Hepatitis C ChronicNCT01544582

Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518)

An observational study of Hepatitis C Chronic, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C Chronic
How many people: 713 participants
Where: No sites listed yet
Study dates: May 2012to Jul 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adults 18 years or older with CHC genotype 1

Who may be able to join

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

Who cannot join

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)

About this study

Official title: An Observational Post-Authorization Safety Study (PASS) of Victrelis™ (Boceprevir) Among Chronic Hepatitis C Patients

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.

Conditions: Hepatitis C Chronic
Keywords: Pegylated Interferon, boceprevir, telaprevir
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01544582
Study group	Role	What they receive
Boceprevir + PR		CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
Telaprevir + PR		CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
PR Alone		CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern)
The percentage of CHC participants initiating boceprevir plus PR treatment, telaprevir plus PR treatment, or PR treatment alone was determined from a Drug Utilization questionnaire that was administered to physicians using an electronic Case Report Form (eCRF) to collect site level information and reported with 95% confidence intervals.
Measured: Up to 37 months
Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight
Baseline mean weight (standard deviation [SD]) in kilograms (Kg) was recorded from the eCRF.
Measured: Before initiation of CHC treatment (Week 0 baseline)
Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height
Baseline mean height (SD) in centimeters (cm) was recorded from the eCRF.
Measured: Before initiation of CHC treatment (Week 0 baseline)
Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI)
Baseline mean body mass index (SD) in Kg/m^2 was recorded from the eCRF.
Measured: Before initiation of CHC treatment (Week 0 baseline)
Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype
Baseline HCV genotype was recorded from the eCRF and the number of participants who were 1a genotype, 1b genotype, or unknown/other was reported.
Measured: Before initiation of CHC treatment (Week 0 baseline)
Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load
Participant baseline HCV viral load was recorded from the eCRF and categorized as either "Low" (<800,000 IU/mL or <2,000,000 RNA copies/mL) or "High" (≥800,000 IU/mL or ≥2,000,000 RNA copies/mL).
Measured: Before initiation of CHC treatment (Week 0 baseline)
Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score
The Child-Pugh Score is used to determine the prognosis of chronic liver disease, in particular cirrhosis. It is classified into Classes A (best prognosis) to C (worst prognosis). Child-Pugh scores assessed within 3 months before CHC treatment regimen initiation were recorded from the eCRF, and the number of participants who were Grade A, Grade B, Grade C, not assessed, or unknown whether assessed were reported.
Measured: Before initiation of CHC treatment (Week 0 baseline)
Percentage of Anemia Episodes Managed by at Least One Clinical Intervention
Anemia (hemoglobin <10 g/dL) was considered a Health Outcome of Interest (HOI) for this study. Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion, drug dose reduction, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of anemia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.
Measured: Up to 48 weeks of a treatment regimen
Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes
Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion (BT), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). Interventions could be used in combination (e.g. ESA plus blood transfusion) and more than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).
For each CHC treatment exposure group, the percentage of anemia episodes managed by a particular intervention are reported out of the total number of managed anemia episodes with data available for that intervention (i.e. anemia episodes with missing data for an intervention were excluded).
Measured: Up to 48 weeks of a treatment regimen
Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention
Grade 3/4 neutropenia (Grade 3: neutrophil count 0.5 - <0.75 × 10^9/L, Grade 4: <0.5 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 neutropenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.
Measured: Up to 48 weeks of a treatment regimen
Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes
Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use, other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). More than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).
For each CHC treatment exposure group, the percentage of grade 3/4 neutropenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 neutropenia episodes with data available for that intervention (i.e. grade 3/4 neutropenia episodes with missing data for an intervention were excluded).
Measured: Up to 48 weeks of a treatment regimen
Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention
Grade 3/4 thrombocytopenia (Grade 3: platelet count 25 - <50 × 10^9/L, Grade 4: <25 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin, platelet transfusion, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 thrombocytopenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.
Measured: Up to 48 weeks of a treatment regimen
Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes
Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin (TPO), platelet transfusion (PT), other treatment (OT) , and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).
For each CHC treatment exposure group, the percentage of grade 3/4 thrombocytopenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 thrombocytopenia episodes with data available for that intervention (i.e. grade 3/4 thrombocytopenia episodes with missing data for an intervention were excluded).
Measured: Up to 48 weeks of a treatment regimen
Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention
Serious rash was considered a HOI for this study and included rash > 50% of body surface area, rash associated with significant systemic symptoms, or rash resulting in hospitalization or urgent care visit. Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid use, intravenous (IV) and/or oral corticosteroids, emollients/moisturizers, antihistamines, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of serious rash episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.
Measured: Up to 48 weeks of a treatment regimen
Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes
Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid (TC), intravenous (IV) and/or oral (PO) corticosteroids (IV/PO CS), emollients/moisturizers (E/M), antihistamines (AH), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).
For each CHC treatment exposure group, the percentage of serious rash episodes managed by a particular intervention are reported out of the total number of managed serious rash episodes with data available for that intervention (i.e. serious rash episodes with missing data for an intervention were excluded).
Measured: Up to 48 weeks of a treatment regimen

Secondary outcomes (1)

Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash
The incidence (events per 1000 participant-days) of the protocol-defined HOIs (anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash) was calculated over the 48-week period following the start of CHC treatment exposure. All protocol-defined HOIs were taken into account (serious and non-serious HOIs). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The incidence per 1000 participant-days of anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash were reported by CHC treatment group of exposure with 95% confidence intervals.
Measured: Up to 48 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Jul 2015

First posted6 Mar 2012 (estimated)
Study startMay 2012
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C ChronicStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 713 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01544582
Sponsor's protocol ID: P08518
Other IDs: EP08043.001, SCH 503034 P08518, MK-3034-072
Status last verified: Jul 2016
First submitted: 2 Feb 2012
Last updated: 16 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Post-Authorization Safety Study (PASS) of Victrelis™ (Boceprevir) Among Chronic Hepatitis C Patients
ClinicalTrials.gov ID: NCT01544582
Acronym / sponsor ID: P08518
Conditions: Hepatitis C Chronic
Keywords: Pegylated Interferon, boceprevir, telaprevir
Study type: Observational
Recruitment status: Completed
Enrolment: 713 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 6 Mar 2012 (estimated)
Results: Posted 16 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Boceprevir + PR	–	–CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
Telaprevir + PR	–	–CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
PR Alone	–	–CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults 18 years or older with CHC genotype 1

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern)
Time frame: Up to 37 months
The percentage of CHC participants initiating boceprevir plus PR treatment, telaprevir plus PR treatment, or PR treatment alone was determined from a Drug Utilization questionnaire that was administered to physicians using an electronic Case Report Form (eCRF) to collect site level information and reported with 95% confidence intervals.
Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight
Time frame: Before initiation of CHC treatment (Week 0 baseline)
Baseline mean weight (standard deviation [SD]) in kilograms (Kg) was recorded from the eCRF.
Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height
Time frame: Before initiation of CHC treatment (Week 0 baseline)
Baseline mean height (SD) in centimeters (cm) was recorded from the eCRF.
Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI)
Time frame: Before initiation of CHC treatment (Week 0 baseline)
Baseline mean body mass index (SD) in Kg/m^2 was recorded from the eCRF.
Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype
Time frame: Before initiation of CHC treatment (Week 0 baseline)
Baseline HCV genotype was recorded from the eCRF and the number of participants who were 1a genotype, 1b genotype, or unknown/other was reported.
Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load
Time frame: Before initiation of CHC treatment (Week 0 baseline)
Participant baseline HCV viral load was recorded from the eCRF and categorized as either "Low" (<800,000 IU/mL or <2,000,000 RNA copies/mL) or "High" (≥800,000 IU/mL or ≥2,000,000 RNA copies/mL).
Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score
Time frame: Before initiation of CHC treatment (Week 0 baseline)
The Child-Pugh Score is used to determine the prognosis of chronic liver disease, in particular cirrhosis. It is classified into Classes A (best prognosis) to C (worst prognosis). Child-Pugh scores assessed within 3 months before CHC treatment regimen initiation were recorded from the eCRF, and the number of participants who were Grade A, Grade B, Grade C, not assessed, or unknown whether assessed were reported.
Percentage of Anemia Episodes Managed by at Least One Clinical Intervention
Time frame: Up to 48 weeks of a treatment regimen
Anemia (hemoglobin <10 g/dL) was considered a Health Outcome of Interest (HOI) for this study. Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion, drug dose reduction, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of anemia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.
Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes
Time frame: Up to 48 weeks of a treatment regimen
Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion (BT), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). Interventions could be used in combination (e.g. ESA plus blood transfusion) and more than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). For each CHC treatment exposure group, the percentage of anemia episodes managed by a particular intervention are reported out of the total number of managed anemia episodes with data available for that intervention (i.e. anemia episodes with missing data for an intervention were excluded).
Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention
Time frame: Up to 48 weeks of a treatment regimen
Grade 3/4 neutropenia (Grade 3: neutrophil count 0.5 - <0.75 × 10^9/L, Grade 4: <0.5 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 neutropenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.
Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes
Time frame: Up to 48 weeks of a treatment regimen
Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use, other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). More than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). For each CHC treatment exposure group, the percentage of grade 3/4 neutropenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 neutropenia episodes with data available for that intervention (i.e. grade 3/4 neutropenia episodes with missing data for an intervention were excluded).
Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention
Time frame: Up to 48 weeks of a treatment regimen
Grade 3/4 thrombocytopenia (Grade 3: platelet count 25 - <50 × 10^9/L, Grade 4: <25 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin, platelet transfusion, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 thrombocytopenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.
Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes
Time frame: Up to 48 weeks of a treatment regimen
Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin (TPO), platelet transfusion (PT), other treatment (OT) , and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). For each CHC treatment exposure group, the percentage of grade 3/4 thrombocytopenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 thrombocytopenia episodes with data available for that intervention (i.e. grade 3/4 thrombocytopenia episodes with missing data for an intervention were excluded).
Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention
Time frame: Up to 48 weeks of a treatment regimen
Serious rash was considered a HOI for this study and included rash > 50% of body surface area, rash associated with significant systemic symptoms, or rash resulting in hospitalization or urgent care visit. Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid use, intravenous (IV) and/or oral corticosteroids, emollients/moisturizers, antihistamines, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of serious rash episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.
Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes
Time frame: Up to 48 weeks of a treatment regimen
Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid (TC), intravenous (IV) and/or oral (PO) corticosteroids (IV/PO CS), emollients/moisturizers (E/M), antihistamines (AH), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). For each CHC treatment exposure group, the percentage of serious rash episodes managed by a particular intervention are reported out of the total number of managed serious rash episodes with data available for that intervention (i.e. serious rash episodes with missing data for an intervention were excluded).

1 secondary outcome

Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash
Time frame: Up to 48 weeks of treatment

Results and safety

Results posted to the registry on 16 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Included Participants	713	679
Boceprevir + PR	0	0
Telaprevir + PR	0	0
PR Alone	0	0

Primary outcome: Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern)

Time frame: Up to 37 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	All Included Participants n = 679
Initiating Boceprevir + PR Treatment	43.9 (40.1 to 47.7)
Initiating Telaprevir + PR Treatment	45.2 (41.4 to 49.0)
Initiating PR Treatment Alone	10.9 (8.7 to 13.5)

Population analysed: Analysis Population: All CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone.

Primary outcome: Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight

Time frame: Before initiation of CHC treatment (Week 0 baseline). Mean (Standard Deviation). Unit: kilograms (Kg)

Measure	Boceprevir + PR n = 280	Telaprevir + PR n = 280	PR Alone n = 74
Value	77.7 (17.4)	77.0 (15.5)	71.7 (13.7)

Population analysed: Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (weight).

Primary outcome: Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height

Time frame: Before initiation of CHC treatment (Week 0 baseline). Mean (Standard Deviation). Unit: centimeters

Measure	Boceprevir + PR n = 254	Telaprevir + PR n = 238	PR Alone n = 61
Value	170.8 (9.8)	170.8 (8.8)	171.0 (7.5)

Primary outcome: Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI)

Time frame: Before initiation of CHC treatment (Week 0 baseline). Mean (Standard Deviation). Unit: Kg/m^2

Measure	Boceprevir + PR n = 248	Telaprevir + PR n = 233	PR Alone n = 61
Value	26.5 (5.1)	26.5 (4.8)	24.7 (4.2)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 14 days following a 48-week treatment regimen (up to 50 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Boceprevir + PR	58 of 298 (19.5%)	178 of 298 (59.7%)	Not reported
Telaprevir + PR	50 of 307 (16.3%)	173 of 307 (56.4%)	Not reported
PR Alone	8 of 74 (10.8%)	25 of 74 (33.8%)	Not reported

Limitations and caveats (from the sponsor): This was a non-interventional study that collected data on both boceprevir and telaprevir treatment regimens within routine medical practice. No individual administration of any therapeutic or prophylactic agent was assigned in this protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C Chronic, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern) (time frame: Up to 37 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01544582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.