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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Spontaneous Reactivation of Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tenofovir + Telbivudine

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

Group Type EXPERIMENTAL

Tenofovir

Intervention Type DRUG

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

Tenofovir

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

Group Type ACTIVE_COMPARATOR

Tenofovir + Telbivudine

Intervention Type DRUG

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

Interventions

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Tenofovir + Telbivudine

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

Intervention Type DRUG

Tenofovir

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No