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Status: Withdrawn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
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