Phase 4 N=197 Treatment

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

Chronic Hepatitis C · Genotype 1

Bottom Line

View on ClinicalTrials.gov: NCT01405027 ↗

Enrolled (actual)

197

Serious AEs

7.1%

Results posted

Jan 2015

Primary outcome: Primary: Treatment Duration Compliance Rate — 85.4; 83.8 Percentage of compliance — p=0.4864

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Educational Intervention (Procedure); Patient education and management skills training (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Chronic Liver Disease Foundation
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Duration Compliance Rate	85.4; 83.8	0.4864
SECONDARY Drug Exposure	84; 113; 84; 112; 83; 110	—
SECONDARY Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.	48.8; 46.0; 23.8; 26.5; 27.4; 27.4	—
SECONDARY Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)	44.6; 45.5; 42.9; 43.7; 49.2; 49.4	—
SECONDARY Number of Participants With Adverse Events	77; 95	—

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, ribavirin and boceprevir.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01405027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.