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A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

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ClinicalTrials.gov Identifier: NCT00800735
Recruitment Status : Completed
First Posted : December 2, 2008
Results First Posted : September 13, 2013
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Pegylated-interferon alfa-2a
Drug: Ribavirin
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pegylated-interferon Alfa-2a Plus Ribavirin
Hide Arm/Group Description Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
Period Title: Overall Study
Started 30
Completed 16
Not Completed 14
Reason Not Completed
Administrative/Other             2
Insufficient Therapeutic Response             2
Violation of Selection Criteria at Entry             7
Withdrew Consent             3
Arm/Group Title Pegylated-interferon Alfa-2a Plus Ribavirin
Hide Arm/Group Description Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
48.5  (9.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
18
  60.0%
Male
12
  40.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Black 2
Caucasian 28
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 30 participants
170.0  (7.28)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 30 participants
76.97  (16.146)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 30 participants
26.5  (4.53)
1.Primary Outcome
Title Percentage of Participants Who Experienced at Least 1 Adverse Event.
Hide Description An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame Baseline through 24 weeks after the end of treatment (up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients.
Arm/Group Title Pegylated-interferon Alfa-2a Plus Ribavirin
Hide Arm/Group Description:
Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Percentage of participants
80.0
Time Frame Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Adverse Event Reporting Description Safety population: All enrolled participants.
 
Arm/Group Title Pegylated-interferon Alfa-2a Plus Ribavirin
Hide Arm/Group Description Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
All-Cause Mortality
Pegylated-interferon Alfa-2a Plus Ribavirin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pegylated-interferon Alfa-2a Plus Ribavirin
Affected / at Risk (%)
Total   4/30 (13.33%) 
Eye disorders   
Retinal haemorrhage   1/30 (3.33%) 
Infections and infestations   
Conjunctivitis viral   1/30 (3.33%) 
Laryngitis   1/30 (3.33%) 
Sinusitis   1/30 (3.33%) 
Injury, poisoning and procedural complications   
Arthropod bite   1/30 (3.33%) 
Rib fracture   1/30 (3.33%) 
Investigations   
Prothrombin time prolonged   1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
Haemoptysis   1/30 (3.33%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pegylated-interferon Alfa-2a Plus Ribavirin
Affected / at Risk (%)
Total   23/30 (76.67%) 
Blood and lymphatic system disorders   
Anaemia   4/30 (13.33%) 
Lymphopenia   4/30 (13.33%) 
Endocrine disorders   
Hyperthyroidism   2/30 (6.67%) 
Gastrointestinal disorders   
Dyspepsia   3/30 (10.00%) 
Nausea   8/30 (26.67%) 
Vomiting   3/30 (10.00%) 
General disorders   
Asthenia   5/30 (16.67%) 
Chills   7/30 (23.33%) 
Fatigue   16/30 (53.33%) 
Influenza like illness   5/30 (16.67%) 
Pyrexia   4/30 (13.33%) 
Infections and infestations   
Bronchitis   4/30 (13.33%) 
Sinusitis   2/30 (6.67%) 
Urinary tract infection   2/30 (6.67%) 
Metabolism and nutrition disorders   
Decreased appetite   3/30 (10.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia   4/30 (13.33%) 
Back pain   2/30 (6.67%) 
Myalgia   4/30 (13.33%) 
Nervous system disorders   
Dizziness   2/30 (6.67%) 
Headache   7/30 (23.33%) 
Psychiatric disorders   
Depression   5/30 (16.67%) 
Insomnia   7/30 (23.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough   4/30 (13.33%) 
Dyspnoea   3/30 (10.00%) 
Skin and subcutaneous tissue disorders   
Alopecia   5/30 (16.67%) 
Dry skin   5/30 (16.67%) 
Pruritus   9/30 (30.00%) 
Rash   6/30 (20.00%) 
Indicates events were collected by systematic assessment
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-La Roche
Phone: 800 821-8590
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00800735     History of Changes
Other Study ID Numbers: NV21928
2008-002022-10
First Submitted: October 23, 2008
First Posted: December 2, 2008
Results First Submitted: July 5, 2013
Results First Posted: September 13, 2013
Last Update Posted: October 30, 2013