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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01544582
First received: February 2, 2012
Last updated: July 28, 2016
Last verified: July 2016
Results First Received: May 24, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hepatitis C Chronic

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 713 Chronic Hepatitis C (CHC) participants included in the study, 679 were included in the Analysis Population and 34 were excluded. The Analysis Population comprised participants receiving Boceprevir plus peginterferon and ribavirin (PR), Telaprevir plus PR, or PR alone.

Reporting Groups
  Description
All Included Participants All CHC genotype-1 participants included in study.
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

Participant Flow for 2 periods

Period 1:   Screening/Eligibility
    All Included Participants   Boceprevir + PR   Telaprevir + PR   PR Alone
STARTED   713   0   0   0 
Analysis Population   679   0   0   0 
COMPLETED   679 [1]   0   0   0 
NOT COMPLETED   34   0   0   0 
Initiated Different CHC Treatment                1                0                0                0 
Eligibility Criteria Not Met                33                0                0                0 
[1] Completed means met criteria for Analysis Population

Period 2:   Analysis Population
    All Included Participants   Boceprevir + PR   Telaprevir + PR   PR Alone
STARTED   0 [1]   298   307   74 
COMPLETED   0   180   205   35 
NOT COMPLETED   0   118   102   39 
Participant Refuses to Continue Study                0                15                17                4 
Physician Decision                0                13                10                9 
Safety Reason                0                33                31                8 
Effectiveness Reason                0                48                29                12 
New Contraindication-Alcohol Abuse                0                0                0                1 
Lost to Follow-up                0                6                6                5 
Bad Tolerance to Treatment                0                0                2                0 
Did Not Meet Inclusion Criteria                0                0                3                0 
Intolerance                0                1                0                0 
Liver Transplantation                0                0                1                0 
No Social Insurance                0                0                1                0 
Poor Adherence                0                0                1                0 
Poor Participant Compliance                0                1                0                0 
Programmed Surgery                0                1                0                0 
Participant in Jail                0                0                1                0 
[1] Analysis Population was grouped into Boceprevir+PR, Telaprevir+PR, or PR Alone



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Boceprevir + PR   Telaprevir + PR   PR Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 298   307   74   679 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.4  (10.3)   50.1  (10.9)   46.3  (11.6)   50.3  (10.8) 
Gender 
[Units: Participants]
       
Female   113   102   25   240 
Male   185   205   49   439 


  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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) ]

3.  Primary:   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) ]

4.  Primary:   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) ]

5.  Primary:   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) ]

6.  Primary:   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) ]

7.  Primary:   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) ]

8.  Primary:   Percentage of Anemia Episodes Managed by at Least One Clinical Intervention   [ Time Frame: Up to 48 weeks of a treatment regimen ]

9.  Primary:   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 ]

10.  Primary:   Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention   [ Time Frame: Up to 48 weeks of a treatment regimen ]

11.  Primary:   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 ]

12.  Primary:   Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention   [ Time Frame: Up to 48 weeks of a treatment regimen ]

13.  Primary:   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 ]

14.  Primary:   Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention   [ Time Frame: Up to 48 weeks of a treatment regimen ]

15.  Primary:   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 ]

16.  Secondary:   Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash   [ Time Frame: Up to 48 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01544582     History of Changes
Other Study ID Numbers: P08518
EP08043.001 ( Other Identifier: Merck Epidemiology Number )
SCH 503034 P08518 ( Other Identifier: Schering Protocol Number )
MK-3034-072 ( Other Identifier: Merck Protocol Number )
Study First Received: February 2, 2012
Results First Received: May 24, 2016
Last Updated: July 28, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices