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Trial record 56 of 540 for:    IFNA2 AND RBV

ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (P05632) (ATHENAS)

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ClinicalTrials.gov Identifier: NCT00856024
Recruitment Status : Terminated
First Posted : March 5, 2009
Results First Posted : November 28, 2011
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Hepatitis C, Chronic
Interventions Biological: Peginterferon alfa-2b
Drug: Ribavirin
Enrollment 902
Recruitment Details  
Pre-assignment Details  
Arm/Group Title General Peginterferon + Ribavarin
Hide Arm/Group Description Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
Period Title: Overall Study
Started 902
Completed 902
Not Completed 0
Arm/Group Title General Peginterferon + Ribavarin
Hide Arm/Group Description Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
Overall Number of Baseline Participants 902
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 902 participants
49.9  (9.8)
[1]
Measure Description: Age data were only available for 900 participants
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 902 participants
Female
367
  40.7%
Male
535
  59.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 902 participants
902
1.Primary Outcome
Title Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks
Hide Description The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment.
Time Frame First 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Naïve Participants Re-treatment HIV/Hepatitis C Virus (HCV) Co-infected Participants
Hide Arm/Group Description:
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
Overall Number of Participants Analyzed 669 199 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
98.5
(97.3 to 99.3)
98.5
(95.7 to 99.7)
100.0
(89.7 to 100.0)
2.Secondary Outcome
Title Percent of Participants Who Achieved Rapid Virologic Response (RVR)
Hide Description RVR was defined as HCV RNA negative after 4 weeks of treatment.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with data
Arm/Group Title Naïve Participants Re-treatment HIV/Hepatitis C Virus (HCV) Co-infected Participants
Hide Arm/Group Description:
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
Overall Number of Participants Analyzed 170 48 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
34.7
(27.6 to 42.4)
18.8
(8.9 to 32.6)
0.0
(0.0 to 45.9)
3.Secondary Outcome
Title Percent of Participants Who Achieved Early Virologic Response (EVR)
Hide Description EVR was defined as HCV RNA negative after 12 weeks of treatment.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with data
Arm/Group Title Naïve Participants Re-treatment HIV/Hepatitis C Virus (HCV) Co-infected Participants
Hide Arm/Group Description:
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
Overall Number of Participants Analyzed 118 32 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
67.8
(58.6 to 76.1)
46.9
(29.1 to 65.3)
33.3
(4.3 to 77.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title General Peginterferon + Ribavarin
Hide Arm/Group Description Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
All-Cause Mortality
General Peginterferon + Ribavarin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
General Peginterferon + Ribavarin
Affected / at Risk (%) # Events
Total   11/902 (1.22%)    
Blood and lymphatic system disorders   
ANAEMIA  1  7/902 (0.78%)  7
LEUKOPENIA  1  5/902 (0.55%)  5
NEUTROPENIA  1  4/902 (0.44%)  4
THROMBOCYTOPENIA  1  1/902 (0.11%)  1
Gastrointestinal disorders   
NAUSEA  1  1/902 (0.11%)  1
VOMITING  1  1/902 (0.11%)  1
Infections and infestations   
GASTROENTERITIS  1  1/902 (0.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
General Peginterferon + Ribavarin
Affected / at Risk (%) # Events
Total   658/902 (72.95%)    
Blood and lymphatic system disorders   
ANAEMIA  1  204/902 (22.62%)  205
NEUTROPENIA  1  47/902 (5.21%)  48
Gastrointestinal disorders   
NAUSEA  1  140/902 (15.52%)  141
General disorders   
ASTHENIA  1  180/902 (19.96%)  183
FATIGUE  1  123/902 (13.64%)  124
INFLUENZA LIKE ILLNESS  1  116/902 (12.86%)  117
IRRITABILITY  1  52/902 (5.76%)  53
PYREXIA  1  251/902 (27.83%)  253
Metabolism and nutrition disorders   
DECREASED APPETITE  1  100/902 (11.09%)  101
Musculoskeletal and connective tissue disorders   
MYALGIA  1  129/902 (14.30%)  132
Nervous system disorders   
HEADACHE  1  183/902 (20.29%)  186
Psychiatric disorders   
INSOMNIA  1  54/902 (5.99%)  54
Skin and subcutaneous tissue disorders   
PRURITUS  1  62/902 (6.87%)  62
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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 text of the article that will be submitted to the journal shall be defined in common accord between the Investigators and the Sponsor. The principal investigators also agree to not publish and/or present interim results of the study without due written authorization of the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClincialTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00856024     History of Changes
Other Study ID Numbers: P05632
BR 002-07
First Submitted: March 4, 2009
First Posted: March 5, 2009
Results First Submitted: October 14, 2011
Results First Posted: November 28, 2011
Last Update Posted: July 1, 2015