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Trial record 59 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria

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ClinicalTrials.gov Identifier: NCT02515279
Recruitment Status : Completed
First Posted : August 4, 2015
Results First Posted : February 10, 2016
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hepatitis C
Interventions Drug: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 463
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants With Hepatitis C
Hide Arm/Group Description All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
Period Title: Overall Study
Started 463
Completed 359
Not Completed 104
Reason Not Completed
Adverse Event             7
Lack of Efficacy             31
Lost to Follow-up             9
Withdrawal by Subject             18
End-of-treatment visit not attended             17
Other             22
Arm/Group Title Participants With Hepatitis C
Hide Arm/Group Description All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
Overall Number of Baseline Participants 463
Hide Baseline Analysis Population Description
All participants who were enrolled in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 463 participants
41.0  (13.3)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 463 participants
Female 151
Male 310
Missing 2
1.Primary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were enrolled in the study.
Arm/Group Title Participants With Hepatitis C
Hide Arm/Group Description:
All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
Overall Number of Participants Analyzed 463
Measure Type: Number
Unit of Measure: percentage of participants
AEs 44.28
SAEs 3.9
2.Primary Outcome
Title Percentage of Participants With End of Treatment Response
Hide Description Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were enrolled in the study. N (Number of participants analysed)=participants who were evaluable for this measure.
Arm/Group Title Participants With Hepatitis C
Hide Arm/Group Description:
All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
Overall Number of Participants Analyzed 446
Measure Type: Number
Unit of Measure: percentage of participants
Participants with negative PCR 83.8
Participants with positive PCR 9.7
3.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 24 (SVR24)
Hide Description Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participant who were enrolled in the study. N=number of participants evaluable for this measure.
Arm/Group Title Participants With Hepatitis C
Hide Arm/Group Description:
All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
Overall Number of Participants Analyzed 144
Measure Type: Number
Unit of Measure: percentage of participants
26.6
Time Frame up to 6 years
Adverse Event Reporting Description All participant who were enrolled in the study.
 
Arm/Group Title Participants With Hepatitis C
Hide Arm/Group Description All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
All-Cause Mortality
Participants With Hepatitis C
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants With Hepatitis C
Affected / at Risk (%)
Total   18/463 (3.89%) 
Blood and lymphatic system disorders   
Anaemia * 1  8/463 (1.73%) 
Leukopenia * 1  3/463 (0.65%) 
Thrombocytopenia * 1  1/463 (0.22%) 
Gastrointestinal disorders   
Diarrhoea * 1  1/463 (0.22%) 
General disorders   
Influenza like illness * 1  4/463 (0.86%) 
Fatigue * 1  2/463 (0.43%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/463 (0.22%) 
Nervous system disorders   
Headache * 1  2/463 (0.43%) 
Psychiatric disorders   
Depression * 1  1/463 (0.22%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia * 1  1/463 (0.22%) 
Skin and subcutaneous tissue disorders   
Drug eruption * 1  1/463 (0.22%) 
Pruritus * 1  1/463 (0.22%) 
Vascular disorders   
Syncope * 1  1/463 (0.22%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Participants With Hepatitis C
Affected / at Risk (%)
Total   148/463 (31.97%) 
Blood and lymphatic system disorders   
Leukopenia * 1  64/463 (13.82%) 
Anaemia * 1  59/463 (12.74%) 
Thrombocytopenia * 1  40/463 (8.64%) 
General disorders   
Fatigue * 1  39/463 (8.42%) 
Psychiatric disorders   
Depression * 1  27/463 (5.83%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  26/463 (5.62%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
The sustained viral response that had to be filled out 6 months (or later) after the end of treatment was documented poorly due to reasons such as participants that were lost to follow-up or the study closure was before the visit date for the SVR.
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02515279     History of Changes
Other Study ID Numbers: ML22273
First Submitted: July 29, 2015
First Posted: August 4, 2015
Results First Submitted: January 12, 2016
Results First Posted: February 10, 2016
Last Update Posted: April 10, 2017