Status:
COMPLETED
Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy
Lead Sponsor:
Chronic Liver Disease Foundation
Collaborating Sponsors:
SCRI Development Innovations, LLC
Merck Sharp & Dohme LLC
Conditions:
Chronic Hepatitis C
Genotype 1
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated interferon, ...
Detailed Description
The new treatment paradigm for HCV in the era of protease inhibitors will add a level of complexity that was previously not seen with pegylated interferon and ribavirin. In addition to new concepts su...
Eligibility Criteria
Inclusion
- Chronic Hepatitis C (HCV) genotype 1
- Detectable HCV-RNA within 180 days of screening
- Age ≥ 18 years
- Weight \> 40 kg
- Patient and partner(s) must agree to use acceptable methods of contraception
- Written informed consent
Exclusion
- Known co-infection with HIV or HBV
- Previous interferon or ribavirin regimen requiring discontinuation for an adverse event considered related to ribavirin and/or interferon
- Currently taking or planning on taking any prohibited medications
- Evidence of decompensated liver disease including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
- Diabetes and/or hypertension with clinically significant ocular examination findings
- Pre-existing psychiatric condition(s)
- History of severe and uncontrolled psychiatric disorders
- Active alcohol or drug abuse (not including marijuana)
- Pre-existing medical condition that could interfere with the patient's participation in the study
- Chronic obstructive pulmonary disease
- Abnormal lab values
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT01405027
Start Date
December 1 2011
End Date
July 1 2014
Last Update
January 6 2015
Active Locations (43)
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1
California Liver Institute
Beverly Hills, California, United States, 90210
2
Samuel Burstein, MD
Calabasas, California, United States, 91302
3
William Katkov, MD
Santa Monica, California, United States, 90404
4
Sutha Sachar, MD
Torrance, California, United States, 90277