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Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B

Intervention: Telbivudine 600mg (Drug); Tenofovir disoproxil fumarate 300mg (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: +41613241111

Summary

The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients. The data from the study should allow for the validation of the Roadmap concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative CHB patients. As part of a post-approval commitment to the European Health Authorities, the data will also be used to provide an optimized clinical treatment strategy for better clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from the study will contribute to a better scientific understanding, disease management and treatment of HBeAg negative CHB patients.

Clinical Details

Official title: OPTIMA: A Randomized, Open-label, 156-week Treatment Study to Evaluate the Efficacy and Safety of Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept

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

Primary outcome: the aggregated rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 of Telbivudine (ARM 1) is non-inferior to Tenofovir (ARM 2).

Secondary outcome:

antiviral efficacy by the rate of patients achieving HBV DNA < 300 copies/ml at Week104, and at Week156

antiviral efficacy by serum HBV DNA reduction and time to achieve HBV DNA <300 copies/ml at Week104, and at Week156

rate of HBsAg loss

biochemical efficacy

safety endpoint

eGFR change in telbivudine arm vs tenofovir Arm over the course of the study

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Male or female, at least 18 years of age Documented compensated HBeAg negative CHB defined by all of the following:

- Detectable serum HBsAg at screening visit and at least 6 months prior;

- HBeAg negative at the screening visit with positive HBeAb;

- Serum HBV DNA > 2000 IU/mL Serum ALT level > 1×ULN and <10×ULN at screening visit;

patient with normal ALT ≤1xULN at screening are eligible, with moderate liver inflammation or fibrosis, complensated liver sirrhosis, ALT level >1xULN wtihin last 6 months Exclusion Criteria:

- Co-infected with HCV, HDV or HIV.

- Received treatment of nucleoside or nucleotide drugs at any time

- Received IFN or other immunomodulatory treatment within six months before Screening

- Pregnant or nursing (lactating) women

- Clinical signs/symptoms of hepatic decompensation

- History of myopathy, myositis or persistent muscle weakness

- history of clinical and laboratory evidence of chronic renal insufficency

Locations and Contacts

Novartis Pharmaceuticals, Phone: +41613241111

Novartis Investigative Site, Innsbruck A-6020, Austria; Recruiting

Novartis Investigative Site, Wien 1090, Austria; Recruiting

Novartis Investigative Site, Wien 1160, Austria; Not yet recruiting

Novartis Investigative Site, Sofia 1527, Bulgaria; Recruiting

Novartis Investigative Site, Sofia 1431, Bulgaria; Recruiting

Novartis Investigative Site, Sofia 1407, Bulgaria; Recruiting

Novartis Investigative Site, Sofia 1612, Bulgaria; Recruiting

Novartis Investigative Site, Varna 9010, Bulgaria; Recruiting

Novartis Investigative Site, Düsseldorf 40237, Germany; Not yet recruiting

Novartis Investigative Site, Essen 45147, Germany; Not yet recruiting

Novartis Investigative Site, Frankfurt 60590, Germany; Recruiting

Novartis Investigative Site, Freiburg 79106, Germany; Recruiting

Novartis Investigative Site, Hamburg 20099, Germany; Recruiting

Novartis Investigative Site, Hannover 30625, Germany; Not yet recruiting

Novartis Investigative Site, Heidelberg 69120, Germany; Withdrawn

Novartis Investigative Site, Herne 44623, Germany; Recruiting

Novartis Investigative Site, Köln 50937, Germany; Not yet recruiting

Novartis Investigative Site, Leipzig 04103, Germany; Recruiting

Novartis Investigative Site, Muenchen 81377, Germany; Withdrawn

Novartis Investigative Site, Würzburg 97080, Germany; Recruiting

Novartis Investigative Site, Athens GR 11527, Greece; Recruiting

Novartis Investigative Site, Thessaloniki GR 54636, Greece; Not yet recruiting

Novartis Investigative Site, Palermo 90127, Italy; Withdrawn

Novartis Investigative Site, Moscow 127473, Russian Federation; Recruiting

Novartis Investigative Site, Moscow 119333, Russian Federation; Recruiting

Novartis Investigative Site, Moscow 119992, Russian Federation; Recruiting

Novartis Investigative Site, Moscow 111123, Russian Federation; Recruiting

Novartis Investigative Site, Moscow 129110, Russian Federation; Recruiting

Novartis Investigative Site, Moscow, Russian Federation; Withdrawn

Novartis Investigative Site, Saint-Petersburg 194044, Russian Federation; Recruiting

Novartis Investigative Site, Ankara 06100, Turkey; Withdrawn

Novartis Investigative Site, Ankara 06500, Turkey; Withdrawn

Novartis Investigative Site, Diyarbakir 21280, Turkey; Recruiting

Novartis Investigative Site, Fatih / Istanbul 34098, Turkey; Recruiting

Novartis Investigative Site, Gaziantep 27310, Turkey; Withdrawn

Novartis Investigative Site, Izmir 35040, Turkey; Withdrawn

Novartis Investigative Site, Trabzon 61080, Turkey; Recruiting

Novartis Investigative Site, Malaga, Andalucia 29010, Spain; Withdrawn

Novartis Investigative Site, Caserta, CE 81100, Italy; Terminated

Novartis Investigative Site, Barcelona, Catalunya 08003, Spain; Recruiting

Novartis Investigative Site, Barcelona, Catalunya 08035, Spain; Recruiting

Novartis Investigative Site, Tarragona, Cataluña 43005, Spain; Recruiting

Novartis Investigative Site, Alexandroupolis, GR 68100, Greece; Recruiting

Novartis Investigative Site, Athens, GR 115 21, Greece; Recruiting

Novartis Investigative Site, Thessaloniki, GR 546 39, Greece; Recruiting

Novartis Investigative Site, Majadahonda, Madrid 28222, Spain; Recruiting

Novartis Investigative Site, El Palmar, Murcia 30120, Spain; Withdrawn

Novartis Investigative Site, Padova, PD 35128, Italy; Withdrawn

Novartis Investigative Site, Torino, TO 10126, Italy; Withdrawn

Additional Information

Starting date: March 2011
Last updated: March 4, 2015

Page last updated: August 23, 2015

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