Clinical trial NCT01544582: Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518)
Official title: An Observational Post-Authorization Safety Study (PASS) of Victrelis™ (Boceprevir) Among Chronic Hepatitis C Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Chronic
Keywords: Pegylated Interferon
boceprevir
telaprevir
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-03-06
Enrollment: 713
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 18 years or older with CHC genotype 1

Brief summary: This is an observational prospective follow-up study to assess the utilization of boceprevir and the management of pre-specified health outcomes of interest (HOIs) under conditions of routine clinical care in participants with chronic hepatitis C (CHC) genotype 1.

As an observational prospective study, this study is not intended to change the participant/physician relationship, nor influence the physician's drug prescription or therapeutic management of the participant. No individual administration of any therapeutic or prophylactic agent is assigned in this protocol, and there are no procedures required as part of this protocol. Physician choice of the drug used to treat the participant is based on clinical judgment alone.


Eligibility criteria: Inclusion Criteria:

* Documented chronic hepatitis C (CHC) genotype-1 infection
* Untreated or failed previous therapy
* Initiated a new treatment regimen after the study implementation date at their site
* Agrees to participate in the study by giving written informed consent

Exclusion Criteria:

* Taking part in a clinical trial or in any study where a participant is receiving care outside of normal clinical practice for Hepatitis C Virus (HCV)

Primary outcomes:
measure: Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern)
timeFrame: Up to 37 months
measure: Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight
timeFrame: Before initiation of CHC treatment (Week 0 baseline)
measure: Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height
timeFrame: Before initiation of CHC treatment (Week 0 baseline)
measure: Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI)
timeFrame: Before initiation of CHC treatment (Week 0 baseline)
measure: Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype
timeFrame: Before initiation of CHC treatment (Week 0 baseline)
measure: Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load
timeFrame: Before initiation of CHC treatment (Week 0 baseline)
measure: Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score
timeFrame: Before initiation of CHC treatment (Week 0 baseline)
measure: Percentage of Anemia Episodes Managed by at Least One Clinical Intervention
timeFrame: Up to 48 weeks of a treatment regimen
measure: Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes
timeFrame: Up to 48 weeks of a treatment regimen
measure: Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention
timeFrame: Up to 48 weeks of a treatment regimen
measure: Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes
timeFrame: Up to 48 weeks of a treatment regimen
measure: Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention
timeFrame: Up to 48 weeks of a treatment regimen
measure: Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes
timeFrame: Up to 48 weeks of a treatment regimen
measure: Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention
timeFrame: Up to 48 weeks of a treatment regimen
measure: Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes
timeFrame: Up to 48 weeks of a treatment regimen
Secondary outcomes:
measure: Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash
timeFrame: Up to 48 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: