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

NCT01732224 | Completed

• 1 other identifier: ILBS-HBV Reactivation-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Spontaneous Reactivation of Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Survival

  1 and 3 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Tenofovir + Telbivudine

EXPERIMENTAL

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

Drug: Tenofovir

Tenofovir

ACTIVE COMPARATOR

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

Drug: Tenofovir + Telbivudine

Interventions

Tenofovir + Telbivudine DRUG

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

Tenofovir

Tenofovir DRUG

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

Tenofovir + Telbivudine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Superinfection with other viruses (hepatitis E, A, D, or C)
• other causes of chronic liver failure
• coexistent hepatocellular carcinoma (HCC)
• portal vein thrombosis
• coexistent renal impairment
• pregnancy
• coinfection with human immunodeficiency virus (HIV)
• 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Tenofovir; Telbivudine

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Shiv Kumar Sarin, DM

  Institute of Liver & Biliary Sciences (ILBS).

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 22, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 23, 2016

Record last verified: 2012-11

Locations

IN (1)