Clincosm LogoSign in Get a demo

A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00394277
Collaborator
(none)
1,175
Enrollment
184
Locations
4
Arms
26
Duration (Months)
6.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1175 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized, Multicenter, Double-blinded, Phase IV Study Evaluating the Efficacy (as Measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys® in Combination With Higher Copegus® Doses in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater Than or Equal to 85 kg
Study Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: PEG-IFN 180 µg + Ribavirin 1200 mg

Drug: peginterferon alfa-2a
180 µg sc weekly for 48 weeks
Other Names:
  • Pegasys

    • Drug: Ribavirin
    1200 mg po daily for 48 weeks
    Other Names:
  • Copegus

    		•
    Experimental: PEG-IFN 180 µg + Ribavirin 1400/1600 mg

    Drug: peginterferon alfa-2a
    180 µg sc weekly for 48 weeks
    Other Names:
  • Pegasys

    • Drug: Ribavirin
    1400-1600 mg po daily for 48 weeks
    Other Names:
  • Copegus

    		•
    Experimental: PEG-IFN 360/180 µg + Ribavirin 1200 mg

    Drug: Ribavirin
    1200 mg po daily for 48 weeks
    Other Names:
  • Copegus

    • Drug: peginterferon alfa-2a
    360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
    Other Names:
  • Pegasys

    		•
    Experimental: PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg

    Drug: peginterferon alfa-2a
    360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
    Other Names:
  • Pegasys

    • Drug: Ribavirin
    1400-1600 mg po daily for 48 weeks
    Other Names:
  • Copegus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) [Week 72]

      SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).

    Secondary Outcome Measures

    1. SVR-24 (Actual Treatment Period) [24 weeks after end of treatment]

      SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.

    2. SVR-12 (Scheduled Treatment Period) [12 weeks after end of treatment]

      SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60).

    3. SVR-12 (Actual Treatment Period) [12 weeks after end of treatment]

      SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult patients, ≥18 years of age

    • CHC infection, genotype 1

    • Hepatitis C virus (HCV) RNA ≥400,000 IU/mL

    • Baseline body weight ≥85 kg

    • Liver biopsy (within 24 months of first dose) with results consistent with CHC

    Exclusion Criteria:

    • Previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors

    • Other forms of liver disease, including liver cancer

    • Human immunodeficiency virus infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35294
    2 Huntsville Alabama United States 35801
    3 Anchorage Alaska United States 99508
    4 Phoenix Arizona United States 85006
    5 Fresno California United States 93721
    6 La Jolla California United States 92037-1030
    7 Lancaster California United States 93534
    8 Los Angeles California United States 90045
    9 Los Angeles California United States 90095
    10 Sacramento California United States 95817
    11 San Diego California United States 92103-8465
    12 San Diego California United States 92105
    13 San Diego California United States 92123
    14 San Diego California United States 92154
    15 San Luis Obispo California United States 93401
    16 San Marcos California United States 92069
    17 Ventura California United States 93003
    18 Aurora Colorado United States 80045
    19 Englewood Colorado United States 80113
    20 Washington District of Columbia United States 20010
    21 Washington District of Columbia United States 20037
    22 Jacksonville Florida United States 32209
    23 Jacksonville Florida United States 32256
    24 Miami Florida United States 33136-1051
    25 North Miami Beach Florida United States 33162
    26 Sarasota Florida United States 34243
    27 Atlanta Georgia United States 30308
    28 Austell Georgia United States 30106
    29 Marietta Georgia United States 30060
    30 Honolulu Hawaii United States 96817
    31 Chicago Illinois United States 60612
    32 Chicago Illinois United States 60637
    33 Winfield Illinois United States 60190
    34 Indianapolis Indiana United States 46202
    35 Des Moines Iowa United States 50312
    36 Iowa City Iowa United States 52242-1081
    37 Iowa City Iowa United States 52246
    38 Louisville Kentucky United States 40202
    39 Baton Rouge Louisiana United States 70805
    40 New Orleans Louisiana United States 70112
    41 Boston Massachusetts United States 02720
    42 Worcester Massachusetts United States 01068
    43 Detroit Michigan United States 48210
    44 Ypsilanti Michigan United States 48197
    45 Plymouth Minnesota United States 55446
    46 Kansas City Missouri United States 64131
    47 St Louis Missouri United States 63104
    48 St Louis Missouri United States 63110
    49 Lebanon New Hampshire United States 03756
    50 Egg Harbour Township New Jersey United States 08234
    51 Vineland New Jersey United States 08360
    52 Bronx New York United States 10467
    53 Manhasset New York United States 11030
    54 New York New York United States 10021
    55 New York New York United States 10029
    56 Rochester New York United States 14618
    57 Williamsville New York United States 14221
    58 Yonkers New York United States 10701
    59 Asheville North Carolina United States 28801
    60 Chapel Hill North Carolina United States 27599-7080
    61 Fayetteville North Carolina United States 28304
    62 Cincinnati Ohio United States 45267
    63 Cleveland Ohio United States 44106
    64 Cleveland Ohio United States 44109
    65 Tulsa Oklahoma United States 74104
    66 Medford Oregon United States 97504
    67 Lancaster Pennsylvania United States 17604-3200
    68 Philadelphia Pennsylvania United States 19104
    69 Philadelphia Pennsylvania United States 19107
    70 Pittsburgh Pennsylvania United States 15213
    71 Cranston Rhode Island United States 02920
    72 Providence Rhode Island United States 02903
    73 Columbia South Carolina United States 29204
    74 Germantown Tennessee United States 38138
    75 West Nashville Tennessee United States 37205
    76 Dallas Texas United States 75203
    77 Dallas Texas United States 75246
    78 Dallas Texas United States 75390-9034
    79 Fort Sam Houston Texas United States 78234-3879
    80 Houston Texas United States 77030
    81 Salt Lake City Utah United States 84121
    82 Annandale Virginia United States 22003
    83 Charlottesville Virginia United States 22906-0013
    84 Chesapeake Virginia United States 23320-1706
    85 Fairfax Virginia United States 22031
    86 Richmond Virginia United States 23249
    87 Seattle Washington United States 98104
    88 Tacoma Washington United States 98405
    89 Vancouver Washington United States 98664
    90 Casper Wyoming United States 82609
    91 Cheyenne Wyoming United States 82001
    92 Bruxelles Belgium 1000
    93 Bruxelles Belgium 1030
    94 Bruxelles Belgium 1070
    95 Bruxelles Belgium 1200
    96 Gent Belgium 9000
    97 Leuven Belgium 3000
    98 Caixa Brazil 18618-970
    99 Campinas Brazil 13083-888
    100 Juiz de Fora Brazil 36036-330
    101 Porto Alegre Brazil 90035-003
    102 Porto Alegre Brazil 91350-200
    103 Salvador Brazil 40110-170
    104 Sao Jose Do Rio Preto Brazil 15090-000
    105 Sao Paulo Brazil 01307
    106 Edmonton Alberta Canada T6G 2B7
    107 Vancouver British Columbia Canada V6Z 2K5
    108 Winnipeg Manitoba Canada R3E 3P4
    109 Halifax Nova Scotia Canada B3H 1V7
    110 London Ontario Canada N6A 5A5
    111 Ottawa Ontario Canada K1H 8L6
    112 Toronto Ontario Canada M5G 1L7
    113 Toronto Ontario Canada M5G 1X5
    114 Toronto Ontario Canada M6H 3M1
    115 Montreal Quebec Canada H1T 2M4
    116 Kolding Denmark 6000
    117 Odense Denmark 5000
    118 Clermont-ferrand France 63000
    119 Clichy France 92118
    120 Lille France 59037
    121 Lyon France 69288
    122 Rouen France 76031
    123 Strasbourg France 67091
    124 Berlin Germany 13353
    125 Bonn Germany 531105
    126 Düsseldorf Germany 40225
    127 Frankfurt Am Main Germany 60590
    128 Freiburg Germany 79106
    129 Giessen Germany 35392
    130 Hamburg Germany 20246
    131 Hannover Germany 30625
    132 Heidelberg Germany 69120
    133 Kiel Germany 24105
    134 Köln Germany 50924
    135 Tübingen Germany 72076
    136 Bekescsaba Hungary 5600
    137 Budapest Hungary 1083
    138 Budapest Hungary 1097
    139 Debrecen Hungary 4032
    140 Gyor Hungary 9024
    141 Gyula Hungary 5700
    142 Pecs Hungary 7654
    143 Szombathely Hungary 9700
    144 Amsterdam Netherlands 1091 AC
    145 Leiden Netherlands 2333 ZA
    146 Rotterdam Netherlands 3015 GD
    147 Bydgoszcz Poland 85-030
    148 Chorzow Poland 41-500
    149 Kielce Poland 25-317
    150 Lodz Poland 91-347
    151 Warszawa Poland 01-201
    152 Wroclaw Poland 51-124
    153 Ponce Puerto Rico 00716
    154 San Juan Puerto Rico 00936-5067
    155 Santurce Puerto Rico 00909
    156 Bucharest Romania 010825
    157 Bucharest Romania 021105
    158 Bucharest Romania 022328
    159 Bucharest Romania 030303
    160 Cluj-napoca Romania
    161 Constanta Romania
    162 Iasi Romania 700111
    163 Timisoara Romania
    164 Jaloslave Russian Federation
    165 Moscow Russian Federation 105229
    166 Moscow Russian Federation 11/5
    167 Moscow Russian Federation 115446
    168 Moscow Russian Federation 117333
    169 Moscow Russian Federation 119881
    170 Moscow Russian Federation 127009
    171 Moscow Russian Federation 143420
    172 Nizhny Novgorod Russian Federation 603022
    173 Samara Russian Federation 443011
    174 Smolensk Russian Federation 214006
    175 St Petersburg Russian Federation 194044
    176 Stavropol Russian Federation 355017
    177 Stockholm Sweden
    178 Uppsala Sweden 75185
    179 London United Kingdom SE5 9RS
    180 London United Kingdom SW10 9TH
    181 London United Kingdom SW17 0QT
    182 Newcastle Upon Tyne United Kingdom NE7 7DN
    183 Plymouth United Kingdom PL6 8DH
    184 Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00394277
    Other Study ID Numbers:
    • NV18210
    First Posted:
    Oct 31, 2006
    Last Update Posted:
    Aug 3, 2010
    Last Verified:
    Jul 1, 2010
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Ribavirin
    Peginterferon alfa-2a
    Interferon-alpha

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Arm/Group Description PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
    Period Title: Overall Study
    STARTED 195 196 393 391
    COMPLETED 137 136 273 266
    NOT COMPLETED 58 60 120 125

    Baseline Characteristics

    Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg Total
    Arm/Group Description PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. Total of all reporting groups
    Overall Participants 195 196 393 391 1175
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    46.1
    (9.86)
    45.1
    (9.50)
    45.7
    (9.64)
    46.0
    (10.18)
    45.7
    (9.83)
    Gender (Patients) [Number]
    Female
    37
    41
    90
    73
    241
    Male
    154
    148
    292
    310
    904

    Outcome Measures

    1. Primary Outcome
    Title Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
    Description SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).
    Time Frame Week 72

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population (all patients treated with at least one dose of either study medication)
    Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Arm/Group Description PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
    Measure Participants 191 189 382 383
    Number [Percentage of patients]
    37.7
    42.9
    43.5
    40.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PEG-IFN 180 µg + Ribavirin 1200 mg, PEG-IFN 180 µg + Ribavirin 1400/1600 mg, PEG-IFN 360/180 µg + Ribavirin 1200 mg, PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Comments This reflects the primary protocol-specified comparison (standard Pegasys induction dosing arms versus pooled Pegasys induction dosing arms). The study was designed to have at least 86% power for testing the null hypothesis of no difference between these two pooled groups, with assumed response rates of 28%, 32%, 36%, and 43% in the four treatment arms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.584
    Comments All secondary comparisons were tested at a two-sided significance level of 0.05.
    Method Cochran-Mantel-Haenszel
    Comments P-value obtained from CMH test, stratified by country and ribavirin dose strata.
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.075
    Confidence Interval () 95%
    0.831 to 1.391
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title SVR-24 (Actual Treatment Period)
    Description SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.
    Time Frame 24 weeks after end of treatment

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population (all patients treated with at least one dose of either study medication)
    Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Arm/Group Description PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
    Measure Participants 191 189 382 383
    Number [Percentage of patients]
    38.2
    43.9
    43.5
    40.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PEG-IFN 180 µg + Ribavirin 1200 mg, PEG-IFN 180 µg + Ribavirin 1400/1600 mg, PEG-IFN 360/180 µg + Ribavirin 1200 mg, PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Comments (PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.775
    Comments All secondary comparisons are tested at a two-sided significance level of 0.05.
    Method Cochran-Mantel-Haenszel
    Comments P-value obtained from CMH test, stratified by country and ribavirin dose strata.
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.039
    Confidence Interval () 95%
    0.803 to 1.344
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title SVR-12 (Scheduled Treatment Period)
    Description SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60).
    Time Frame 12 weeks after end of treatment

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population (all patients treated with at least one dose of either study medication)
    Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Arm/Group Description PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
    Measure Participants 191 189 382 383
    Number [Percentage of patients]
    40.3
    45.0
    44.2
    41.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PEG-IFN 180 µg + Ribavirin 1200 mg, PEG-IFN 180 µg + Ribavirin 1400/1600 mg, PEG-IFN 360/180 µg + Ribavirin 1200 mg, PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Comments (PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.973
    Comments All secondary comparisons are tested at a two-sided significance level of 0.05.
    Method Cochran-Mantel-Haenszel
    Comments P-value obtained from CMH test, stratified by country and ribavirin dose strata.
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.004
    Confidence Interval () 95%
    0.777 to 1.299
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title SVR-12 (Actual Treatment Period)
    Description SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.
    Time Frame 12 weeks after end of treatment

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population (all patients treated with at least one dose of either study medication)
    Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Arm/Group Description PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
    Measure Participants 191 189 382 383
    Number [Percentage of patients]
    40.3
    45.5
    44.2
    42.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PEG-IFN 180 µg + Ribavirin 1200 mg, PEG-IFN 180 µg + Ribavirin 1400/1600 mg, PEG-IFN 360/180 µg + Ribavirin 1200 mg, PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Comments (PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.951
    Comments All secondary comparisons are tested at a two-sided significance level of 0.05.
    Method Cochran-Mantel-Haenszel
    Comments P-value obtained from CMH test, stratified by country and ribavirin dose strata.
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.008
    Confidence Interval () 95%
    0.780 to 1.304
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Arm/Group Description PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
    All Cause Mortality
    PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 22/191 (11.5%) 20/189 (10.6%) 36/382 (9.4%) 39/383 (10.2%)
    Blood and lymphatic system disorders
    Anaemia 0/191 (0%) 2/189 (1.1%) 2/382 (0.5%) 3/383 (0.8%)
    Thrombocytopenia 2/191 (1%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Anaemia Haemolytic Autoimmune 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Pancytopenia 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Cardiac disorders
    Angina Pectoris 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 2/383 (0.5%)
    Acute Coronary Syndrome 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Arrhythmia 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Atrial Fibrillation 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Cardiac Arrest 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Cardiac Failure Congestive 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Myocardial Infarction 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Endocrine disorders
    Hyperthyroidism 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Eye disorders
    Retinal Haemorrhage 1/191 (0.5%) 1/189 (0.5%) 1/382 (0.3%) 0/383 (0%)
    Retinal Detachment 0/191 (0%) 1/189 (0.5%) 1/382 (0.3%) 0/383 (0%)
    Glaucoma 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Gastrointestinal disorders
    Abdominal Pain 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 2/383 (0.5%)
    Intestinal Obstruction 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Pancreatitis Acute 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Small Intestinal Obstruction 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Vomiting 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    General disorders
    Non-Cardiac Chest Pain 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Asthenia 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Fatigue 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Gait Disturbance 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Hyperplasia 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Malaise 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Multi-Organ Failure 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Pain 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Hepatobiliary disorders
    Cholelithiasis 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 1/383 (0.3%)
    Hepatic Failure 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 1/383 (0.3%)
    Cholecystitis 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Cholecystitis Acute 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Hepatorenal Syndrome 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Infections and infestations
    Pneumonia 1/191 (0.5%) 3/189 (1.6%) 2/382 (0.5%) 4/383 (1%)
    Appendicitis 0/191 (0%) 0/189 (0%) 3/382 (0.8%) 2/383 (0.5%)
    Cellulitis 1/191 (0.5%) 0/189 (0%) 2/382 (0.5%) 0/383 (0%)
    Abscess Limb 1/191 (0.5%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Gastroenteritis 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 1/383 (0.3%)
    Pyelonephritis 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 1/383 (0.3%)
    Pyelonephritis Acute 0/191 (0%) 2/189 (1.1%) 0/382 (0%) 0/383 (0%)
    Anal Abscess 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Bronchitis 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Bursitis Infective 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Gastroenteritis Viral 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Injection Site Abscess 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Intervertebral Discitis 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Lobar Pneumonia 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Lung Abscess 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Lung Infection 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Osteomyelitis 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Pelvic Abscess 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Pelvic Inflammatory Disease 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Rectal Abscess 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Sepsis 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Subcutaneous Abscess 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Injury, poisoning and procedural complications
    Overdose 0/191 (0%) 1/189 (0.5%) 1/382 (0.3%) 0/383 (0%)
    Ankle Fracture 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Meniscus Lesion 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Multiple Fractures 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Postoperative Fever 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Radius Fracture 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Venom Poisoning 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Metabolism and nutrition disorders
    Dehydration 0/191 (0%) 0/189 (0%) 2/382 (0.5%) 1/383 (0.3%)
    Diabetic Ketoacidosis 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Musculoskeletal and connective tissue disorders
    Back Pain 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Fracture Nonunion 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Intervertebral Disc Protrusion 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Musculoskeletal Chest Pain 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Hepatic Neoplasm Malignant 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Pancreatic Carcinoma 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Pancreatic Neoplasm 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Tonsil Cancer 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Nervous system disorders
    Cerebral Haemorrhage 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 1/383 (0.3%)
    Altered State of Consciousness 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Cerebrovascular Accident 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Headache 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Hepatic Encephalopathy 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Metabolic Encephalopathy 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Peripheral Motor Neuropathy 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Syncope 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Transient Ischaemic Attack 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Psychiatric disorders
    Depression 0/191 (0%) 3/189 (1.6%) 1/382 (0.3%) 0/383 (0%)
    Suicidal Ideation 0/191 (0%) 0/189 (0%) 2/382 (0.5%) 0/383 (0%)
    Acute Psychosis 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Alcoholism 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Bipolar Disorder 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Completed Suicide 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Dependence 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Hostility 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Major Depression 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Panic Attack 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 0/383 (0%)
    Psychotic Disorder 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Suicide Attempt 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Renal and urinary disorders
    Calculus Ureteric 0/191 (0%) 0/189 (0%) 2/382 (0.5%) 0/383 (0%)
    Renal Failure Acute 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Tubulointerstitial Nephritis 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Respiratory, thoracic and mediastinal disorders
    Alveolitis Fibrosing 1/191 (0.5%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Haemoptysis 0/191 (0%) 0/189 (0%) 0/382 (0%) 2/383 (0.5%)
    Pneumothorax 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Skin and subcutaneous tissue disorders
    Dermatitis 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Psoriasis 0/191 (0%) 0/189 (0%) 1/382 (0.3%) 0/383 (0%)
    Skin Ulcer 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Vascular disorders
    Hypertension 0/191 (0%) 0/189 (0%) 0/382 (0%) 1/383 (0.3%)
    Vena Cava Thrombosis 0/191 (0%) 1/189 (0.5%) 0/382 (0%) 0/383 (0%)
    Other (Not Including Serious) Adverse Events
    PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 186/191 (97.4%) 179/189 (94.7%) 370/382 (96.9%) 373/383 (97.4%)
    Blood and lymphatic system disorders
    Anaemia 23/191 (12%) 22/189 (11.6%) 38/382 (9.9%) 54/383 (14.1%)
    Neutropenia 9/191 (4.7%) 16/189 (8.5%) 29/382 (7.6%) 28/383 (7.3%)
    Gastrointestinal disorders
    Nausea 41/191 (21.5%) 42/189 (22.2%) 112/382 (29.3%) 104/383 (27.2%)
    Diarrhoea 25/191 (13.1%) 27/189 (14.3%) 62/382 (16.2%) 62/383 (16.2%)
    Vomiting 12/191 (6.3%) 19/189 (10.1%) 42/382 (11%) 31/383 (8.1%)
    Abdominal Pain Upper 11/191 (5.8%) 18/189 (9.5%) 28/382 (7.3%) 23/383 (6%)
    Dyspepsia 9/191 (4.7%) 12/189 (6.3%) 25/382 (6.5%) 23/383 (6%)
    Dry Mouth 5/191 (2.6%) 14/189 (7.4%) 23/382 (6%) 23/383 (6%)
    Abdominal Pain 6/191 (3.1%) 10/189 (5.3%) 15/382 (3.9%) 13/383 (3.4%)
    Constipation 5/191 (2.6%) 13/189 (6.9%) 9/382 (2.4%) 14/383 (3.7%)
    General disorders
    Pyrexia 83/191 (43.5%) 78/189 (41.3%) 176/382 (46.1%) 205/383 (53.5%)
    Fatigue 66/191 (34.6%) 102/189 (54%) 184/382 (48.2%) 182/383 (47.5%)
    Chills 42/191 (22%) 55/189 (29.1%) 122/382 (31.9%) 132/383 (34.5%)
    Asthenia 28/191 (14.7%) 35/189 (18.5%) 84/382 (22%) 80/383 (20.9%)
    Irritability 34/191 (17.8%) 29/189 (15.3%) 64/382 (16.8%) 66/383 (17.2%)
    Pain 10/191 (5.2%) 18/189 (9.5%) 24/382 (6.3%) 31/383 (8.1%)
    Injection Site Erythema 16/191 (8.4%) 14/189 (7.4%) 28/382 (7.3%) 24/383 (6.3%)
    Injection Site Reaction 12/191 (6.3%) 13/189 (6.9%) 20/382 (5.2%) 14/383 (3.7%)
    Malaise 10/191 (5.2%) 10/189 (5.3%) 14/382 (3.7%) 18/383 (4.7%)
    Infections and infestations
    Upper Respiratory Tract Infection 11/191 (5.8%) 7/189 (3.7%) 11/382 (2.9%) 16/383 (4.2%)
    Investigations
    Weight Decreased 31/191 (16.2%) 31/189 (16.4%) 54/382 (14.1%) 67/383 (17.5%)
    Metabolism and nutrition disorders
    Decreased Appetite 30/191 (15.7%) 31/189 (16.4%) 73/382 (19.1%) 85/383 (22.2%)
    Musculoskeletal and connective tissue disorders
    Myalgia 46/191 (24.1%) 44/189 (23.3%) 111/382 (29.1%) 118/383 (30.8%)
    Arthralgia 50/191 (26.2%) 49/189 (25.9%) 88/382 (23%) 89/383 (23.2%)
    Back Pain 21/191 (11%) 22/189 (11.6%) 28/382 (7.3%) 23/383 (6%)
    Muscle Spasms 8/191 (4.2%) 12/189 (6.3%) 13/382 (3.4%) 15/383 (3.9%)
    Nervous system disorders
    Headache 75/191 (39.3%) 76/189 (40.2%) 151/382 (39.5%) 168/383 (43.9%)
    Dizziness 14/191 (7.3%) 27/189 (14.3%) 44/382 (11.5%) 59/383 (15.4%)
    Disturbance in Attention 5/191 (2.6%) 6/189 (3.2%) 20/382 (5.2%) 27/383 (7%)
    Psychiatric disorders
    Insomnia 46/191 (24.1%) 45/189 (23.8%) 98/382 (25.7%) 113/383 (29.5%)
    Depression 31/191 (16.2%) 33/189 (17.5%) 65/382 (17%) 56/383 (14.6%)
    Anxiety 11/191 (5.8%) 18/189 (9.5%) 31/382 (8.1%) 23/383 (6%)
    Respiratory, thoracic and mediastinal disorders
    Cough 27/191 (14.1%) 35/189 (18.5%) 59/382 (15.4%) 69/383 (18%)
    Dyspnoea 15/191 (7.9%) 15/189 (7.9%) 39/382 (10.2%) 32/383 (8.4%)
    Oropharyngeal Pain 12/191 (6.3%) 11/189 (5.8%) 16/382 (4.2%) 22/383 (5.7%)
    Dyspnoea Exertional 6/191 (3.1%) 13/189 (6.9%) 17/382 (4.5%) 16/383 (4.2%)
    Epistaxis 10/191 (5.2%) 10/189 (5.3%) 9/382 (2.4%) 14/383 (3.7%)
    Skin and subcutaneous tissue disorders
    Rash 38/191 (19.9%) 40/189 (21.2%) 65/382 (17%) 78/383 (20.4%)
    Pruritus 34/191 (17.8%) 27/189 (14.3%) 76/382 (19.9%) 59/383 (15.4%)
    Alopecia 23/191 (12%) 20/189 (10.6%) 71/382 (18.6%) 71/383 (18.5%)
    Dry Skin 23/191 (12%) 22/189 (11.6%) 38/382 (9.9%) 37/383 (9.7%)
    Vascular disorders
    Hypertension 7/191 (3.7%) 11/189 (5.8%) 16/382 (4.2%) 20/383 (5.2%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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

    Name/Title Medical Communications
    Organization Hoffmann-La Roche
    Phone 800-821-8590
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00394277
    Other Study ID Numbers:
    • NV18210
    First Posted:
    Oct 31, 2006
    Last Update Posted:
    Aug 3, 2010
    Last Verified:
    Jul 1, 2010