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

Not Applicable

Completed

• Conditions: Spontaneous Reactivation of Hepatitis B
• Interventions: Drug: Tenofovir; Drug: Tenofovir + Telbivudine

• Registration Number: NCT01732224
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-11
• Study Start: 2012-11
• Study First Submitted: 2012-11-19
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-22
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir + Telbivudine	Tenofovir	Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
Tenofovir	Tenofovir + Telbivudine	In tenofovir arm subjects will receive tenofovir (300 mg) once daily.

Primary Outcome Measures

Name	Time	Method
Survival	1 and 3 months

Secondary Outcome Measures

Name	Time	Method
Alteration of renal functions	1 and 3 months
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

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences (ILBS); 🇮🇳 New Delhi, Delhi, India