DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

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 (Drug); Adefovir (Drug); Tenofovir (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Novartis Pharmaceuticals

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

Summary

The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.

Clinical Details

Official title: A Prospective, Randomized, Trial to Investigate the Effect of Continued Adefovir Versus Combination Regimens of Telbivudine Plus Adefovir, and Telbivudine Plus Tenofovir in Patients With Chronic Hepatitis B and Suboptimal Viral Suppression (PROACTIV Study)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Documented compensated chronic hepatitis B defined by clinical history compatible

with chronic hepatitis B

- Patient is currently receiving Hepsera (adefovir dipivoxil) and has received

treatment continuously for a minimum of 5 months prior to screening. Other inclusion criteria may apply. Exclusion Criteria:

- Patient is pregnant or breastfeeding

- Patient is co-infected with hepatitis C, hepatitis D or HIV

- Patient previously received nucleoside(tide) therapy other than adefovir

- Patient previously received an interferon-based treatment or an investigational agent

for hepatitis B in the preceding 12 months Other exclusion criteria may apply.

Locations and Contacts

Additional Information


Last updated: March 5, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017