DrugLib.com — Drug Information Portal

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



Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201

Information source: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: pradefovir mesylate (Drug); adefovir dipivoxyl (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Valeant Pharmaceuticals International, Inc.

Official(s) and/or principal investigator(s):
Ralph T. Doyle, Study Director, Affiliation: Valeant Pharmaceuticals International, Inc.

Summary

Compare the long-term safety of pradefovir to adefovir dipivoxyl

Clinical Details

Official title: Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201

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

Primary outcome:

- Safety: Clinical examinations of laboratory tests

- Efficacy: Change in viral load over time

Secondary outcome: - Efficacy: Proportion of patients with undetectable viral load

Detailed description:

- Compare the long-term safety of pradefovir to adefovir dipivoxyl

- Monitor development of resistance

- Evaluate virologic and biochemical response

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients who completed 48 weeks of treatment in study RNA200103-201

Exclusion Criteria:

- Patients who were determined to be treatment failures in study RNA200103-201

- Patients who experienced a serious adverse event judged to be related to study drug

in study RNA200103-201

- Patients with a serum creatinine greater than 2. 0 mg/dl on two consecutive

determinations in study RNA200103-201

Locations and Contacts

Additional Information

Starting date: June 2005
Last updated: June 21, 2012

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