drugset / Trial / NCT01732224
To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-11
- Primary completion
- 2014-04
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Telbivudine | Small molecule | 600 mg | — |
| Comparator | Tenofovir | Small molecule | 300 mg | — |