Spontaneous Reactivation of Hepatitis B Clinical Trial
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.
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.
| Status | Completed |
| Enrollment | 69 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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: 1. Superinfection with other viruses (hepatitis E, A, D, or C) 2. other causes of chronic liver failure 3. coexistent hepatocellular carcinoma (HCC) 4. portal vein thrombosis 5. coexistent renal impairment 6. pregnancy 7. coinfection with human immunodeficiency virus (HIV) 8. 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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Institute of Liver & Biliary Sciences (ILBS) | New Delhi | Delhi |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Liver and Biliary Sciences, India |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival | 1 and 3 months | Yes | |
| Secondary | Reduction in HBV DNA. | 7 days, 15 days, 1 month and 3 month | No | |
| Secondary | Drug(s) related adverse effects/ side effects | 1 and 3 months | Yes | |
| Secondary | Improvement in CTP and MELD scores | 1 and 3 months | No | |
| Secondary | Alteration of renal functions | 1 and 3 months | No |