Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 28 for:    RNA | BI 201335 OR faldaprevir

IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01732796
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : April 18, 2016
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Ribavirin (RBV)
Drug: BI 201335 (Faldaprevir)
Drug: BI 207127
Drug: Faldaprevir (BI 201335)
Enrollment 470
Recruitment Details It was planned that approximately 800 patients would be screened in order to randomize and treat approximately 460 patients (195 patients in treatment Groups 1 and 2 each, 40-70 patients in treatment Group 3).
Pre-assignment Details Treatment-naïve patients with chronic hepatitis C infection of genotype (GT)1b were included in the trial. Patients with compensated liver cirrhosis, defined as Ishak Grade ≥5 or METAVIR Grade ≥4 on liver biopsy, or liver stiffness of ≥ 13 kilopascal (kPa) on fibroscan, were assigned to Group 3.
Arm/Group Title 16 wk NC FDV+DBV+RBV 24 wk NC FDV+DBV+RBV 24 wk CR FDV+DBV+RBV
Hide Arm/Group Description

600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin BID (RBV) for 16 weeks (wk) followed by DBV placebo, FDV placebo and RBV placebo for 8 weeks. All were administered per os (orally).

This group included non-cirrhotic patients (NC).

600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally).

This group included non-cirrhotic patients (NC).

600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
Period Title: Overall Study
Started 208 211 51
Completed 162 169 38
Not Completed 46 42 13
Reason Not Completed
Adverse Event             16             16             4
Lack of Efficacy             21             18             5
Lost to Follow-up             2             0             0
Withdrawal by Subject             6             8             2
Other reason not defined above             1             0             2
Arm/Group Title 16 wk NC FDV+DBV+RBV 24 wk NC FDV+DBV+RBV 24 wk CR FDV+DBV+RBV Total
Hide Arm/Group Description

600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).

This group included non-cirrhotic patients (NC).

600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC). 600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment. Total of all reporting groups
Overall Number of Baseline Participants 208 211 51 470
Hide Baseline Analysis Population Description
The baseline characteristics were carried out on an intent-to-treat basis including all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication (FAS).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 208 participants 211 participants 51 participants 470 participants
50.1  (12.7) 51.1  (12.9) 57.9  (8.8) 51.4  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 211 participants 51 participants 470 participants
Female
122
  58.7%
114
  54.0%
18
  35.3%
254
  54.0%
Male
86
  41.3%
97
  46.0%
33
  64.7%
216
  46.0%
1.Primary Outcome
Title SVR12 Rates With Historical Control
Hide Description Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level <25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint
Time Frame 12 Week (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analyses of efficacy were carried out on an intent-to-treat basis including all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication (FAS).
Arm/Group Title 24 wk FDV+DBV+RBV 16 wk FDV+DBV+RBV
Hide Arm/Group Description:
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk (orally) in cirrhotic and non-cirrhotic patients.
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID), orally. This is the combination of non-cirrhotic patients in the 16 week treatment group and cirrhosis patients in the 24-week treatment group.
Overall Number of Participants Analyzed 262 259
Measure Type: Number
Unit of Measure: Percentage of participants
non-cirrhotic (N=174, 149) 82.5 71.6
cirrhotic (N=37, 37) 72.5 72.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 24 wk FDV+DBV+RBV
Comments The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Stratified one sample z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted response rate
Estimated Value 81.4
Confidence Interval (2-Sided) 95%
76.6 to 86.2
Estimation Comments Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 16 wk FDV+DBV+RBV
Comments The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3989
Comments [Not Specified]
Method Stratified one sample z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted response rate
Estimated Value 71.7
Confidence Interval (2-Sided) 95%
66.1 to 77.4
Estimation Comments Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN
2.Primary Outcome
Title Comparisons of SVR12 Rates Across Treatment Arms
Hide Description Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
Time Frame 12 Week (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 16 wk NC FDV+DBV+RBV 24 wk NC FDV+DBV+RBV 24 wk CR FDV+DBV+RBV
Hide Arm/Group Description:
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
Overall Number of Participants Analyzed 208 211 51
Measure Type: Number
Unit of Measure: Percentage of participants
71.6 82.5 72.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 16 wk NC FDV+DBV+RBV, 24 wk NC FDV+DBV+RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0040
Comments [Not Specified]
Method z-test
Comments based on two sample z-test with continuity correction for variance.
Method of Estimation Estimation Parameter Koch's method with continuity correction
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
2.8 to 18.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title SVR4
Hide Description Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).
Time Frame 4 Week (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 16 wk NC FDV+DBV+RBV 24 wk NC FDV+DBV+RBV 24 wk CR FDV+DBV+RBV
Hide Arm/Group Description:
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
Overall Number of Participants Analyzed 208 211 51
Measure Type: Number
Unit of Measure: Percentage of participants
Percentage of patients with response 78.4 84.4 76.5
Positive predicted value 94.0 98.0 95.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 16 wk NC FDV+DBV+RBV, 24 wk NC FDV+DBV+RBV
Comments Category: Percentage of patient with response
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0575
Comments [Not Specified]
Method z-test
Comments based on two sample z-test with continuity correction for variance.
Method of Estimation Estimation Parameter Koch's method with continuity correction
Estimated Value 6.0
Confidence Interval (2-Sided) 95%
-1.5 to 13.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title SVR24
Hide Description Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).
Time Frame 24 Week (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 16 wk NC FDV+DBV+RBV 24 wk NC FDV+DBV+RBV 24 wk CR FDV+DBV+RBV
Hide Arm/Group Description:
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
Overall Number of Participants Analyzed 208 211 51
Measure Type: Number
Unit of Measure: Percantage of participants
Percentage of patients with response 70.7 80.6 72.5
Positive predicted value 97.0 99.0 100.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 16 wk NC FDV+DBV+RBV, 24 wk NC FDV+DBV+RBV
Comments Category: Percentage of patient with response
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0089
Comments [Not Specified]
Method z-test
Comments based on two sample z-test with continuity correction for variance.
Method of Estimation Estimation Parameter Koch's method with continuity correction
Estimated Value 9.9
Confidence Interval (2-Sided) 95%
1.7 to 18.1
Estimation Comments [Not Specified]
Time Frame From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Adverse Event Reporting Description Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
 
Arm/Group Title 16 wk NC FDV+DBV+RBV 24 wk NC FDV+DBV+RBV 24 wk CR FDV+DBV+RBV
Hide Arm/Group Description

600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).

This group included non-cirrhotic patients (NC).

600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC). 600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
All-Cause Mortality
16 wk NC FDV+DBV+RBV 24 wk NC FDV+DBV+RBV 24 wk CR FDV+DBV+RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
16 wk NC FDV+DBV+RBV 24 wk NC FDV+DBV+RBV 24 wk CR FDV+DBV+RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/208 (3.37%)   11/211 (5.21%)   4/51 (7.84%) 
Blood and lymphatic system disorders       
Agranulocytosis  1  1/208 (0.48%)  1/211 (0.47%)  0/51 (0.00%) 
Anaemia  1  1/208 (0.48%)  2/211 (0.95%)  0/51 (0.00%) 
Febrile neutropenia  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Cardiac disorders       
Pericarditis  1  1/208 (0.48%)  0/211 (0.00%)  0/51 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  0/208 (0.00%)  0/211 (0.00%)  1/51 (1.96%) 
Duodenal ulcer  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Gastrointestinal haemorrhage  1  0/208 (0.00%)  0/211 (0.00%)  1/51 (1.96%) 
Gastrooesophageal reflux disease  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
General disorders       
Fatigue  1  1/208 (0.48%)  0/211 (0.00%)  0/51 (0.00%) 
Pyrexia  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis  1  0/208 (0.00%)  0/211 (0.00%)  1/51 (1.96%) 
Hyperbilirubinaemia  1  0/208 (0.00%)  0/211 (0.00%)  1/51 (1.96%) 
Infections and infestations       
Escherichia urinary tract infection  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Gastritis bacterial  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Gingivitis  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Injury, poisoning and procedural complications       
Dumping syndrome  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Fall  1  1/208 (0.48%)  1/211 (0.47%)  0/51 (0.00%) 
Multiple injuries  1  1/208 (0.48%)  0/211 (0.00%)  0/51 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  1/208 (0.48%)  0/211 (0.00%)  0/51 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Non-Hodgkin's lymphoma  1  1/208 (0.48%)  0/211 (0.00%)  0/51 (0.00%) 
Pancreatic carcinoma  1  1/208 (0.48%)  0/211 (0.00%)  0/51 (0.00%) 
Nervous system disorders       
Dizziness  1  1/208 (0.48%)  0/211 (0.00%)  0/51 (0.00%) 
Loss of consciousness  1  1/208 (0.48%)  0/211 (0.00%)  0/51 (0.00%) 
Syncope  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Psychiatric disorders       
Depression  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Drug abuse  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Psychotic disorder  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Renal and urinary disorders       
Prerenal failure  1  0/208 (0.00%)  0/211 (0.00%)  1/51 (1.96%) 
Renal failure acute  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Urethral stenosis  1  0/208 (0.00%)  0/211 (0.00%)  1/51 (1.96%) 
Vascular disorders       
Haematoma  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Thrombosis  1  0/208 (0.00%)  1/211 (0.47%)  0/51 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
16 wk NC FDV+DBV+RBV 24 wk NC FDV+DBV+RBV 24 wk CR FDV+DBV+RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   192/208 (92.31%)   198/211 (93.84%)   49/51 (96.08%) 
Blood and lymphatic system disorders       
Anaemia  1  40/208 (19.23%)  53/211 (25.12%)  19/51 (37.25%) 
Eye disorders       
Ocular icterus  1  20/208 (9.62%)  15/211 (7.11%)  3/51 (5.88%) 
Gastrointestinal disorders       
Abdominal discomfort  1  14/208 (6.73%)  10/211 (4.74%)  3/51 (5.88%) 
Abdominal pain  1  14/208 (6.73%)  16/211 (7.58%)  4/51 (7.84%) 
Abdominal pain upper  1  25/208 (12.02%)  27/211 (12.80%)  2/51 (3.92%) 
Constipation  1  12/208 (5.77%)  14/211 (6.64%)  3/51 (5.88%) 
Diarrhoea  1  50/208 (24.04%)  66/211 (31.28%)  17/51 (33.33%) 
Dyspepsia  1  24/208 (11.54%)  25/211 (11.85%)  5/51 (9.80%) 
Nausea  1  96/208 (46.15%)  112/211 (53.08%)  27/51 (52.94%) 
Vomiting  1  64/208 (30.77%)  62/211 (29.38%)  18/51 (35.29%) 
General disorders       
Asthenia  1  40/208 (19.23%)  58/211 (27.49%)  7/51 (13.73%) 
Chest pain  1  5/208 (2.40%)  3/211 (1.42%)  3/51 (5.88%) 
Chills  1  5/208 (2.40%)  3/211 (1.42%)  3/51 (5.88%) 
Fatigue  1  53/208 (25.48%)  50/211 (23.70%)  13/51 (25.49%) 
Pyrexia  1  6/208 (2.88%)  6/211 (2.84%)  4/51 (7.84%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  17/208 (8.17%)  17/211 (8.06%)  5/51 (9.80%) 
Jaundice  1  28/208 (13.46%)  35/211 (16.59%)  10/51 (19.61%) 
Infections and infestations       
Nasopharyngitis  1  12/208 (5.77%)  13/211 (6.16%)  4/51 (7.84%) 
Injury, poisoning and procedural complications       
Sunburn  1  9/208 (4.33%)  17/211 (8.06%)  4/51 (7.84%) 
Investigations       
Blood bilirubin increased  1  8/208 (3.85%)  10/211 (4.74%)  5/51 (9.80%) 
Weight decreased  1  13/208 (6.25%)  19/211 (9.00%)  5/51 (9.80%) 
Metabolism and nutrition disorders       
Decreased appetite  1  20/208 (9.62%)  33/211 (15.64%)  6/51 (11.76%) 
Vitamin D deficiency  1  14/208 (6.73%)  21/211 (9.95%)  1/51 (1.96%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  13/208 (6.25%)  11/211 (5.21%)  1/51 (1.96%) 
Back pain  1  13/208 (6.25%)  6/211 (2.84%)  1/51 (1.96%) 
Nervous system disorders       
Dizziness  1  13/208 (6.25%)  18/211 (8.53%)  5/51 (9.80%) 
Dysgeusia  1  11/208 (5.29%)  8/211 (3.79%)  4/51 (7.84%) 
Headache  1  33/208 (15.87%)  30/211 (14.22%)  4/51 (7.84%) 
Paraesthesia  1  11/208 (5.29%)  17/211 (8.06%)  2/51 (3.92%) 
Syncope  1  0/208 (0.00%)  8/211 (3.79%)  3/51 (5.88%) 
Psychiatric disorders       
Depression  1  11/208 (5.29%)  18/211 (8.53%)  1/51 (1.96%) 
Insomnia  1  17/208 (8.17%)  29/211 (13.74%)  10/51 (19.61%) 
Irritability  1  6/208 (2.88%)  14/211 (6.64%)  2/51 (3.92%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  13/208 (6.25%)  17/211 (8.06%)  7/51 (13.73%) 
Dyspnoea  1  14/208 (6.73%)  18/211 (8.53%)  4/51 (7.84%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  18/208 (8.65%)  9/211 (4.27%)  2/51 (3.92%) 
Dry skin  1  18/208 (8.65%)  13/211 (6.16%)  2/51 (3.92%) 
Erythema  1  23/208 (11.06%)  28/211 (13.27%)  8/51 (15.69%) 
Photosensitivity reaction  1  29/208 (13.94%)  30/211 (14.22%)  10/51 (19.61%) 
Pruritus  1  38/208 (18.27%)  53/211 (25.12%)  20/51 (39.22%) 
Rash  1  35/208 (16.83%)  37/211 (17.54%)  11/51 (21.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
BI stopped the further development of DBV, per protocol amendment the Follow-up period was reduced to 24 weeks for patients who achieved SVR12, and to 48 weeks for SVR12 non-responders provided they had not started an alternative HCV treatment.
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01732796     History of Changes
Other Study ID Numbers: 1241.20
2012-003533-41 ( EudraCT Number: EudraCT )
First Submitted: November 6, 2012
First Posted: November 26, 2012
Results First Submitted: January 21, 2016
Results First Posted: April 18, 2016
Last Update Posted: April 18, 2016