Active Comparator: Entecavir |
Drug: Entecavir
Maintain the entecavir through the study period
Other Name: Baraclude
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- HBV DNA non-detectability [ Time Frame: Week 48 ]Low detection limit of HBV DNA is 50 IU/mL
- HBV DNA non-detectability [ Time Frame: Week 96 ]Low detection limit of HBV DNA is 50 IU/mL
- Reduction of HBV DNA from baseline [ Time Frame: Week 12, 24, 36, 48, 60, 72, 84 & 96 ]
- HBeAg loss or HBeAg seroconversion [ Time Frame: Week 48 & 96 ]
- HBsAg loss or HBsAg seroconversion [ Time Frame: Week 48 & 96 ]
- ALT normalization [ Time Frame: Week 48 & 96 ]
- Accumulate rate of Viral breakthrough [ Time Frame: Week 48 & 96 ]
- Accumulate rate of Biochemical Breakthrough [ Time Frame: Week 48 & 96 ]
- Accumulate rate of genotypic mutation in HBV [ Time Frame: Week 48 & 96 ]
- Change of eGFR from baseline [ Time Frame: Week 12, 24, 36, 48, 60, 72, 84 & 96 ]
- Accumulate rate of CK abnormal elevation [ Time Frame: Week 48 & 96 ]
- Accumulate rate of symptom related muscular disease [ Time Frame: Week 48 & 96 ]
- Accumulate rate of Adverse event or serious adverse event [ Time Frame: Week 48 & 96 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588912
Contact: Ki Tae Yoon, M.D. | 82-55-360-2362 | ktyoon@pusan.ac.kr | |
Contact: Surin Tak | 82-55-360-1738 | surintak@hanmail.net |
Korea, Republic of | |
Byung Chul Yoon | Not yet recruiting |
Busan, Korea, Republic of | |
Contact: Byung Chul Yoon | |
Principal Investigator: Byung Chul Yoon | |
Eun Uk Jung | Not yet recruiting |
Busan, Korea, Republic of | |
Contact: Eun Uk Jung | |
Principal Investigator: Eun Uk Jung | |
Hyun Young Woo | Not yet recruiting |
Busan, Korea, Republic of | |
Contact: Hyun Young Woo | |
Principal Investigator: Hyun Young Woo | |
Nae-Yun Heo | Not yet recruiting |
Busan, Korea, Republic of | |
Contact: Nae-Yun Heo | |
Principal Investigator: Nae-Yun Heo | |
Yang Hyun Baek | Not yet recruiting |
Busan, Korea, Republic of | |
Contact: Yang Hyun Baek | |
Principal Investigator: Yang Hyun Baek | |
Hyun Jin Jo | Not yet recruiting |
Changwon, Korea, Republic of | |
Contact: Hyun Jin Jo | |
Principal Investigator: Hyun Jin Jo | |
Byung Seok Kim | Not yet recruiting |
Daegu, Korea, Republic of | |
Contact: Byung Seok Kim | |
Principal Investigator: Byung Seok Kim | |
Soo Young Park | Not yet recruiting |
Daegu, Korea, Republic of | |
Contact: Soo Young Park | |
Principal Investigator: Soo Young Park | |
Hyun Ju Min | Not yet recruiting |
Jinju, Korea, Republic of | |
Contact: Hyun Ju Min | |
Principal Investigator: Hyun Ju Min | |
Ki Tae Yoon | Recruiting |
Yangsan, Korea, Republic of | |
Contact: Ki Tae Yoon, M.D. 82-55-360-2362 ktyoon@pusan.ac.kr | |
Contact: Surin Tak 82-55-360-1738 surintak@hanmail.net | |
Principal Investigator: Ki Tae Yoon, M.D. |
Principal Investigator: | Ki Tae Yoon, M.D. | Pusan National University Yangsan Hospital |
Responsible Party: | Ki Tae Yoon, Assistant Professor, Pusan National University Yangsan Hospital |
ClinicalTrials.gov Identifier: | NCT01588912 History of Changes |
Other Study ID Numbers: |
CLDT600AKR07T |
First Posted: | May 1, 2012 Key Record Dates |
Last Update Posted: | May 2, 2012 |
Last Verified: | April 2012 |
Keywords provided by Ki Tae Yoon, Pusan National University Yangsan Hospital:
chronic hepatitis B HBeAg positive telbivudine |
tenofovir entecavir roadmap |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
DNA Virus Infections Tenofovir Entecavir Telbivudine Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |