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Trial record 69 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)

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: NCT01544920
Recruitment Status : Completed
First Posted : March 6, 2012
Results First Posted : May 30, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Biological: peg-Interferon alfa-2a
Drug: Ribavirin
Drug: Boceprevir
Enrollment 737
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Peg-IFN + RBV Arm 2: BOC + Peg-IFN + RBV
Hide Arm/Group Description Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b]. Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
Period Title: Overall Study
Started 368 369
Completed 349 346
Not Completed 19 23
Reason Not Completed
Adverse Event             0             3
Death             0             1
Lost to Follow-up             11             12
Protocol Violation             0             2
Physician Decision             4             1
Withdrawal by Subject             4             4
Arm/Group Title Arm 1: Peg-IFN + RBV Arm 2: BOC + Peg-IFN + RBV Total
Hide Arm/Group Description Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b]. Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b]. Total of all reporting groups
Overall Number of Baseline Participants 368 369 737
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 368 participants 369 participants 737 participants
43.9  (12.0) 42.4  (12.4) 43.1  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 368 participants 369 participants 737 participants
Female
167
  45.4%
148
  40.1%
315
  42.7%
Male
201
  54.6%
221
  59.9%
422
  57.3%
1.Primary Outcome
Title Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24)
Hide Description SVR24 rates were determined for all participants in Arm 1 and Arm 2. HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.
Time Frame Up to Week 74
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all participants who completed the 4-week peg-IFN + RBV lead-in and who were randomized at Week 4.
Arm/Group Title Arm 1: Peg-IFN + RBV Arm 2: BOC + Peg-IFN + RBV
Hide Arm/Group Description:
Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
Overall Number of Participants Analyzed 368 369
Measure Type: Number
Unit of Measure: Percentage of participants
86.7 88.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Peg-IFN + RBV, Arm 2: BOC + Peg-IFN + RBV
Comments Difference in percentage of participants achieving SVR24
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was declared if the lower bound of the 95% CI of the difference in SVR24 % exceeded -10%.
Method of Estimation Estimation Parameter Difference in SVR24% in Arm 2 vs. Arm 1
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
-3.2 to 6.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24
Hide Description SVR24 rates were determined for only participants that had undetectable HCV RNA at Week 4 of treatment (Arm 1a and Arm 2a). HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all participants who completed the 4-week peg-IFN + RBV lead-in, who were randomized at Week 4, and also had undetectable HCV RNA at Week 4.
Arm/Group Title Arm 1a: Peg-IFN + RBV 24 Weeks Arm 2a: BOC + Peg-IFN + RBV 24 Weeks
Hide Arm/Group Description:
Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of peg-IFN + RBV for a total of 24 weeks of peg-IFN + RBV therapy.
Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of BOC + peg-IFN + RBV for a total of 24 weeks of BOC (added at Week 4) + peg-IFN + RBV therapy.
Overall Number of Participants Analyzed 108 107
Measure Type: Number
Unit of Measure: Percentage of participants
87.0 97.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1a: Peg-IFN + RBV 24 Weeks, Arm 2a: BOC + Peg-IFN + RBV 24 Weeks
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The observed lower bound of the 95% CI for the difference was 2.5% (which exceeds 0) for BOC added to peg-IFN + RBV in contrast to peg-IFN + RBV alone.
Method of Estimation Estimation Parameter Difference in SVR24%
Estimated Value 10.3
Confidence Interval (2-Sided) 95%
2.5 to 18.1
Estimation Comments [Not Specified]
Time Frame Up to 78 weeks
Adverse Event Reporting Description An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The All Participants as Treated (APaT) population includes all participants who received at least one dose of study drug.
 
Arm/Group Title Arm 1: Peg-IFN + RBV Arm 2: BOC + Peg-IFN + RBV
Hide Arm/Group Description Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b]. Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
All-Cause Mortality
Arm 1: Peg-IFN + RBV Arm 2: BOC + Peg-IFN + RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Peg-IFN + RBV Arm 2: BOC + Peg-IFN + RBV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/368 (7.34%)      37/369 (10.03%)    
Blood and lymphatic system disorders     
Anaemia  1  0/368 (0.00%)  0 2/369 (0.54%)  3
Neutropenia  1  3/368 (0.82%)  4 0/369 (0.00%)  0
Pancytopenia  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Thrombocytopenia  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Cardiac disorders     
Atrioventricular block first degree  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Endocrine disorders     
Autoimmune thyroiditis  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Hyperthyroidism  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Abdominal pain upper  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Gastric ulcer  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Haemorrhoids  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Inflammatory bowel disease  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Oral pain  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Pancreatitis  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Pancreatitis acute  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Vomiting  1  0/368 (0.00%)  0 1/369 (0.27%)  2
General disorders     
Malaise  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Pyrexia  1  1/368 (0.27%)  1 2/369 (0.54%)  2
Hepatobiliary disorders     
Cholecystitis  1  1/368 (0.27%)  1 1/369 (0.27%)  1
Cholecystitis chronic  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Infections and infestations     
Bronchitis viral  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Gastroenteritis  1  1/368 (0.27%)  1 2/369 (0.54%)  2
Gastrointestinal infection  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Herpes pharyngitis  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Lobar pneumonia  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Nasopharyngitis  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Perineal abscess  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Peritonsillar abscess  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Pneumonia  1  4/368 (1.09%)  4 3/369 (0.81%)  3
Pulmonary tuberculosis  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Pyelonephritis acute  1  0/368 (0.00%)  0 2/369 (0.54%)  2
Pyelonephritis chronic  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Salmonellosis  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Tooth infection  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Urinary tract infection  1  1/368 (0.27%)  2 0/369 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental overdose  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Alcohol poisoning  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Concussion  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Joint dislocation  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Ligament sprain  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Traumatic haematoma  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Investigations     
Activated partial thromboplastin time prolonged  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Neutrophil count decreased  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Prothrombin time prolonged  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Dehydration  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Osteoarthritis  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Conjunctival melanoma  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Nervous system disorders     
Dizziness  1  0/368 (0.00%)  0 1/369 (0.27%)  2
Headache  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Syncope  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Psychiatric disorders     
Adjustment disorder  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Depression  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Psychotic disorder  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Suicide attempt  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Renal and urinary disorders     
Renal cyst  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Reproductive system and breast disorders     
Uterine haemorrhage  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Lung disorder  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Pleurisy  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Skin and subcutaneous tissue disorders     
Rash  1  1/368 (0.27%)  1 1/369 (0.27%)  1
Social circumstances     
Miscarriage of partner  1  1/368 (0.27%)  1 0/369 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  0/368 (0.00%)  0 1/369 (0.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: Peg-IFN + RBV Arm 2: BOC + Peg-IFN + RBV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   348/368 (94.57%)      351/369 (95.12%)    
Blood and lymphatic system disorders     
Anaemia  1  169/368 (45.92%)  219 168/369 (45.53%)  210
Leukopenia  1  39/368 (10.60%)  66 33/369 (8.94%)  46
Neutropenia  1  109/368 (29.62%)  194 108/369 (29.27%)  161
Thrombocytopenia  1  19/368 (5.16%)  24 24/369 (6.50%)  28
Gastrointestinal disorders     
Abdominal pain  1  18/368 (4.89%)  18 22/369 (5.96%)  26
Abdominal pain upper  1  22/368 (5.98%)  26 14/369 (3.79%)  18
Diarrhoea  1  62/368 (16.85%)  77 49/369 (13.28%)  55
Dry mouth  1  25/368 (6.79%)  26 26/369 (7.05%)  28
Dyspepsia  1  23/368 (6.25%)  25 35/369 (9.49%)  39
Nausea  1  100/368 (27.17%)  117 94/369 (25.47%)  112
Vomiting  1  46/368 (12.50%)  68 53/369 (14.36%)  78
General disorders     
Asthenia  1  82/368 (22.28%)  108 74/369 (20.05%)  90
Chills  1  36/368 (9.78%)  39 26/369 (7.05%)  32
Fatigue  1  118/368 (32.07%)  135 117/369 (31.71%)  154
Influenza like illness  1  34/368 (9.24%)  39 35/369 (9.49%)  48
Pyrexia  1  101/368 (27.45%)  148 148/369 (40.11%)  243
Investigations     
Haemoglobin decreased  1  24/368 (6.52%)  29 31/369 (8.40%)  33
Neutrophil count decreased  1  24/368 (6.52%)  30 29/369 (7.86%)  41
Metabolism and nutrition disorders     
Decreased appetite  1  54/368 (14.67%)  60 53/369 (14.36%)  55
Musculoskeletal and connective tissue disorders     
Arthralgia  1  44/368 (11.96%)  49 45/369 (12.20%)  52
Myalgia  1  61/368 (16.58%)  79 58/369 (15.72%)  74
Nervous system disorders     
Dizziness  1  46/368 (12.50%)  51 42/369 (11.38%)  48
Dysgeusia  1  65/368 (17.66%)  69 94/369 (25.47%)  95
Headache  1  118/368 (32.07%)  152 100/369 (27.10%)  148
Psychiatric disorders     
Anxiety  1  26/368 (7.07%)  29 14/369 (3.79%)  14
Depression  1  29/368 (7.88%)  38 20/369 (5.42%)  22
Insomnia  1  70/368 (19.02%)  73 53/369 (14.36%)  57
Irritability  1  38/368 (10.33%)  43 28/369 (7.59%)  28
Respiratory, thoracic and mediastinal disorders     
Cough  1  66/368 (17.93%)  83 52/369 (14.09%)  56
Dyspnoea  1  34/368 (9.24%)  36 34/369 (9.21%)  38
Oropharyngeal pain  1  11/368 (2.99%)  13 20/369 (5.42%)  22
Skin and subcutaneous tissue disorders     
Alopecia  1  72/368 (19.57%)  76 70/369 (18.97%)  74
Dry skin  1  44/368 (11.96%)  45 41/369 (11.11%)  41
Pruritus  1  75/368 (20.38%)  85 77/369 (20.87%)  84
Rash  1  69/368 (18.75%)  82 67/369 (18.16%)  85
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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 investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01544920     History of Changes
Other Study ID Numbers: P07755
2011-001345-32 ( EudraCT Number )
MK-3034-040 ( Other Identifier: Merck )
CTRI/2012/12/003200 ( Registry Identifier: CTRI )
PHRR131022-000133 ( Registry Identifier: PHRR )
First Submitted: February 28, 2012
First Posted: March 6, 2012
Results First Submitted: April 22, 2016
Results First Posted: May 30, 2016
Last Update Posted: September 11, 2018