To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B
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ClinicalTrials.gov Identifier: NCT01732224 |
Recruitment Status
:
Completed
First Posted
: November 22, 2012
Last Update Posted
: March 23, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spontaneous Reactivation of Hepatitis B | Drug: Tenofovir + Telbivudine Drug: Tenofovir | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Randomized Controlled Study to Compare the Efficacy of Combined Tenofovir Plus Telbuvidine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B. |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Tenofovir + Telbivudine
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
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Drug: Tenofovir
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
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Active Comparator: Tenofovir
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
|
Drug: Tenofovir + Telbivudine
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
|
- Survival [ Time Frame: 1 and 3 months ]
- Reduction in HBV DNA. [ Time Frame: 7 days, 15 days, 1 month and 3 month ]
- Drug(s) related adverse effects/ side effects [ Time Frame: 1 and 3 months ]
- Improvement in CTP and MELD scores [ Time Frame: 1 and 3 months ]
- Alteration of renal functions [ Time Frame: 1 and 3 months ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Reactivation of CHB characterized by a rise in ALT level >5 times upper limit of normal along with HBV DNA level >10^5 copies/ mL (> 1.8 X 10^4 IU/mL).
Exclusion Criteria:
- Superinfection with other viruses (hepatitis E, A, D, or C)
- other causes of chronic liver failure
- coexistent hepatocellular carcinoma (HCC)
- portal vein thrombosis
- coexistent renal impairment
- pregnancy
- coinfection with human immunodeficiency virus (HIV)
- patients who had received a previous course of any antiviral, immunomodulator or cytotoxic/immunosuppressive therapy for chronic hepatitis or other illness within at least the preceding 12 months.

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): NCT01732224
India | |
Institute of Liver & Biliary Sciences (ILBS) | |
New Delhi, Delhi, India, 110070 |
Principal Investigator: | Shiv Kumar Sarin, DM | Institute of Liver & Biliary Sciences (ILBS). |
Responsible Party: | Institute of Liver and Biliary Sciences, India |
ClinicalTrials.gov Identifier: | NCT01732224 History of Changes |
Other Study ID Numbers: |
ILBS-HBV Reactivation-01 |
First Posted: | November 22, 2012 Key Record Dates |
Last Update Posted: | March 23, 2016 |
Last Verified: | November 2012 |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
DNA Virus Infections Tenofovir 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 |