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.
Overview
- Phase
- Not Applicable
- Intervention
- Tenofovir
- Conditions
- Spontaneous Reactivation of Hepatitis B
- Sponsor
- Institute of Liver and Biliary Sciences, India
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Survival
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
- •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.
Arms & Interventions
Tenofovir + Telbivudine
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
Intervention: Tenofovir
Tenofovir
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
Intervention: Tenofovir + Telbivudine
Outcomes
Primary Outcomes
Survival
Time Frame: 1 and 3 months
Secondary Outcomes
- Alteration of renal functions(1 and 3 months)
- 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)