NCT01732224

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spontaneous Reactivation of Hepatitis B

Interventions

Type	Name	Description
DRUG	Tenofovir + Telbivudine	Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
DRUG	Tenofovir	In tenofovir arm subjects will receive tenofovir (300 mg) once daily.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-11-22
• Last updated: 2016-03-23

Locations

1 site across 1 country: India