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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01732224

Enrollment

Registered

2012-11-22

Start date

2012-11-30

Completion date

2014-04-30

Last updated

2016-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Reactivation of Hepatitis B

Brief 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.

Interventions

DRUGTenofovir + Telbivudine

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

DRUGTenofovir

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Survival	1 and 3 months

Secondary

Measure	Time frame
Reduction in HBV DNA.	7 days, 15 days, 1 month and 3 month
Drug(s) related adverse effects/ side effects	1 and 3 months
Improvement in CTP and MELD scores	1 and 3 months
Alteration of renal functions	1 and 3 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026