Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy

Completed · Phase 4

Conditions studied: Chronic Hepatitis C, Genotype 1

In brief

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, ribavirin and boceprevir.

Key facts

Study ID

NCT01405027

Run by

Chronic Liver Disease Foundation

People needed

197

Starts

2011-12-01

Expected to finish

2014-07-01

Last updated by the study team

2015-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Liver Institute — Beverly Hills, California, United States
• Samuel Burstein, MD — Calabasas, California, United States
• William Katkov, MD — Santa Monica, California, United States
• Sutha Sachar, MD — Torrance, California, United States
• Harbor UCLA Medical Professional Group — Torrance, California, United States
• Associates in Gastroenterology — Colorado Springs, Colorado, United States
• South Denver Gastroenterology — Englewood, Colorado, United States
• Bay Area Gastroenterology — Clearwater, Florida, United States
• Digestive Medicine Associates — Hialeah, Florida, United States
• James Johnson, MD — Lakeland, Florida, United States
• Florida Center for Gastroenterology — Largo, Florida, United States
• Marwan Iskandarani, MD — North Miami Beach, Florida, United States
• Advanced Gastro and Liver Disease — Pinellas Park, Florida, United States
• Lee S. Mitchel, MD — Sarasota, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Digestive Disease Consultants — Bourbonnais, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Consultants in Gastroenerology — Munster, Indiana, United States
• Consultants in Gastroenterology — Munster, Indiana, United States
• Wabash Valley Infectious Disease — Terre Haute, Indiana, United States
• University of Iowa Health Center — Iowa City, Iowa, United States
• Metropolitan Gastroenterology Associates — Metairie, Louisiana, United States
• Henry Ford Health System — Detroit, Michigan, United States
• South Oakland Gastroenterology — Farmington Hills, Michigan, United States
• Union Lake Clinic — Madison Heights, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.