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Trial record 17 of 540 for:    IFNA2 AND RBV

A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection

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ClinicalTrials.gov Identifier: NCT00192647
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : June 14, 2016
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: PEG-IFN alfa-2a
Drug: Ribavirin
Enrollment 896
Recruitment Details Out of total 896 randomized participants, 25 participants (15 in the induction group and 10 in the standard group) did not receive study drug.
Pre-assignment Details  
Arm/Group Title PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Hide Arm/Group Description Participants received 12 weeks of induction therapy with peginterferon (PEG-IFN) alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment. Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Period Title: Overall Study
Started 448 448
Treated 433 438
Completed 320 302
Not Completed 128 146
Reason Not Completed
Death             1             1
Adverse Event             35             29
Laboratory Test Abnormality             4             2
Insufficient Therapeutic Response             53             83
Entry Criteria Violation             6             6
Protocol Violation             3             1
Refused Treatment/Did not Cooperate             10             8
Failure to Return             11             13
Other/Administrative             5             3
Arm/Group Title PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment Total
Hide Arm/Group Description Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment. Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Total of all reporting groups
Overall Number of Baseline Participants 433 438 871
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) analysis population included all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 433 participants 438 participants 871 participants
43.6  (9.55) 43.3  (9.19) 43.4  (9.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 433 participants 438 participants 871 participants
Female
135
  31.2%
153
  34.9%
288
  33.1%
Male
298
  68.8%
285
  65.1%
583
  66.9%
1.Primary Outcome
Title Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period
Hide Description Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population
Arm/Group Title PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Hide Arm/Group Description:
Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Overall Number of Participants Analyzed 433 438
Measure Type: Number
Unit of Measure: percentage of participants
53 50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a+Ribavirin – Induction Treatment, PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2893
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test stratified by viral load and country
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.88 to 1.52
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period
Hide Description Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.
Time Frame Weeks 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population
Arm/Group Title PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Hide Arm/Group Description:
Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Overall Number of Participants Analyzed 433 438
Measure Type: Number
Unit of Measure: percentage of participants
70 66
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a+Ribavirin – Induction Treatment, PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.91 to 1.63
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Virological Responses Over Time
Hide Description Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.
Time Frame Weeks 4, 8, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population
Arm/Group Title PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Hide Arm/Group Description:
Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Overall Number of Participants Analyzed 433 438
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 36.0 26.3
Week 8 60.5 49.8
Week 12 74.4 61.6
Week 24 75.1 67.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a+Ribavirin – Induction Treatment, PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.68
Confidence Interval (2-Sided) 95%
1.24 to 2.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a+Ribavirin – Induction Treatment, PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Comments Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.64
Confidence Interval (2-Sided) 95%
1.24 to 2.17
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a+Ribavirin – Induction Treatment, PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
1.40 to 2.53
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a+Ribavirin – Induction Treatment, PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.46
Confidence Interval (2-Sided) 95%
1.08 to 1.98
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Relapse of End-of-treatment Virological Response
Hide Description Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.
Time Frame Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population. Here, number of participants analyzed signifies participants who had end of treatment virologic response and had HCV RNA measurement available during follow-up.
Arm/Group Title PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Hide Arm/Group Description:
Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Overall Number of Participants Analyzed 297 280
Measure Type: Number
Unit of Measure: percentage of participants
24 22
5.Secondary Outcome
Title Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response
Hide Description The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.
Time Frame Weeks 4, 12, and 72
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population; participants who did not have an HCV RNA measurement at Week 4 or 12 and at Week 72 were excluded from the analysis. Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.
Arm/Group Title PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Hide Arm/Group Description:
Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Overall Number of Participants Analyzed 416 419
Measure Type: Number
Unit of Measure: percentage of participants
Week 4: PPV (n= 416, 419) 76 80
Week 4: NPV (n= 416, 419) 60 60
Week 12: PPV (n= 412, 413) 66 72
Week 12: NPV (n= 412, 413) 87 87
6.Secondary Outcome
Title Change From Baseline in Log10 HCV RNA Values
Hide Description The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.
Time Frame Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population; Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.
Arm/Group Title PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Hide Arm/Group Description:
Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Overall Number of Participants Analyzed 427 431
Mean (Standard Deviation)
Unit of Measure: Log 10 IU/mL
Baseline (n=427,431) 6.19  (0.72) 6.17  (0.76)
Change at Week 4 (n=410,412) -3.42  (1.59) -2.75  (1.71)
Change at Week 8 (n=399,406) -4.26  (1.36) -3.68  (1.72)
Change at Week 12 (n=406,407) -4.57  (1.21) -4.04  (1.67)
Change at Week 24 (n=369,369) -4.58  (1.37) -4.28  (1.70)
Change at EoT (n=425,426) -4.49  (1.44) -4.13  (1.76)
Time Frame Baseline up to Week 72
Adverse Event Reporting Description Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
 
Arm/Group Title PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Hide Arm/Group Description Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment. Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
All-Cause Mortality
PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   46/433 (10.62%)   45/438 (10.27%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/433 (0.00%)  2/438 (0.46%) 
Autoimmune thrombocytopenia * 1  1/433 (0.23%)  0/438 (0.00%) 
Neutropenia * 1  1/433 (0.23%)  0/438 (0.00%) 
Cardiac disorders     
Acute myocardial infarction * 1  0/433 (0.00%)  1/438 (0.23%) 
Angina pectoris * 1  0/433 (0.00%)  1/438 (0.23%) 
Mitral valve incompetence * 1  0/433 (0.00%)  1/438 (0.23%) 
Ear and labyrinth disorders     
Tympanic membrane perforation * 1  0/433 (0.00%)  1/438 (0.23%) 
Endocrine disorders     
Hyperthyroidism * 1  1/433 (0.23%)  1/438 (0.23%) 
Eye disorders     
Optic Ischaemic Neuropathy * 1  1/433 (0.23%)  0/438 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  0/433 (0.00%)  2/438 (0.46%) 
Colitis * 1  2/433 (0.46%)  0/438 (0.00%) 
Nausea * 1  1/433 (0.23%)  1/438 (0.23%) 
Oesophageal varices haemorrhage * 1  2/433 (0.46%)  0/438 (0.00%) 
Abdominal pain * 1  1/433 (0.23%)  0/438 (0.00%) 
Abdominal strangulated hernia * 1  1/433 (0.23%)  0/438 (0.00%) 
Constipation * 1  0/433 (0.00%)  1/438 (0.23%) 
Diarrhoea * 1  1/433 (0.23%)  0/438 (0.00%) 
Erosive duodenitis * 1  1/433 (0.23%)  0/438 (0.00%) 
Faecaloma * 1  1/433 (0.23%)  0/438 (0.00%) 
Gastric stenosis * 1  1/433 (0.23%)  0/438 (0.00%) 
Gastritis * 1  0/433 (0.00%)  1/438 (0.23%) 
Mallory-Weiss syndrome * 1  0/433 (0.00%)  1/438 (0.23%) 
Varices oesophageal * 1  0/433 (0.00%)  1/438 (0.23%) 
Vomiting * 1  0/433 (0.00%)  1/438 (0.23%) 
General disorders     
Chest pain * 1  0/433 (0.00%)  1/438 (0.23%) 
Non-cardiac chest pain * 1  1/433 (0.23%)  0/438 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/433 (0.23%)  0/438 (0.00%) 
Infections and infestations     
Pneumonia * 1  4/433 (0.92%)  1/438 (0.23%) 
Appendicitis * 1  3/433 (0.69%)  0/438 (0.00%) 
Bronchopneumonia * 1  2/433 (0.46%)  0/438 (0.00%) 
Sepsis * 1  1/433 (0.23%)  1/438 (0.23%) 
Arthritis bacterial * 1  0/433 (0.00%)  1/438 (0.23%) 
Bartholin’s abscess * 1  1/433 (0.23%)  0/438 (0.00%) 
Furuncle * 1  0/433 (0.00%)  1/438 (0.23%) 
Gastroenteritis * 1  1/433 (0.23%)  0/438 (0.00%) 
Klebsiella infection * 1  0/433 (0.00%)  1/438 (0.23%) 
Localised infection * 1  0/433 (0.00%)  1/438 (0.23%) 
Lower respiratory tract infection * 1  0/433 (0.00%)  1/438 (0.23%) 
Osteomyelitis * 1  0/433 (0.00%)  1/438 (0.23%) 
Sinusitis * 1  1/433 (0.23%)  0/438 (0.00%) 
Tonsillitis * 1  0/433 (0.00%)  1/438 (0.23%) 
Urinary tract infection * 1  1/433 (0.23%)  0/438 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose * 1  6/433 (1.39%)  0/438 (0.00%) 
Accident * 1  0/433 (0.00%)  1/438 (0.23%) 
Facial bones fracture * 1  1/433 (0.23%)  0/438 (0.00%) 
Foreign body trauma * 1  0/433 (0.00%)  1/438 (0.23%) 
Multiple injuries * 1  0/433 (0.00%)  1/438 (0.23%) 
Overdose * 1  0/433 (0.00%)  1/438 (0.23%) 
Post procedural haemorrhage * 1  1/433 (0.23%)  0/438 (0.00%) 
Spinal cord injury * 1  1/433 (0.23%)  0/438 (0.00%) 
Investigations     
Heart rate irregular * 1  1/433 (0.23%)  0/438 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus * 1  1/433 (0.23%)  0/438 (0.00%) 
Type 1 diabetes mellitus * 1  0/433 (0.00%)  1/438 (0.23%) 
Type 2 diabetes mellitus * 1  1/433 (0.23%)  0/438 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthropathy * 1  1/433 (0.23%)  0/438 (0.00%) 
Compartment syndrome * 1  0/433 (0.00%)  1/438 (0.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  0/433 (0.00%)  1/438 (0.23%) 
Squamous cell carcinoma * 1  1/433 (0.23%)  0/438 (0.00%) 
Nervous system disorders     
Cognitive disorder * 1  1/433 (0.23%)  1/438 (0.23%) 
Headache * 1  0/433 (0.00%)  1/438 (0.23%) 
Presyncope * 1  0/433 (0.00%)  1/438 (0.23%) 
Syncope * 1  0/433 (0.00%)  1/438 (0.23%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  1/433 (0.23%)  0/438 (0.00%) 
Psychiatric disorders     
Depression * 1  1/433 (0.23%)  3/438 (0.68%) 
Suicide attempt * 1  1/433 (0.23%)  3/438 (0.68%) 
Alcohol withdrawal syndrome * 1  0/433 (0.00%)  1/438 (0.23%) 
Anxiety * 1  1/433 (0.23%)  0/438 (0.00%) 
Delirium * 1  1/433 (0.23%)  0/438 (0.00%) 
Delirium tremens * 1  0/433 (0.00%)  1/438 (0.23%) 
Depression suicidal * 1  1/433 (0.23%)  0/438 (0.00%) 
Suicidal ideation * 1  0/433 (0.00%)  1/438 (0.23%) 
Renal and urinary disorders     
Hypotonic urinary bladder * 1  0/433 (0.00%)  1/438 (0.23%) 
Reproductive system and breast disorders     
Bartholin’s cyst * 1  1/433 (0.23%)  0/438 (0.00%) 
Epididymal cyst * 1  0/433 (0.00%)  1/438 (0.23%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  0/433 (0.00%)  3/438 (0.68%) 
Pleuritic pain * 1  1/433 (0.23%)  1/438 (0.23%) 
Dyspnoea * 1  1/433 (0.23%)  0/438 (0.00%) 
Epistaxis * 1  0/433 (0.00%)  1/438 (0.23%) 
Pharyngeal haemorrhage * 1  1/433 (0.23%)  0/438 (0.00%) 
Pleurisy * 1  1/433 (0.23%)  0/438 (0.00%) 
Pulmonary granuloma * 1  0/433 (0.00%)  1/438 (0.23%) 
Pulmonary sarcoidosis * 1  0/433 (0.00%)  1/438 (0.23%) 
Skin and subcutaneous tissue disorders     
Psoriasis * 1  0/433 (0.00%)  1/438 (0.23%) 
Surgical and medical procedures     
Finger amputation * 1  0/433 (0.00%)  1/438 (0.23%) 
Vascular disorders     
Aortic dissection * 1  1/433 (0.23%)  1/438 (0.23%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-IFN Alfa-2a+Ribavirin – Induction Treatment PEG-IFN Alfa-2a+Ribavirin – Standard Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   428/433 (98.85%)   430/438 (98.17%) 
Blood and lymphatic system disorders     
Anaemia * 1  45/433 (10.39%)  39/438 (8.90%) 
Neutropenia * 1  57/433 (13.16%)  43/438 (9.82%) 
Eye disorders     
Dry eye * 1  32/433 (7.39%)  25/438 (5.71%) 
Vision blurred * 1  44/433 (10.16%)  39/438 (8.90%) 
Gastrointestinal disorders     
Abdominal pain * 1  37/433 (8.55%)  31/438 (7.08%) 
Constipation * 1  22/433 (5.08%)  39/438 (8.90%) 
Diarrhoea * 1  100/433 (23.09%)  76/438 (17.35%) 
Dry mouth * 1  54/433 (12.47%)  44/438 (10.05%) 
Mouth ulceration * 1  43/433 (9.93%)  46/438 (10.50%) 
Nausea * 1  178/433 (41.11%)  168/438 (38.36%) 
Vomiting * 1  49/433 (11.32%)  48/438 (10.96%) 
General disorders     
Asthenia * 1  26/433 (6.00%)  17/438 (3.88%) 
Chills * 1  64/433 (14.78%)  34/438 (7.76%) 
Fatigue * 1  159/433 (36.72%)  174/438 (39.73%) 
Influenza like illness * 1  180/433 (41.57%)  183/438 (41.78%) 
Injection site erythema * 1  44/433 (10.16%)  46/438 (10.50%) 
Injection site reaction * 1  25/433 (5.77%)  23/438 (5.25%) 
Irritability * 1  109/433 (25.17%)  111/438 (25.34%) 
Pyrexia * 1  66/433 (15.24%)  47/438 (10.73%) 
Infections and infestations     
Lower respiratory tract infection * 1  24/433 (5.54%)  15/438 (3.42%) 
Investigations     
Weight decreased * 1  120/433 (27.71%)  87/438 (19.86%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  160/433 (36.95%)  113/438 (25.80%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  82/433 (18.94%)  76/438 (17.35%) 
Back pain * 1  44/433 (10.16%)  39/438 (8.90%) 
Muscle spasms * 1  28/433 (6.47%)  17/438 (3.88%) 
Myalgia * 1  114/433 (26.33%)  97/438 (22.15%) 
Nervous system disorders     
Disturbance in attention * 1  38/433 (8.78%)  46/438 (10.50%) 
Dizziness * 1  84/433 (19.40%)  79/438 (18.04%) 
Dysgeusia * 1  36/433 (8.31%)  31/438 (7.08%) 
Headache * 1  227/433 (52.42%)  208/438 (47.49%) 
Lethargy * 1  134/433 (30.95%)  123/438 (28.08%) 
Memory impairment * 1  23/433 (5.31%)  33/438 (7.53%) 
Psychiatric disorders     
Anxiety * 1  46/433 (10.62%)  43/438 (9.82%) 
Depressed mood * 1  18/433 (4.16%)  24/438 (5.48%) 
Depression * 1  83/433 (19.17%)  82/438 (18.72%) 
Insomnia * 1  195/433 (45.03%)  208/438 (47.49%) 
Mood altered * 1  25/433 (5.77%)  21/438 (4.79%) 
Mood swings * 1  32/433 (7.39%)  41/438 (9.36%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  70/433 (16.17%)  61/438 (13.93%) 
Dyspnoea * 1  39/433 (9.01%)  41/438 (9.36%) 
Dyspnoea exertional * 1  48/433 (11.09%)  30/438 (6.85%) 
Epistaxis * 1  26/433 (6.00%)  19/438 (4.34%) 
Pharyngolaryngeal Pain * 1  28/433 (6.47%)  29/438 (6.62%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  122/433 (28.18%)  99/438 (22.60%) 
Dry skin * 1  76/433 (17.55%)  86/438 (19.63%) 
Pruritus * 1  76/433 (17.55%)  88/438 (20.09%) 
Rash * 1  110/433 (25.40%)  116/438 (26.48%) 
Rash pruritic * 1  24/433 (5.54%)  16/438 (3.65%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
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
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00192647     History of Changes
Other Study ID Numbers: ML17908
First Submitted: September 13, 2005
First Posted: September 19, 2005
Results First Submitted: May 6, 2016
Results First Posted: June 14, 2016
Last Update Posted: August 4, 2016