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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Spontaneous Reactivation of Hepatitis B

Treatments: Drug: Tenofovir; Drug: Tenofovir + Telbivudine

Study type: Interventional

Funder types: Other

Identifiers

NCT01732224

ILBS-HBV Reactivation-01

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Tenofovir + Telbivudine

Experimental group

Description:

Tenofovir (300 mg/day) plus telbivudine (600 mg/day).

Treatment:

Drug: Tenofovir

Tenofovir

Active Comparator group

Description:

In tenofovir arm subjects will receive tenofovir (300 mg) once daily.

Treatment:

Drug: Tenofovir + Telbivudine