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

Information source: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spontaneous Reactivation of Hepatitis B

Intervention: Tenofovir + Telbivudine (Drug); Tenofovir (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Institute of Liver and Biliary Sciences, India

Official(s) and/or principal investigator(s):
Shiv Kumar Sarin, DM, Principal Investigator, Affiliation: Institute of Liver & Biliary Sciences (ILBS).

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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Survival

Secondary outcome:

Reduction in HBV DNA.

Drug(s) related adverse effects/ side effects

Improvement in CTP and MELD scores

Alteration of renal functions

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Institute of Liver & Biliary Sciences (ILBS), New Delhi, Delhi 110070, India
Additional Information

Starting date: November 2012
Last updated: May 27, 2015

Page last updated: August 23, 2015

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