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A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)

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ClinicalTrials.gov Identifier: NCT00959699
Recruitment Status : Completed
First Posted : August 17, 2009
Results First Posted : August 30, 2013
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV Infections
Hepatitis C
HCV Infection
Interventions Drug: PegIFN-2b
Drug: RBV
Drug: Placebo to Boceprevir
Drug: Boceprevir
Enrollment 99
Recruitment Details  
Pre-assignment Details One participant in the pegylated interferon alfa-2b (PegIFN-2b) + ribavirin (RBV) + boceprevir group withdrew from the study after randomization but prior to administration of any study treatment.
Arm/Group Title PegIFN-2b + RBV PegIFN-2b + RBV + Boceprevir
Hide Arm/Group Description PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks. PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
Period Title: Treatment Period
Started 34 65
Treated 34 64
Completed 11 [1] 40
Not Completed 23 25
Reason Not Completed
Adverse Event             3             13
Lack of Efficacy             15             6
Lost to Follow-up             0             1
Withdrawal by Subject             1             3
Non-Compliance with Protocol             0             1
Did not receive treatment             0             1
Futility/crossover to boceprevir             4             0
[1]
At TW24, 4 participants not achieving undetectable HCV-RNA crossed-over and received boceprevir.
Period Title: Follow-up Period
Started 33 [1] 62 [2]
Completed 27 56
Not Completed 6 6
Reason Not Completed
Lost to Follow-up             3             2
Withdrawal by Subject             3             4
[1]
1 participant didn't enter Follow-up; participants discontinuing treatment could enter Follow-up.
[2]
2 participants didn't enter Follow-up; participants discontinuing treatment could enter Follow-up.
Arm/Group Title PegIFN-2b + RBV PegIFN-2b + RBV + Boceprevir Total
Hide Arm/Group Description PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks. PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up. Total of all reporting groups
Overall Number of Baseline Participants 34 64 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 64 participants 98 participants
45.1  (9.8) 42.9  (8.3) 43.6  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 64 participants 98 participants
Female
12
  35.3%
18
  28.1%
30
  30.6%
Male
22
  64.7%
46
  71.9%
68
  69.4%
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication
Hide Description SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.
Arm/Group Title PegIFN-2b + RBV PegIFN-2b + RBV + Boceprevir
Hide Arm/Group Description:
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 34 64
Measure Type: Number
Unit of Measure: percentage of participants
29.4 62.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PegIFN-2b + RBV, PegIFN-2b + RBV + Boceprevir
Comments The methodology for 95% Confidence Interval (CI) is based on a Modified Koch approach which adjusted for Randomization Strata of Cirrhosis/Fibrosis (Yes or No). The adjustment of randomization strata of HCV-RNA (< or >= 800,000 IU/mL) was not possible due to sparse data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (< or >= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Strata-Adjusted Difference
Estimated Value 33.7
Confidence Interval (2-Sided) 95%
14.1 to 53.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control)
Hide Description SVR24 is defined as undetectable plasma HCV-RNA 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from FW12 was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving one dose of boceprevir (PegIFN-2b + RBV + Boceprevir group) or placebo to boceprevir (PegIFN-2b + RBV group), defined as the Modified Intent-to-Treat Population; this includes 2 participants who did not enter the Follow-up Period.
Arm/Group Title PegIFN-2b + RBV PegIFN-2b + RBV + Boceprevir
Hide Arm/Group Description:
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 33 62
Measure Type: Number
Unit of Measure: percentage of participants
30.3 64.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PegIFN-2b + RBV, PegIFN-2b + RBV + Boceprevir
Comments The methodology for 95% CI is based on the asymptotic normal approximation to the binomial distribution
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (< or >= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Observed Difference
Estimated Value 34.2
Confidence Interval (2-Sided) 95%
14.5 to 53.9
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24
Hide Description EVR was defined as undetectable HCV-RNA at Treatment Week (TW) 2, 4, 8, or 12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period. No participants had undetectable HCV-RNA at Week 2; the "n" value in the table below represents the number of participants with EVR at that time point.
Arm/Group Title PegIFN-2b + RBV PegIFN-2b + RBV + Boceprevir
Hide Arm/Group Description:
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 34 64
Measure Type: Number
Unit of Measure: percentage of participants
HCV-RNA undetectable at Week 2 (n=0, 0) 0 0
HCV-RNA undetectable at Week 4 (n=3, 3) 100 100
HCV-RNA undetectable at Week 8 (n=5, 27) 100 92.6
HCV-RNA undetectable at Week 12 (n=8, 38) 87.5 92.1
4.Secondary Outcome
Title Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12)
Hide Description The virologic response at FW12 was considered SVR12 with an additional rule for handling missing data: participants with missing HCV-RNA assessment at FW12 but having non-missing, undetectable HCV-RNA assessments at both FW4 and FW24, were assumed to be responders for SVR12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Time Frame Up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.
Arm/Group Title PegIFN-2b + RBV PegIFN-2b + RBV + Boceprevir
Hide Arm/Group Description:
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 34 64
Measure Type: Number
Unit of Measure: percentage of participants
26.5 62.5
5.Secondary Outcome
Title Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)
Hide Description This is a measure of the change in the amount of HCV-RNA in the plasma at the end of 4 weeks of treatment. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.
Arm/Group Title PegIFN-2b + RBV PegIFN-2b + RBV + Boceprevir
Hide Arm/Group Description:
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 34 64
Measure Type: Number
Unit of Measure: participants
Participants with <1 positive log drop 15 28
Participants with >= 1 positive log drop 16 32
Participants with undetectable HCV-RNA 3 3
Participants with missing data 0 1
6.Secondary Outcome
Title Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound
Hide Description Virologic breakthrough is defined as achieving undetectable HCV-RNA and subsequently having an HCV-RNA level of >1000 IU/mL. Incomplete Virologic Response/Rebound is defined as having a one log10 increase in HCV-RNA from the participant's nadir, with an HCV-RNA >1000 IU/mL. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.
Arm/Group Title PegIFN-2b + RBV PegIFN-2b + RBV + Boceprevir
Hide Arm/Group Description:
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 34 64
Measure Type: Number
Unit of Measure: percentage of participants
Virologic breakthrough 0 6.3
Incomplete response 17.6 9.4
Time Frame Adverse events were collected from randomization through Week 72.
Adverse Event Reporting Description

One participant randomized to the boceprevir arm never received study drug.

Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
 
Arm/Group Title PegIFN-2b+RBV PegIFN-2b+RBV+Boceprevir Boceprevir Crossover
Hide Arm/Group Description PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks. PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up. (After Treatment Week 24) PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) plus boceprevir (800 mg, orally, 3 times per day) for up to 44 weeks with 24 weeks post-treatment follow-up.
All-Cause Mortality
PegIFN-2b+RBV PegIFN-2b+RBV+Boceprevir Boceprevir Crossover
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
PegIFN-2b+RBV PegIFN-2b+RBV+Boceprevir Boceprevir Crossover
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/34 (20.59%)      11/64 (17.19%)      0/4 (0.00%)    
Blood and lymphatic system disorders       
ANAEMIA † 1  2/34 (5.88%)  2 2/64 (3.13%)  3 0/4 (0.00%)  0
LYMPHADENOPATHY † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
Cardiac disorders       
VENTRICULAR FIBRILLATION † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal disorders       
ABDOMINAL PAIN UPPER † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
PANCREATITIS † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
Hepatobiliary disorders       
CHOLELITHIASIS † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
Infections and infestations       
LUNG INFECTION PSEUDOMONAL † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
PELVIC INFLAMMATORY DISEASE † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
PNEUMONIA † 1  0/34 (0.00%)  0 2/64 (3.13%)  2 0/4 (0.00%)  0
POST PROCEDURAL INFECTION † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
SINUSITIS † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
URINARY TRACT INFECTION † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
VULVAL ABSCESS † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
Injury, poisoning and procedural complications       
LIGAMENT RUPTURE † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
MENISCUS LESION † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
OVERDOSE † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
Metabolism and nutrition disorders       
LACTIC ACIDOSIS † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders       
ARTHRALGIA † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
Nervous system disorders       
SYNCOPE † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
Psychiatric disorders       
DEPRESSION † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
SUICIDE ATTEMPT † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
Renal and urinary disorders       
RENAL FAILURE † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
RENAL FAILURE ACUTE † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
PULMONARY EMBOLISM † 1  0/34 (0.00%)  0 2/64 (3.13%)  2 0/4 (0.00%)  0
PULMONARY HYPERTENSION † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
RESPIRATORY FAILURE † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
Surgical and medical procedures       
CHOLECYSTECTOMY † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 0/4 (0.00%)  0
Vascular disorders       
DEEP VEIN THROMBOSIS † 1  0/34 (0.00%)  0 1/64 (1.56%)  1 0/4 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PegIFN-2b+RBV PegIFN-2b+RBV+Boceprevir Boceprevir Crossover
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/34 (97.06%)      62/64 (96.88%)      4/4 (100.00%)    
Blood and lymphatic system disorders       
ANAEMIA † 1  8/34 (23.53%)  8 26/64 (40.63%)  40 2/4 (50.00%)  2
NEUTROPENIA † 1  2/34 (5.88%)  2 12/64 (18.75%)  14 1/4 (25.00%)  1
THROMBOCYTOPENIA † 1  0/34 (0.00%)  0 5/64 (7.81%)  5 1/4 (25.00%)  1
Cardiac disorders       
PALPITATIONS † 1  0/34 (0.00%)  0 2/64 (3.13%)  2 1/4 (25.00%)  1
Congenital, familial and genetic disorders       
PORPHYRIA † 1  0/34 (0.00%)  0 0/64 (0.00%)  0 1/4 (25.00%)  1
Eye disorders       
DRY EYE † 1  2/34 (5.88%)  2 2/64 (3.13%)  3 0/4 (0.00%)  0
Gastrointestinal disorders       
ABDOMINAL DISCOMFORT † 1  0/34 (0.00%)  0 2/64 (3.13%)  2 1/4 (25.00%)  1
ABDOMINAL PAIN † 1  3/34 (8.82%)  3 3/64 (4.69%)  3 0/4 (0.00%)  0
ABDOMINAL PAIN UPPER † 1  1/34 (2.94%)  1 6/64 (9.38%)  7 0/4 (0.00%)  0
APHTHOUS STOMATITIS † 1  0/34 (0.00%)  0 6/64 (9.38%)  6 0/4 (0.00%)  0
CHEILITIS † 1  2/34 (5.88%)  2 5/64 (7.81%)  6 1/4 (25.00%)  1
CONSTIPATION † 1  5/34 (14.71%)  5 4/64 (6.25%)  4 1/4 (25.00%)  1
DIARRHOEA † 1  6/34 (17.65%)  8 21/64 (32.81%)  30 0/4 (0.00%)  0
DRY MOUTH † 1  0/34 (0.00%)  0 5/64 (7.81%)  5 0/4 (0.00%)  0
NAUSEA † 1  11/34 (32.35%)  12 26/64 (40.63%)  37 1/4 (25.00%)  1
ORAL PAIN † 1  0/34 (0.00%)  0 4/64 (6.25%)  4 0/4 (0.00%)  0
RECTAL HAEMORRHAGE † 1  0/34 (0.00%)  0 0/64 (0.00%)  0 1/4 (25.00%)  1
TONGUE DISCOLOURATION † 1  2/34 (5.88%)  2 0/64 (0.00%)  0 0/4 (0.00%)  0
VOMITING † 1  5/34 (14.71%)  9 18/64 (28.13%)  23 0/4 (0.00%)  0
General disorders       
ASTHENIA † 1  9/34 (26.47%)  9 22/64 (34.38%)  30 2/4 (50.00%)  2
CHILLS † 1  5/34 (14.71%)  5 5/64 (7.81%)  5 0/4 (0.00%)  0
FATIGUE † 1  12/34 (35.29%)  15 25/64 (39.06%)  35 0/4 (0.00%)  0
INFLUENZA LIKE ILLNESS † 1  13/34 (38.24%)  29 16/64 (25.00%)  24 0/4 (0.00%)  0
INJECTION SITE ERYTHEMA † 1  1/34 (2.94%)  1 4/64 (6.25%)  4 0/4 (0.00%)  0
IRRITABILITY † 1  5/34 (14.71%)  5 10/64 (15.63%)  11 1/4 (25.00%)  1
MALAISE † 1  2/34 (5.88%)  2 3/64 (4.69%)  3 0/4 (0.00%)  0
OEDEMA PERIPHERAL † 1  2/34 (5.88%)  2 3/64 (4.69%)  3 0/4 (0.00%)  0
PAIN † 1  1/34 (2.94%)  1 5/64 (7.81%)  5 0/4 (0.00%)  0
PYREXIA † 1  7/34 (20.59%)  13 24/64 (37.50%)  60 1/4 (25.00%)  1
Infections and infestations       
FOLLICULITIS † 1  2/34 (5.88%)  2 0/64 (0.00%)  0 0/4 (0.00%)  0
GINGIVAL ABSCESS † 1  0/34 (0.00%)  0 0/64 (0.00%)  0 1/4 (25.00%)  1
INFLUENZA † 1  4/34 (11.76%)  5 6/64 (9.38%)  7 0/4 (0.00%)  0
NASOPHARYNGITIS † 1  4/34 (11.76%)  4 5/64 (7.81%)  5 0/4 (0.00%)  0
ORAL CANDIDIASIS † 1  2/34 (5.88%)  2 3/64 (4.69%)  5 0/4 (0.00%)  0
RESPIRATORY TRACT INFECTION † 1  1/34 (2.94%)  1 2/64 (3.13%)  3 1/4 (25.00%)  1
SINUSITIS † 1  0/34 (0.00%)  0 5/64 (7.81%)  6 1/4 (25.00%)  1
UPPER RESPIRATORY TRACT INFECTION † 1  2/34 (5.88%)  2 1/64 (1.56%)  1 0/4 (0.00%)  0
URINARY TRACT INFECTION † 1  2/34 (5.88%)  2 3/64 (4.69%)  3 0/4 (0.00%)  0
Investigations       
GAMMA-GLUTAMYLTRANSFERASE INCREASED † 1  2/34 (5.88%)  2 0/64 (0.00%)  0 0/4 (0.00%)  0
TRANSAMINASES INCREASED † 1  2/34 (5.88%)  2 0/64 (0.00%)  0 0/4 (0.00%)  0
WEIGHT DECREASED † 1  1/34 (2.94%)  1 8/64 (12.50%)  9 0/4 (0.00%)  0
Metabolism and nutrition disorders       
DECREASED APPETITE † 1  6/34 (17.65%)  6 22/64 (34.38%)  22 0/4 (0.00%)  0
HYPERTRIGLYCERIDAEMIA † 1  2/34 (5.88%)  2 2/64 (3.13%)  3 1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders       
ARTHRALGIA † 1  2/34 (5.88%)  2 7/64 (10.94%)  7 0/4 (0.00%)  0
MYALGIA † 1  6/34 (17.65%)  7 9/64 (14.06%)  12 0/4 (0.00%)  0
NECK PAIN † 1  2/34 (5.88%)  2 2/64 (3.13%)  2 0/4 (0.00%)  0
PAIN IN EXTREMITY † 1  2/34 (5.88%)  2 3/64 (4.69%)  3 0/4 (0.00%)  0
Nervous system disorders       
DIZZINESS † 1  2/34 (5.88%)  2 8/64 (12.50%)  9 1/4 (25.00%)  1
DYSGEUSIA † 1  5/34 (14.71%)  5 18/64 (28.13%)  18 2/4 (50.00%)  2
HEADACHE † 1  6/34 (17.65%)  6 18/64 (28.13%)  63 0/4 (0.00%)  0
PARAESTHESIA † 1  2/34 (5.88%)  2 2/64 (3.13%)  2 0/4 (0.00%)  0
SOMNOLENCE † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 1/4 (25.00%)  1
Pregnancy, puerperium and perinatal conditions       
PREGNANCY † 1  0/34 (0.00%)  0 0/64 (0.00%)  0 1/4 (25.00%)  1
Psychiatric disorders       
AFFECT LABILITY † 1  2/34 (5.88%)  2 1/64 (1.56%)  1 1/4 (25.00%)  1
ANXIETY † 1  5/34 (14.71%)  8 10/64 (15.63%)  11 0/4 (0.00%)  0
APATHY † 1  1/34 (2.94%)  1 0/64 (0.00%)  0 1/4 (25.00%)  1
DEPRESSED MOOD † 1  1/34 (2.94%)  2 1/64 (1.56%)  1 1/4 (25.00%)  1
DEPRESSION † 1  4/34 (11.76%)  4 11/64 (17.19%)  11 0/4 (0.00%)  0
DRUG ABUSE † 1  2/34 (5.88%)  2 0/64 (0.00%)  0 0/4 (0.00%)  0
INSOMNIA † 1  9/34 (26.47%)  12 15/64 (23.44%)  17 0/4 (0.00%)  0
NERVOUSNESS † 1  1/34 (2.94%)  1 1/64 (1.56%)  1 1/4 (25.00%)  1
SLEEP DISORDER † 1  1/34 (2.94%)  1 5/64 (7.81%)  5 0/4 (0.00%)  0
Reproductive system and breast disorders       
METRORRHAGIA † 1  2/34 (5.88%)  2 0/64 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
COUGH † 1  6/34 (17.65%)  6 9/64 (14.06%)  10 0/4 (0.00%)  0
DYSPNOEA † 1  2/34 (5.88%)  2 5/64 (7.81%)  5 0/4 (0.00%)  0
DYSPNOEA EXERTIONAL † 1  2/34 (5.88%)  2 5/64 (7.81%)  5 0/4 (0.00%)  0
OROPHARYNGEAL PAIN † 1  2/34 (5.88%)  2 5/64 (7.81%)  7 0/4 (0.00%)  0
PRODUCTIVE COUGH † 1  2/34 (5.88%)  2 0/64 (0.00%)  0 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders       
ALOPECIA † 1  6/34 (17.65%)  6 12/64 (18.75%)  12 0/4 (0.00%)  0
DRY SKIN † 1  3/34 (8.82%)  4 8/64 (12.50%)  11 0/4 (0.00%)  0
ERYTHEMA † 1  1/34 (2.94%)  1 4/64 (6.25%)  4 0/4 (0.00%)  0
PRURITUS † 1  3/34 (8.82%)  4 13/64 (20.31%)  16 1/4 (25.00%)  1
RASH † 1  0/34 (0.00%)  0 5/64 (7.81%)  5 0/4 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
[Not Specified]
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 must provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc.) that report any results of the trial. The sponsor shall have the right to review and comment.
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.
EMail: ClinicalTrialsDisclosure@merck.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00959699    
Other Study ID Numbers: P05411
MK-3034-025 ( Other Identifier: Merck study number )
First Submitted: July 29, 2009
First Posted: August 17, 2009
Results First Submitted: May 8, 2013
Results First Posted: August 30, 2013
Last Update Posted: April 7, 2017