Who is sponsoring OPTIMAL?

OPTIMAL is sponsored by Chronic Liver Disease Foundation.

What condition does OPTIMAL study?

OPTIMAL studies Chronic Hepatitis C, Genotype 1.

What drugs are being tested in OPTIMAL?

Interventions: Educational Intervention, Patient education and management skills training.

What is the status of OPTIMAL?

OPTIMAL is currently COMPLETED.

Last reviewed 2014-12-22 · How we verify

Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program (OPTIMAL)

NCT01405027 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Chronic Liver Disease Foundation
Phase	Phase 4
Status	COMPLETED
Enrolment	197
Start date	2011-12
Completion	2014-07

Conditions

Chronic Hepatitis C
Genotype 1

Interventions

Educational Intervention
Patient education and management skills training

Primary outcomes

Treatment Duration Compliance Rate — End of treatment up to treatment week 48
The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B).

Countries

United States