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Trial record 10 of 26 for:    "Hepatitis" | "Guaifenesin"

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.

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ClinicalTrials.gov Identifier: NCT00087594
Recruitment Status : Completed
First Posted : July 14, 2004
Results First Posted : March 4, 2016
Last Update Posted : March 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: peginterferon alfa-2a [Pegasys]
Drug: ribavirin
Enrollment 48
Recruitment Details A total of 48 participants were screened at 6 study sites in the United States (U.S) between 20 November 2003 and 25 September 2006.
Pre-assignment Details  
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1. Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Period Title: Overall Study
Started 24 24
Completed 16 12
Not Completed 8 12
Reason Not Completed
Adverse Event             2             3
Lost to Follow-up             0             2
Withdrawal by Subject             4             2
Lack of Efficacy             2             5
Arm/Group Title Direct Observed Therapy Self-Administration Therapy Total
Hide Arm/Group Description Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1. Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1. Total of all reporting groups
Overall Number of Baseline Participants 24 24 48
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Population included all enrolled participants who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 48 participants
47.9  (10.50) 46.8  (9.45) 47.4  (9.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Female
4
  16.7%
8
  33.3%
12
  25.0%
Male
20
  83.3%
16
  66.7%
36
  75.0%
1.Primary Outcome
Title Number of Participants With Treatment Completion Rate (TCR)
Hide Description TCR is defined as the number of participants who completed the prescribed duration of the study treatment. TCR for G1 participants is defined as the number of participants who had a missing value or >= 2-log10 decrease in Hepatitis C virus-ribonucleic acid (HCV RNA) at Week 12 and completed 48 weeks of study treatment or had a < 2-log10 decrease from baseline at Week 12 and completed at least 12 weeks of study treatment. TCR for G2/ 3 participants is defined as the number of participants who completed 24 weeks of study treatment.
Time Frame Up to 24 weeks for G2/3; up to 48 weeks for G1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
G1 (n = 13, 16) 9 10
G1, 2 log drop at Week 12 (n = 4, 9) 4 5
G1, non 2 log drop at Week 12 (n = 4, 4) 4 4
G1, missing HCV-RNA at Week 12 (n = 5, 3) 1 1
G2/3 (n = 11, 8) 11 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Direct Observed Therapy, Self-Administration Therapy
Comments 95% CI for G1 participants
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 7
Confidence Interval (2-Sided) 95%
-27.8 to 41.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Direct Observed Therapy, Self-Administration Therapy
Comments 95% CI for G2/3 participants
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 13
Confidence Interval (2-Sided) 95%
-10.4 to 35.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Direct Observed Therapy, Self-Administration Therapy
Comments 95% CI for G1 participants with 2 log drop at W 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 44
Confidence Interval (2-Sided) 95%
12.0 to 76.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Direct Observed Therapy, Self-Administration Therapy
Comments 95% CI for G1 participants with non 2 log drop at W 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Direct Observed Therapy, Self-Administration Therapy
Comments 95% CI for G1 participants with missing HCV-RNA at W 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -13
Confidence Interval (2-Sided) 95%
-77.2 to 50.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1)
Hide Description SVR is defined as the number of participants with undetectable HCV-RNA (< 10 international unit per milliliter [IU/mL]) at 24 weeks post treatment completion.
Time Frame Week 48 for G2/3 and Week 72 for G1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
G1 (n = 13, 16) 4 5
G2/3 (n = 11, 8) 10 2
3.Secondary Outcome
Title Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion
Hide Description Virological Response Rate is defined as the number of participants with undetectable HCV-RNA (< 10 IU/mL). Treatment completion (end of treatment [EOT]) for G1 was Week 48 and for G2 or 3 was Week 24.
Time Frame Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
Week 12 (G1), (n = 13, 16) 3 5
Week 24 (G1), (n = 13, 16) 5 8
Week 48 (EOT) (G1), (n = 13, 16) 5 8
12 weeks after EOT (G1), (n = 13, 16) 5 4
Week 12 (G2/3), (n = 11, 8) 11 8
Week 24 (EOT) (G2/3), (n = 11, 8) 11 7
12 Weeks after EOT (G2/3), (n = 11, 8) 9 3
4.Secondary Outcome
Title Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion
Hide Description Biochemical response is defined as the number of participants with a normal serum alanine aminotransferase (ALT) concentration (i.e., ALT < 30 U/L). EOT for G1 was Week 48 and for G2/3 was Week 24.
Time Frame Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
Week 12 (G1), (n = 13, 16) 3 13
Week 24 (G1), (n = 13, 16) 5 13
Week 48/EOT (G1), (n = 13, 16) 4 5
12 Weeks after EOT (G1), (n = 13, 16) 6 8
24 Weeks after EOT (G1), (n = 13, 16) 4 7
Week 12 (G2/3), (n = 11, 8) 10 2
Week 24/EOT (G2/3), (n = 11, 8) 10 4
12 Weeks after EOT (G2/3), (n = 11, 8) 10 4
24 Weeks after EOT (G2/3), (n = 11, 8) 11 3
5.Secondary Outcome
Title Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
Week 12 (G1), (n = 13, 16) 4 9
Week 12 (G2/3), (n = 11, 8) 11 8
6.Secondary Outcome
Title Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II)
Hide Description BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).
Time Frame Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline, (n = 24, 24) 8.7  (1.2) 8.6  (0.9)
EOT (Week 24/48), (n = 18, 13) 13.6  (2.4) 22.8  (3.0)
EOS (Week 48/72), (n = 22, 19) 8.6  (2.0) 13.4  (2.4)
7.Secondary Outcome
Title Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits
Hide Description BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).
Time Frame Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Mean (Standard Error)
Unit of Measure: units on a scale
EOT (Week 24/48), (n = 18, 13) 6.1  (2.2) 13.5  (3.2)
EOS (Week 48/72), (n = 22, 19) 0.4  (1.8) 4.5  (2.4)
8.Secondary Outcome
Title Number of Participants With Degrees of Depression as Defined by the BDI-II Score
Hide Description Participants with degrees of depression as defined by the BDI-II Score were reported. BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
Baseline, none-mild 22 24
Baseline, moderate 2 0
Highest post-baseline, none-mild 16 9
Highest post-baseline, moderate 5 11
Highest post-baseline, severe 3 3
Last post-baseline, none-mild 20 18
Last post-baseline, moderate 3 3
Last post-baseline, severe 1 2
9.Secondary Outcome
Title Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit
Hide Description The HQLQ is a multiple-choice questionnaire includes the eight individual qualify-of-life scales of the Medical Outcomes Study 36-item Short-form Health Survey as: Social functioning (SF), role limitations due to emotional problems (RE), vitality (VT), general mental health (MH), physical functioning (PF), role limitations due to physical problems (RP), freedom from bodily pain (BP), and general health (GH). In addition, two other generic scales (positive well-being [PWB] and health distress [HD]) and two hepatitis-specific scales (limitations because of chronic hepatitis C [HLIM] and health distress because of chronic hepatitis C [HHD]) were included. Scores were scaled to a 0 to 100 range, with 0 = bad and 100 = good. A higher score indicates an improvement.
Time Frame Baseline (Day -30 to -1), 24 weeks after EOT visit (Week 48 for G2/3 and Week 72 for G1)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Mean (Standard Error)
Unit of Measure: units on a scale
SF at Baseline (n = 23, 24) 70.7  (4.1) 75.5  (5.2)
SF at EOT, (n = 15, 12) 50.0  (7.0) 35.4  (8.9)
SF at 24 Weeks after EOT, (n = 17, 15) 72.8  (6.8) 59.2  (8.4)
RE at Baseline (n = 23, 24) 55.1  (9.0) 75.0  (7.0)
RE at EOT, (n = 14, 12) 47.6  (12.0) 36.1  (12.6)
RE at 24 Weeks after EOT, (n = 17, 15) 74.5  (9.7) 62.2  (11.7)
MH at Baseline (n = 23, 24) 63.7  (3.4) 73.5  (3.6)
MH at EOT, (n = 15, 12) 53.6  (5.9) 51.7  (5.6)
MH at 24 Weeks after EOT, (n = 17, 15) 67.5  (6.1) 57.9  (4.7)
PF at Baseline (n = 23, 24) 74.6  (4.9) 80.0  (4.6)
PF at EOT, (n = 15, 12) 59.0  (8.4) 52.9  (8.3)
PF at 24 Weeks after EOT, (n = 17, 14) 75.9  (6.0) 62.9  (8.8)
RP at Baseline (n = 23, 24) 62.0  (8.1) 59.4  (8.8)
RP at EOT, (n = 15, 12) 26.7  (9.6) 16.7  (7.1)
RP at 24 Weeks after EOT, (n = 17, 14) 66.2  (9.3) 55.4  (11.5)
BP at Baseline (n = 23, 24) 67.0  (4.6) 72.2  (4.1)
BP at EOT, (n = 14, 12) 55.9  (5.6) 47.8  (6.9)
BP at 24 Weeks after EOT, (n = 17, 15) 66.7  (6.0) 68.1  (7.3)
GH at Baseline (n = 23, 24) 56.3  (2.8) 60.8  (4.0)
GH at EOT, (n = 15, 12) 54.0  (5.3) 37.2  (4.4)
GH at 24 Weeks after EOT, (n = 17, 15) 58.7  (6.5) 46.6  (5.4)
VT at Baseline (n = 23, 24) 48.0  (4.2) 52.7  (3.8)
VT at EOT, (n = 15, 12) 29.0  (4.6) 20.0  (4.8)
VT at 24 Weeks after EOT, (n = 17, 15) 54.4  (6.9) 41.3  (5.9)
HD at Baseline (n = 23, 24) 65.7  (4.9) 76.9  (4.5)
HD at EOT, (n = 15, 12) 62.3  (5.7) 43.3  (7.8)
HD at 24 Weeks after EOT, (n = 17, 15) 73.8  (6.8) 52.7  (7.3)
PWB at Baseline (n = 23, 24) 50.0  (4.4) 40.2  (4.3)
PWB at EOT, (n = 15, 12) 65.3  (5.5) 63.8  (5.6)
PWB at 24 Weeks after EOT, (n = 17, 15) 45.3  (6.7) 47.0  (6.6)
HLIM at Baseline (n = 23, 23) 74.5  (6.0) 76.8  (6.1)
HLIM at EOT, (n = 15, 12) 59.1  (7.4) 40.0  (8.7)
HLIM at 24 Weeks after EOT, (n = 16, 15) 84.2  (5.6) 68.9  (9.6)
HHD at Baseline (n = 23, 23) 62.8  (5.5) 69.8  (5.7)
HHD at EOT, (n = 15, 12) 58.7  (8.2) 50.4  (7.4)
HHD at 24 Weeks after EOT, (n = 16, 15) 81.6  (6.0) 67.3  (7.3)
10.Secondary Outcome
Title Number of Participants With Compliance to the Prescribed Treatment Regimen
Hide Description Participants with compliance to the prescribed treatment regimen for peginterferon alfa-2a and ribavirin was reported. Compliance was calculated as (total cumulative dose taken) / (total cumulative original dose prescribed for the entire study) x 100. Total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (48*7) for G1, total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (24*7) for G2/3.
Time Frame Up to Week 24 for G 2/3; up to Week 48 for G1
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Hide Analysis Population Description
Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
Peginterferon alfa-2a, 0-60% 8 8
Peginterferon alfa-2a, >60-80% 0 1
Peginterferon alfa-2a, >80-97% 1 4
Peginterferon alfa-2a, >97% 15 11
Ribavirin, 0-60% 8 10
Ribavirin, >60-80% 4 1
Ribavirin, >80-97% 5 7
Ribavirin, >97% 7 6
Total Treatment Duration, 0-60% 8 8
Total Treatment Duration, >60-80% 0 1
Total Treatment Duration, >80-97% 1 3
Total Treatment Duration, >97% 15 12
11.Secondary Outcome
Title Number of Participants With Abnormal Vital Signs
Hide Description Vital Signs included systolic blood pressures (SBP), diastolic blood pressures (DBP), and pulse rate (PR). Abnormal vital signs were reported as low or high abnormal. It was defined as < 85 mm Hg or > 180 mm Hg with a change from baseline of > 20%; DBP as > 110 mm Hg with a change from baseline of > 20%; and PR as < 50 bpm and > 120 bpm with a change from baseline of > 20%.
Time Frame Up to 24 weeks of treatment-free follow-up visit (Week 48 for G2/3 and Week 72 for G1)
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Hide Analysis Population Description
Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
SBP - High 1 0
SBP - Low 1 0
DBP - High 2 0
PR - Low 1 1
12.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities (Hematology)
Hide Description Hematology included hematocrit (fraction), hemoglobin, platelets count, Red blood cells (RBC), White blood cell (WBC), eosinophils, lymphocytes, monocytes, neutrophils, Partial Thromboplastin time (PTT), Prothrombin Time International Normalized Ratio (PT INR). Laboratory values falling outside the marked reference range as defined by Roche's "International Guideline for the Handling and Reporting of Laboratory Data”, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal.
Time Frame Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)
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Hide Analysis Population Description
Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
Hematocrit (fraction) – Low (n = 24, 24) 10 11
Hemoglobin - Low (n = 24, 24) 10 16
Platelets - Low (n = 24, 24) 11 10
RBC - Low (n = 24, 24) 14 18
WBC - High (n = 24, 24) 0 1
WBC - Low (n = 24, 24) 18 19
Eosinophils - High (n = 24, 24) 0 1
Lymphocytes - Low (n = 24, 24) 8 10
Monocytes - High (n = 24, 24) 0 1
Neutrophils - High (n = 24, 24) 0 4
Neutrophils - Low (n = 24, 24) 19 20
PTT - High (n = 22, 23) 2 3
PT INR (ratio) - High (n = 22, 23) 0 2
13.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities (Biochemistry)
Hide Description Laboratory values falling outside the marked reference range as defined by Roche's "International Guideline for the Handling and Reporting of Laboratory Data”, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal.
Time Frame Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
Aspartate aminotransferase – High (n = 24, 24) 2 8
Alanine aminotransferase – High (n = 24, 24) 2 4
Albumin – Low (n = 24, 24) 0 4
Total protein – High (n = 24, 24) 1 1
Total protein – Low (n = 24, 24) 0 1
Chloride – Low (n = 24, 24) 2 3
Sodium – Low (n = 24, 24) 3 2
Calcium – Low (n = 24, 24) 0 5
Phosphate - High (n = 24, 24) 1 2
Phosphate - Low (n = 24, 24) 6 7
Glucose random – High (n = 24, 24) 1 2
Triglycerides – High (n = 24, 24) 9 6
Thyroxine (T4) – High (n = 22, 22) 4 2
Thyroid-Stimulating Hormone – High (n = 22, 22) 0 3
14.Secondary Outcome
Title Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Reason for discontinuation was categorized as safety and non-safety, where safety reasons included abnormality of laboratory tests, AEs, and death; and non-safety reasons included insufficient therapeutic response, early improvement, violation of selection criteria at entry, other protocol violation, refused treatment, failure to return and other. Participants who discontinued the study with any reason were recorded.
Time Frame Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description:
Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
Any AEs 24 24
Any SAEs 3 3
AEs 2 3
Study discontinuation due to Insufficient Response 2 5
Study discontinuation due to Refused Treatment 4 2
Study discontinuation due to Failure to Return 0 2
Time Frame From baseline to Week 72
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Direct Observed Therapy Self-Administration Therapy
Hide Arm/Group Description Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1. Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
All-Cause Mortality
Direct Observed Therapy Self-Administration Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Direct Observed Therapy Self-Administration Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   3/24 (12.50%)   3/24 (12.50%) 
Gastrointestinal disorders     
Abdominal pain  1  0/24 (0.00%)  1/24 (4.17%) 
General disorders     
Drug withdrawal syndrome  1  0/24 (0.00%)  1/24 (4.17%) 
Hepatobiliary disorders     
Bile duct stone  1  0/24 (0.00%)  1/24 (4.17%) 
Infections and infestations     
Cellulitis  1  0/24 (0.00%)  1/24 (4.17%) 
Injury, poisoning and procedural complications     
Heat stroke  1  0/24 (0.00%)  1/24 (4.17%) 
Overdose  1  0/24 (0.00%)  1/24 (4.17%) 
Psychiatric disorders     
Psychotic disorder  1  1/24 (4.17%)  0/24 (0.00%) 
Suicidal ideation  1  1/24 (4.17%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/24 (4.17%)  0/24 (0.00%) 
Pneumonia aspiration  1  0/24 (0.00%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Direct Observed Therapy Self-Administration Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   24/24 (100.00%)   24/24 (100.00%) 
Blood and lymphatic system disorders     
Neutropenia  1  8/24 (33.33%)  8/24 (33.33%) 
Anaemia  1  4/24 (16.67%)  3/24 (12.50%) 
Thrombocytopenia  1  4/24 (16.67%)  1/24 (4.17%) 
Eye disorders     
Vision blurred  1  0/24 (0.00%)  2/24 (8.33%) 
Gastrointestinal disorders     
Nausea  1  13/24 (54.17%)  14/24 (58.33%) 
Vomiting  1  6/24 (25.00%)  9/24 (37.50%) 
Dry mouth  1  3/24 (12.50%)  5/24 (20.83%) 
Abdominal pain upper  1  3/24 (12.50%)  3/24 (12.50%) 
Constipation  1  3/24 (12.50%)  2/24 (8.33%) 
Abdominal pain  1  2/24 (8.33%)  3/24 (12.50%) 
Diarrhoea  1  2/24 (8.33%)  1/24 (4.17%) 
Stomatitis  1  2/24 (8.33%)  0/24 (0.00%) 
Toothache  1  2/24 (8.33%)  0/24 (0.00%) 
Gastritis  1  0/24 (0.00%)  2/24 (8.33%) 
General disorders     
Fatigue  1  16/24 (66.67%)  19/24 (79.17%) 
Irritability  1  8/24 (33.33%)  9/24 (37.50%) 
Chills  1  6/24 (25.00%)  7/24 (29.17%) 
Pyrexia  1  5/24 (20.83%)  8/24 (33.33%) 
Injection site erythema  1  4/24 (16.67%)  2/24 (8.33%) 
Asthenia  1  3/24 (12.50%)  2/24 (8.33%) 
Influenza like illness  1  1/24 (4.17%)  3/24 (12.50%) 
Infections and infestations     
Upper respiratory tract infection  1  3/24 (12.50%)  1/24 (4.17%) 
Bronchitis  1  2/24 (8.33%)  2/24 (8.33%) 
Urinary tract infection  1  1/24 (4.17%)  3/24 (12.50%) 
Nasopharyngitis  1  1/24 (4.17%)  2/24 (8.33%) 
Rhinitis  1  2/24 (8.33%)  0/24 (0.00%) 
Cellulitis  1  1/24 (4.17%)  2/24 (8.33%) 
Injury, poisoning and procedural complications     
Excoriation  1  2/24 (8.33%)  1/24 (4.17%) 
Joint sprain  1  0/24 (0.00%)  2/24 (8.33%) 
Investigations     
Blood pressure increased  1  2/24 (8.33%)  0/24 (0.00%) 
Drug screen positive  1  7/24 (29.17%)  4/24 (16.67%) 
Haemoglobin decreased  1  2/24 (8.33%)  2/24 (8.33%) 
Metabolism and nutrition disorders     
Decreased appetite  1  5/24 (20.83%)  10/24 (41.67%) 
Hypokalaemia  1  0/24 (0.00%)  2/24 (8.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  9/24 (37.50%)  9/24 (37.50%) 
Myalgia  1  4/24 (16.67%)  8/24 (33.33%) 
Pain in extremity  1  3/24 (12.50%)  1/24 (4.17%) 
Back pain  1  3/24 (12.50%)  0/24 (0.00%) 
Nervous system disorders     
Headache  1  9/24 (37.50%)  10/24 (41.67%) 
Dysgeusia  1  3/24 (12.50%)  3/24 (12.50%) 
Dizziness  1  3/24 (12.50%)  1/24 (4.17%) 
Hypoaesthesia  1  2/24 (8.33%)  1/24 (4.17%) 
Lethargy  1  1/24 (4.17%)  2/24 (8.33%) 
Mental impairment  1  2/24 (8.33%)  0/24 (0.00%) 
Paraesthesia  1  0/24 (0.00%)  2/24 (8.33%) 
Psychiatric disorders     
Depression  1  9/24 (37.50%)  10/24 (41.67%) 
Insomnia  1  8/24 (33.33%)  10/24 (41.67%) 
Anxiety  1  3/24 (12.50%)  1/24 (4.17%) 
Confusional state  1  2/24 (8.33%)  1/24 (4.17%) 
Agitation  1  2/24 (8.33%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/24 (12.50%)  4/24 (16.67%) 
Dyspnoea  1  3/24 (12.50%)  3/24 (12.50%) 
Pharyngolaryngeal pain  1  0/24 (0.00%)  4/24 (16.67%) 
Epistaxis  1  1/24 (4.17%)  2/24 (8.33%) 
Nasal congestion  1  2/24 (8.33%)  0/24 (0.00%) 
Rhinorrhoea  1  0/24 (0.00%)  2/24 (8.33%) 
Skin and subcutaneous tissue disorders     
Rash  1  12/24 (50.00%)  6/24 (25.00%) 
Dry skin  1  5/24 (20.83%)  4/24 (16.67%) 
Alopecia  1  3/24 (12.50%)  6/24 (25.00%) 
Rash papular  1  2/24 (8.33%)  2/24 (8.33%) 
Hyperhidrosis  1  0/24 (0.00%)  3/24 (12.50%) 
Surgical and medical procedures     
Tooth extraction  1  0/24 (0.00%)  2/24 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 61 6878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00087594     History of Changes
Other Study ID Numbers: ML17251
First Submitted: July 12, 2004
First Posted: July 14, 2004
Results First Submitted: December 3, 2015
Results First Posted: March 4, 2016
Last Update Posted: March 4, 2016