To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B

Study Overview
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Brief Summary
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The relevant data will be prospectively collected included patient demographics, clinical, all laboratory variables including virological tests, genotyping by direct sequencing, abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not evident whether the underlying liver disease was chronic based on clinical, biochemical, radiological investigations, and upper GI endoscopy. Severity of the liver disease will be assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD) score.

Official Title
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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.

Conditions
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Spontaneous Reactivation of Hepatitis B

Intervention / Treatment
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* Drug: Tenofovir + Telbivudine
* Drug: Tenofovir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tenofovir + Telbivudine<br>Tenofovir (300 mg/day) plus telbivudine (600 mg/day). | Drug: Tenofovir<br>* In tenofovir arm subjects will receive tenofovir (300 mg) once daily.<br>|
| Active Comparator: Tenofovir<br>In tenofovir arm subjects will receive tenofovir (300 mg) once daily. | Drug: Tenofovir + Telbivudine<br>* Tenofovir (300 mg/day) plus telbivudine (600 mg/day).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 1 and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in HBV DNA. |  | 7 days, 15 days, 1 month and 3 month | 
| Drug(s) related adverse effects/ side effects |  | 1 and 3 months | 
| Improvement in CTP and MELD scores |  | 1 and 3 months | 
| Alteration of renal functions |  | 1 and 3 months |