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Trial record 4 of 382 for:    IFNA2 AND RBV AND genotype

Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C

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: NCT01467492
Recruitment Status : Terminated (It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.)
First Posted : November 8, 2011
Results First Posted : June 16, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Telaprevir
Drug: Ribavirin
Biological: Pegylated Interferon Alfa-2a
Enrollment 121
Recruitment Details Study included Prior Relapser (prior HCV treatment with pegylated interferon alfa/ribavirin [Peg-IFN/RBV] and experienced viral relapse) and Prior Null/Partial Responder (prior HCV treatment with Peg-IFN/RBV and had null/partial response) participants.
Pre-assignment Details Efficacy analyses were reported as per Race (Black/Non-Black) (reporting arms) and also separately as per prior response (in categories) (Prior Relapser, Prior Null Responder, Prior Partial Responder as well as for Total Participants), unless otherwise specified.
Arm/Group Title Group A - Black Group B – Non-Black
Hide Arm/Group Description Black/African American participants received telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing <75 kilograms [kg]) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Period Title: Overall Study
Started 83 38
Completed 61 25
Not Completed 22 13
Reason Not Completed
Withdrawal by Subject             6             4
Study Terminated by Sponsor             6             4
Adverse Event             4             3
Lost to Follow-up             3             2
Undefined             2             0
Enrolled But Not Treated             1             0
Arm/Group Title Group A - Black Group B – Non-Black Total
Hide Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 82 38 120
Hide Baseline Analysis Population Description
Full Analysis (FA) Set included all enrolled participants who received at least 1 dose of any study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 38 participants 120 participants
57.7  (5.59) 55.8  (5.95) 57.1  (5.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 38 participants 120 participants
Female
34
  41.5%
6
  15.8%
40
  33.3%
Male
48
  58.5%
32
  84.2%
80
  66.7%
1.Primary Outcome
Title Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
Hide Description SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
Time Frame 12 weeks after last actual dose of study drug (up to Week 60)
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.
Arm/Group Title Group A - Black Group B – Non-Black
Hide Arm/Group Description:
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Overall Number of Participants Analyzed 82 38
Measure Type: Number
Unit of Measure: percentage of participants
Prior Null Response (n = 41, 10) 26.8 20.0
Prior Partial Response (n= 20, 6) 40.0 33.3
Prior Relapse ( n= 21, 22) 66.7 59.1
Total (n= 82, 38) 40.2 44.7
2.Secondary Outcome
Title Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
Hide Description SVR24 was defined as an undetectable HCV RNA Levels (<lower limit of quantification) at 24 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.
Time Frame 24 weeks after last actual dose of study drug (up to Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.
Arm/Group Title Group A - Black Group B – Non-Black
Hide Arm/Group Description:
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Overall Number of Participants Analyzed 82 38
Measure Type: Number
Unit of Measure: percentage of participants
Prior Null Response (n = 41, 10) 19.5 20.0
Prior Partial Response (n= 20, 6) 30.0 16.7
Prior Relapse ( n= 21, 22) 61.9 50.0
Total (n= 82, 38) 32.9 36.8
3.Secondary Outcome
Title Percentage of Participants With Extended Rapid Viral Response (eRVR)
Hide Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.
Time Frame Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.
Arm/Group Title Group A - Black Group B – Non-Black
Hide Arm/Group Description:
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Overall Number of Participants Analyzed 82 38
Measure Type: Number
Unit of Measure: percentage of participants
Prior Null Response (n = 41, 10) 24.4 30.0
Prior Partial Response (n= 20, 6) 45.0 66.7
Prior Relapse ( n= 21, 22) 66.7 68.2
Total (n= 82, 38) 40.2 57.9
4.Secondary Outcome
Title Percentage of Participants With Relapse
Hide Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (>=lower limit of quantification) during follow-up.
Time Frame 4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set. Here number of participants analyzed signifies participants with undetectable HCV RNA (HCV RNA <lower limit of quantification) at actual EOT and n signifies participants with undetectable HCV RNA at actual EOT for specified category.
Arm/Group Title Group A - Black Group B – Non-Black
Hide Arm/Group Description:
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Overall Number of Participants Analyzed 48 26
Measure Type: Number
Unit of Measure: percentage of participants
Prior Null Response, 4 Wk After EOT (n=17,3) 23.5 33.3
Prior Null Response, 12 Wk After EOT (n=17,3) 23.5 33.3
Prior Null Response, 24 Wk After EOT (n=17,3) 29.4 33.3
Prior Partial Response, 4Wk After EOT (n=13,4) 15.4 50.0
Prior Partial Response, 12 Wk After EOT (n=13,4) 23.1 50.0
Prior Partial Response, 24 Wk After EOT (n=13,4) 23.1 50.0
Prior Relapse, 4 Wk After EOT (n=18,19) 11.1 15.8
Prior Relapse, 12 Wk After EOT (n=18,19) 11.1 26.3
Prior Relapse, 24 Wk After EOT (n=18,19) 11.1 26.3
Total, 4 Wk After EOT (n=48,26) 16.7 23.1
Total, 12 Wk After EOT (n=48,26) 18.8 30.8
Total, 24 Wk After EOT (n=48,26) 20.8 30.8
5.Secondary Outcome
Title Percentage of Participants With Virologic Breakthrough
Hide Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (>=lower limit of quantification) after undetectable HCV RNA (<lower limit of quantification). Percentages are calculated by using total number in FA set as denominator, in each category.
Time Frame Week 2, 4, 8, and 12
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Hide Analysis Population Description
FA Set.
Arm/Group Title Group A - Black Group B – Non-Black
Hide Arm/Group Description:
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Overall Number of Participants Analyzed 82 38
Measure Type: Number
Unit of Measure: percentage of participants
Prior Null Response, Week 2 0 0
Prior Null Response, Week 4 1.2 2.6
Prior Null Response, Week 8 3.7 5.3
Prior Null Response, Week 12 6.1 5.3
Prior Partial Response, Week 2 0 0
Prior Partial Response, Week 4 2.4 0
Prior Partial Response, Week 8 2.4 0
Prior Partial Response, Week 12 2.4 0
Prior Relapse, Week 2 0 0
Prior Relapse, Week 4 0 0
Prior Relapse, Week 8 0 0
Prior Relapse, Week 12 1.2 0
Total, Week 2 0 0
Total, Week 4 3.7 2.6
Total, Week 8 3.7 5.3
Total, Week 12 9.8 5.3
6.Secondary Outcome
Title Percentage of Participants With On Treatment Virologic Failure
Hide Description On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA >1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.
Time Frame Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48
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Hide Analysis Population Description
FA Set.
Arm/Group Title Group A - Black Group B – Non-Black
Hide Arm/Group Description:
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Overall Number of Participants Analyzed 82 38
Measure Type: Number
Unit of Measure: percentage of participants
Prior Null Response, Week 2 0 0
Prior Null Response, Week 4 4.9 2.6
Prior Null Response, Week 8 8.5 7.9
Prior Null Response, Week 12 12.2 7.9
Prior Null Response, Week 16 19.5 7.9
Prior Null Response, Week 24 23.2 10.5
Prior Null Response, Week 28 23.2 13.2
Prior Null Response, Week 36 25.6 13.2
Prior Null Response, Week 40 28.0 13.2
Prior Null Response, Week 48 29.3 13.2
Prior Partial Response, Week 2 0 0
Prior Partial Response, Week 4 2.4 0
Prior Partial Response, Week 8 2.4 0
Prior Partial Response, Week 12 4.9 0
Prior Partial Response, Week 16 4.9 2.6
Prior Partial Response, Week 24 6.1 7.9
Prior Partial Response, Week 28 6.1 10.5
Prior Partial Response, Week 36 7.3 10.5
Prior Partial Response, Week 40 7.3 10.5
Prior Partial Response, Week 48 7.3 10.5
Prior Relapse, Week 2 0 0
Prior Relapse, Week 4 0 0
Prior Relapse, Week 8 0 0
Prior Relapse, Week 12 1.2 0
Prior Relapse, Week 16 1.2 0
Prior Relapse, Week 24 1.2 2.6
Prior Relapse, Week 28 1.2 2.6
Prior Relapse, Week 36 1.2 2.6
Prior Relapse, Week 40 1.2 5.3
Prior Relapse, Week 48 1.2 5.3
Total, Week 2 0 0
Total, Week 4 7.3 2.6
Total, Week 8 11.0 7.9
Total, Week 12 18.3 7.9
Total, Week 16 25.6 10.5
Total, Week 24 30.5 21.1
Total, Week 28 30.5 26.3
Total, Week 36 34.1 26.3
Total, Week 40 36.6 28.9
Total, Week 48 37.8 28.9
7.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
Time Frame Up to Week 52
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Safety Set.
Arm/Group Title Group A - Black Group B – Non-Black
Hide Arm/Group Description:
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Overall Number of Participants Analyzed 82 38
Measure Type: Number
Unit of Measure: percentage of participants
AE 96.3 100.0
SAE 8.5 15.8
8.Secondary Outcome
Title Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
Hide Description Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.
Time Frame up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set.
Arm/Group Title All Participants
Hide Arm/Group Description:
All enrolled participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: participants
47
9.Other Pre-specified Outcome
Title Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)
Hide Description [Not Specified]
Time Frame 48 weeks
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Hide Analysis Population Description
Pharmacokinetic sampling was not performed as per changes in planned analysis (protocol amendment); hence no data was collected.
Arm/Group Title Group A - Black Group B – Non-Black
Hide Arm/Group Description:
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to Week 52
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A - Black Group B – Non-Black
Hide Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
All-Cause Mortality
Group A - Black Group B – Non-Black
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group A - Black Group B – Non-Black
Affected / at Risk (%) Affected / at Risk (%)
Total   7/82 (8.54%)   6/38 (15.79%) 
Blood and lymphatic system disorders     
Anaemia  1  0/82 (0.00%)  2/38 (5.26%) 
Warm type haemolytic anaemia  1  1/82 (1.22%)  0/38 (0.00%) 
Cardiac disorders     
Angina pectoris  1  0/82 (0.00%)  1/38 (2.63%) 
Gastrointestinal disorders     
Abdominal pain  1  1/82 (1.22%)  0/38 (0.00%) 
Pancreatitis  1  0/82 (0.00%)  1/38 (2.63%) 
Vomiting  1  1/82 (1.22%)  0/38 (0.00%) 
General disorders     
Fatigue  1  1/82 (1.22%)  0/38 (0.00%) 
Infections and infestations     
Cellulitis  1  1/82 (1.22%)  0/38 (0.00%) 
Salmonellosis  1  1/82 (1.22%)  0/38 (0.00%) 
Urinary tract infection  1  1/82 (1.22%)  0/38 (0.00%) 
Injury, poisoning and procedural complications     
Facial bones fracture  1  0/82 (0.00%)  1/38 (2.63%) 
Hand fracture  1  0/82 (0.00%)  1/38 (2.63%) 
Laceration  1  0/82 (0.00%)  1/38 (2.63%) 
Metabolism and nutrition disorders     
Dehydration  1  1/82 (1.22%)  1/38 (2.63%) 
Hypokalaemia  1  1/82 (1.22%)  0/38 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  0/82 (0.00%)  1/38 (2.63%) 
Nervous system disorders     
Headache  1  1/82 (1.22%)  0/38 (0.00%) 
Psychiatric disorders     
Insomnia  1  0/82 (0.00%)  1/38 (2.63%) 
Suicidal ideation  1  0/82 (0.00%)  1/38 (2.63%) 
Renal and urinary disorders     
Renal failure acute  1  1/82 (1.22%)  0/38 (0.00%) 
Vascular disorders     
Accelerated hypertension  1  1/82 (1.22%)  0/38 (0.00%) 
Hypotension  1  0/82 (0.00%)  1/38 (2.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A - Black Group B – Non-Black
Affected / at Risk (%) Affected / at Risk (%)
Total   79/82 (96.34%)   38/38 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  40/82 (48.78%)  19/38 (50.00%) 
Neutropenia  1  9/82 (10.98%)  2/38 (5.26%) 
Thrombocytopenia  1  1/82 (1.22%)  2/38 (5.26%) 
Lymphopenia  1  0/82 (0.00%)  2/38 (5.26%) 
Iron deficiency anaemia  1  1/82 (1.22%)  0/38 (0.00%) 
Leukopenia  1  0/82 (0.00%)  1/38 (2.63%) 
Lymphadenopathy  1  0/82 (0.00%)  1/38 (2.63%) 
Cardiac disorders     
Palpitations  1  1/82 (1.22%)  2/38 (5.26%) 
Angina pectoris  1  1/82 (1.22%)  1/38 (2.63%) 
Coronary artery disease  1  1/82 (1.22%)  0/38 (0.00%) 
Left ventricular hypertrophy  1  1/82 (1.22%)  0/38 (0.00%) 
Ventricular extrasystoles  1  0/82 (0.00%)  1/38 (2.63%) 
Congenital, familial and genetic disorders     
Haemorrhagic arteriovenous malformation  1  1/82 (1.22%)  0/38 (0.00%) 
Ear and labyrinth disorders     
Ear pain  1  2/82 (2.44%)  1/38 (2.63%) 
Tinnitus  1  0/82 (0.00%)  2/38 (5.26%) 
Endocrine disorders     
Hyperthyroidism  1  1/82 (1.22%)  0/38 (0.00%) 
Eye disorders     
Vision blurred  1  2/82 (2.44%)  3/38 (7.89%) 
Abnormal sensation in eye  1  1/82 (1.22%)  1/38 (2.63%) 
Eye pain  1  1/82 (1.22%)  1/38 (2.63%) 
Vitreous floaters  1  2/82 (2.44%)  0/38 (0.00%) 
Conjunctival haemorrhage  1  1/82 (1.22%)  0/38 (0.00%) 
Dry eye  1  1/82 (1.22%)  0/38 (0.00%) 
Eye pruritus  1  1/82 (1.22%)  0/38 (0.00%) 
Photophobia  1  1/82 (1.22%)  0/38 (0.00%) 
Gastrointestinal disorders     
Nausea  1  20/82 (24.39%)  17/38 (44.74%) 
Anal pruritus  1  16/82 (19.51%)  5/38 (13.16%) 
Diarrhoea  1  7/82 (8.54%)  7/38 (18.42%) 
Haemorrhoids  1  8/82 (9.76%)  5/38 (13.16%) 
Anorectal discomfort  1  8/82 (9.76%)  4/38 (10.53%) 
Abdominal pain  1  4/82 (4.88%)  3/38 (7.89%) 
Vomiting  1  3/82 (3.66%)  4/38 (10.53%) 
Dyspepsia  1  2/82 (2.44%)  3/38 (7.89%) 
Abdominal pain upper  1  3/82 (3.66%)  1/38 (2.63%) 
Constipation  1  0/82 (0.00%)  4/38 (10.53%) 
Mouth ulceration  1  2/82 (2.44%)  2/38 (5.26%) 
Abdominal discomfort  1  3/82 (3.66%)  0/38 (0.00%) 
Abdominal pain lower  1  3/82 (3.66%)  0/38 (0.00%) 
Faeces discoloured  1  1/82 (1.22%)  2/38 (5.26%) 
Gastrooesophageal reflux disease  1  0/82 (0.00%)  3/38 (7.89%) 
Haematochezia  1  2/82 (2.44%)  1/38 (2.63%) 
Proctalgia  1  1/82 (1.22%)  2/38 (5.26%) 
Cheilitis  1  2/82 (2.44%)  0/38 (0.00%) 
Dry mouth  1  1/82 (1.22%)  1/38 (2.63%) 
Gingival pain  1  1/82 (1.22%)  1/38 (2.63%) 
Haemorrhoidal haemorrhage  1  0/82 (0.00%)  2/38 (5.26%) 
Tongue discolouration  1  2/82 (2.44%)  0/38 (0.00%) 
Abdominal distension  1  1/82 (1.22%)  0/38 (0.00%) 
Anal fissure  1  1/82 (1.22%)  0/38 (0.00%) 
Aphthous stomatitis  1  0/82 (0.00%)  1/38 (2.63%) 
Dental caries  1  0/82 (0.00%)  1/38 (2.63%) 
Eructation  1  1/82 (1.22%)  0/38 (0.00%) 
Frequent bowel movements  1  1/82 (1.22%)  0/38 (0.00%) 
Inguinal hernia  1  0/82 (0.00%)  1/38 (2.63%) 
Oesophageal spasm  1  0/82 (0.00%)  1/38 (2.63%) 
Oral lichen planus  1  1/82 (1.22%)  0/38 (0.00%) 
Rectal haemorrhage  1  1/82 (1.22%)  0/38 (0.00%) 
Retching  1  0/82 (0.00%)  1/38 (2.63%) 
Stomatitis  1  0/82 (0.00%)  1/38 (2.63%) 
Toothache  1  1/82 (1.22%)  0/38 (0.00%) 
General disorders     
Fatigue  1  31/82 (37.80%)  26/38 (68.42%) 
Influenza like illness  1  15/82 (18.29%)  7/38 (18.42%) 
Injection site erythema  1  9/82 (10.98%)  4/38 (10.53%) 
Chills  1  8/82 (9.76%)  4/38 (10.53%) 
Pyrexia  1  5/82 (6.10%)  3/38 (7.89%) 
Injection site rash  1  4/82 (4.88%)  2/38 (5.26%) 
Asthenia  1  2/82 (2.44%)  3/38 (7.89%) 
Malaise  1  2/82 (2.44%)  1/38 (2.63%) 
Oedema peripheral  1  2/82 (2.44%)  1/38 (2.63%) 
Pain  1  0/82 (0.00%)  3/38 (7.89%) 
Chest pain  1  2/82 (2.44%)  0/38 (0.00%) 
Adverse drug reaction  1  1/82 (1.22%)  0/38 (0.00%) 
Chest discomfort  1  1/82 (1.22%)  0/38 (0.00%) 
Crying  1  1/82 (1.22%)  0/38 (0.00%) 
Feeling abnormal  1  0/82 (0.00%)  1/38 (2.63%) 
Feeling jittery  1  0/82 (0.00%)  1/38 (2.63%) 
Injection site bruising  1  0/82 (0.00%)  1/38 (2.63%) 
Injection site discolouration  1  1/82 (1.22%)  0/38 (0.00%) 
Injection site discomfort  1  1/82 (1.22%)  0/38 (0.00%) 
Injection site reaction  1  0/82 (0.00%)  1/38 (2.63%) 
Local swelling  1  0/82 (0.00%)  1/38 (2.63%) 
Non-cardiac chest pain  1  1/82 (1.22%)  0/38 (0.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  1/82 (1.22%)  1/38 (2.63%) 
Infections and infestations     
Sinusitis  1  4/82 (4.88%)  1/38 (2.63%) 
Cellulitis  1  3/82 (3.66%)  1/38 (2.63%) 
Candida infection  1  3/82 (3.66%)  0/38 (0.00%) 
Conjunctivitis  1  0/82 (0.00%)  2/38 (5.26%) 
Herpes zoster  1  1/82 (1.22%)  1/38 (2.63%) 
Hordeolum  1  2/82 (2.44%)  0/38 (0.00%) 
Influenza  1  1/82 (1.22%)  1/38 (2.63%) 
Subcutaneous abscess  1  2/82 (2.44%)  0/38 (0.00%) 
Urinary tract infection  1  2/82 (2.44%)  0/38 (0.00%) 
Carbuncle  1  0/82 (0.00%)  1/38 (2.63%) 
Ear infection  1  1/82 (1.22%)  0/38 (0.00%) 
Fungal skin infection  1  1/82 (1.22%)  0/38 (0.00%) 
Furuncle  1  1/82 (1.22%)  0/38 (0.00%) 
Helicobacter gastritis  1  1/82 (1.22%)  0/38 (0.00%) 
Herpes simplex  1  1/82 (1.22%)  0/38 (0.00%) 
Localised infection  1  1/82 (1.22%)  0/38 (0.00%) 
Nasopharyngitis  1  1/82 (1.22%)  0/38 (0.00%) 
Oral candidiasis  1  1/82 (1.22%)  0/38 (0.00%) 
Otitis externa  1  1/82 (1.22%)  0/38 (0.00%) 
Pneumonia  1  1/82 (1.22%)  0/38 (0.00%) 
Staphylococcal abscess  1  1/82 (1.22%)  0/38 (0.00%) 
Tinea cruris  1  0/82 (0.00%)  1/38 (2.63%) 
Tinea infection  1  0/82 (0.00%)  1/38 (2.63%) 
Upper respiratory tract infection  1  0/82 (0.00%)  1/38 (2.63%) 
Vulvovaginal candidiasis  1  1/82 (1.22%)  0/38 (0.00%) 
Vulvovaginal mycotic infection  1  1/82 (1.22%)  0/38 (0.00%) 
Injury, poisoning and procedural complications     
Muscle strain  1  1/82 (1.22%)  2/38 (5.26%) 
Ankle fracture  1  1/82 (1.22%)  0/38 (0.00%) 
Arthropod bite  1  1/82 (1.22%)  0/38 (0.00%) 
Laceration  1  1/82 (1.22%)  0/38 (0.00%) 
Thermal burn  1  1/82 (1.22%)  0/38 (0.00%) 
Tooth fracture  1  1/82 (1.22%)  0/38 (0.00%) 
Upper limb fracture  1  1/82 (1.22%)  0/38 (0.00%) 
Investigations     
Weight decreased  1  2/82 (2.44%)  2/38 (5.26%) 
Blood creatinine increased  1  1/82 (1.22%)  1/38 (2.63%) 
Cardiac murmur  1  1/82 (1.22%)  1/38 (2.63%) 
Platelet count decreased  1  2/82 (2.44%)  0/38 (0.00%) 
Amylase increased  1  1/82 (1.22%)  0/38 (0.00%) 
Blood thyroid stimulating hormone decreased  1  0/82 (0.00%)  1/38 (2.63%) 
Blood uric acid increased  1  1/82 (1.22%)  0/38 (0.00%) 
Blood urine present  1  1/82 (1.22%)  0/38 (0.00%) 
Haemoglobin decreased  1  1/82 (1.22%)  0/38 (0.00%) 
Hepatic enzyme increased  1  0/82 (0.00%)  1/38 (2.63%) 
Lipase increased  1  1/82 (1.22%)  0/38 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  11/82 (13.41%)  7/38 (18.42%) 
Hyperuricaemia  1  8/82 (9.76%)  3/38 (7.89%) 
Hypokalaemia  1  6/82 (7.32%)  1/38 (2.63%) 
Dehydration  1  2/82 (2.44%)  0/38 (0.00%) 
Gout  1  0/82 (0.00%)  1/38 (2.63%) 
Hyperglycaemia  1  0/82 (0.00%)  1/38 (2.63%) 
Hypoglycaemia  1  0/82 (0.00%)  1/38 (2.63%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  10/82 (12.20%)  4/38 (10.53%) 
Arthralgia  1  3/82 (3.66%)  7/38 (18.42%) 
Pain in extremity  1  8/82 (9.76%)  1/38 (2.63%) 
Myalgia  1  5/82 (6.10%)  3/38 (7.89%) 
Muscle spasms  1  4/82 (4.88%)  2/38 (5.26%) 
Neck pain  1  3/82 (3.66%)  1/38 (2.63%) 
Flank pain  1  2/82 (2.44%)  0/38 (0.00%) 
Dupuytren's contracture  1  1/82 (1.22%)  0/38 (0.00%) 
Groin pain  1  0/82 (0.00%)  1/38 (2.63%) 
Joint range of motion decreased  1  1/82 (1.22%)  0/38 (0.00%) 
Joint stiffness  1  0/82 (0.00%)  1/38 (2.63%) 
Muscular weakness  1  1/82 (1.22%)  0/38 (0.00%) 
Musculoskeletal discomfort  1  1/82 (1.22%)  0/38 (0.00%) 
Musculoskeletal pain  1  1/82 (1.22%)  0/38 (0.00%) 
Musculoskeletal stiffness  1  1/82 (1.22%)  0/38 (0.00%) 
Pain in jaw  1  1/82 (1.22%)  0/38 (0.00%) 
Spinal osteoarthritis  1  0/82 (0.00%)  1/38 (2.63%) 
Vertebral foraminal stenosis  1  0/82 (0.00%)  1/38 (2.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Invasive ductal breast carcinoma  1  1/82 (1.22%)  0/38 (0.00%) 
Lipoma  1  1/82 (1.22%)  0/38 (0.00%) 
Skin papilloma  1  1/82 (1.22%)  0/38 (0.00%) 
Transitional cell cancer of the renal pelvis and ureter  1  1/82 (1.22%)  0/38 (0.00%) 
Uterine leiomyoma  1  1/82 (1.22%)  0/38 (0.00%) 
Nervous system disorders     
Headache  1  14/82 (17.07%)  13/38 (34.21%) 
Dizziness  1  7/82 (8.54%)  8/38 (21.05%) 
Dysgeusia  1  4/82 (4.88%)  3/38 (7.89%) 
Disturbance in attention  1  2/82 (2.44%)  2/38 (5.26%) 
Hypoaesthesia  1  3/82 (3.66%)  1/38 (2.63%) 
Paraesthesia  1  3/82 (3.66%)  0/38 (0.00%) 
Burning sensation  1  1/82 (1.22%)  0/38 (0.00%) 
Lethargy  1  0/82 (0.00%)  1/38 (2.63%) 
Neuropathy peripheral  1  1/82 (1.22%)  0/38 (0.00%) 
Presyncope  1  0/82 (0.00%)  1/38 (2.63%) 
Sinus headache  1  1/82 (1.22%)  0/38 (0.00%) 
Syncope  1  1/82 (1.22%)  0/38 (0.00%) 
Tension headache  1  0/82 (0.00%)  1/38 (2.63%) 
Tremor  1  0/82 (0.00%)  1/38 (2.63%) 
Psychiatric disorders     
Insomnia  1  8/82 (9.76%)  10/38 (26.32%) 
Depression  1  8/82 (9.76%)  4/38 (10.53%) 
Irritability  1  6/82 (7.32%)  4/38 (10.53%) 
Anxiety  1  4/82 (4.88%)  2/38 (5.26%) 
Sleep disorder  1  1/82 (1.22%)  3/38 (7.89%) 
Mood swings  1  1/82 (1.22%)  1/38 (2.63%) 
Alcoholism  1  0/82 (0.00%)  1/38 (2.63%) 
Confusional state  1  1/82 (1.22%)  0/38 (0.00%) 
Hallucination  1  0/82 (0.00%)  1/38 (2.63%) 
Initial insomnia  1  0/82 (0.00%)  1/38 (2.63%) 
Panic attack  1  0/82 (0.00%)  1/38 (2.63%) 
Restlessness  1  0/82 (0.00%)  1/38 (2.63%) 
Stress  1  1/82 (1.22%)  0/38 (0.00%) 
Renal and urinary disorders     
Haematuria  1  2/82 (2.44%)  0/38 (0.00%) 
Dysuria  1  1/82 (1.22%)  0/38 (0.00%) 
Nephrolithiasis  1  1/82 (1.22%)  0/38 (0.00%) 
Renal failure  1  0/82 (0.00%)  1/38 (2.63%) 
Renal pain  1  0/82 (0.00%)  1/38 (2.63%) 
Reproductive system and breast disorders     
Erectile dysfunction  1  3/82 (3.66%)  1/38 (2.63%) 
Dyspareunia  1  1/82 (1.22%)  0/38 (0.00%) 
Genital rash  1  1/82 (1.22%)  0/38 (0.00%) 
Penile discharge  1  1/82 (1.22%)  0/38 (0.00%) 
Penis disorder  1  1/82 (1.22%)  0/38 (0.00%) 
Vaginal haemorrhage  1  1/82 (1.22%)  0/38 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  11/82 (13.41%)  4/38 (10.53%) 
Cough  1  7/82 (8.54%)  1/38 (2.63%) 
Dyspnoea exertional  1  2/82 (2.44%)  0/38 (0.00%) 
Oropharyngeal pain  1  1/82 (1.22%)  1/38 (2.63%) 
Sinus congestion  1  2/82 (2.44%)  0/38 (0.00%) 
Epistaxis  1  0/82 (0.00%)  1/38 (2.63%) 
Increased upper airway secretion  1  0/82 (0.00%)  1/38 (2.63%) 
Nasal congestion  1  0/82 (0.00%)  1/38 (2.63%) 
Nasal mucosal disorder  1  1/82 (1.22%)  0/38 (0.00%) 
Productive cough  1  1/82 (1.22%)  0/38 (0.00%) 
Upper-airway cough syndrome  1  1/82 (1.22%)  0/38 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  33/82 (40.24%)  16/38 (42.11%) 
Rash  1  15/82 (18.29%)  13/38 (34.21%) 
Alopecia  1  6/82 (7.32%)  2/38 (5.26%) 
Dry skin  1  6/82 (7.32%)  2/38 (5.26%) 
Drug eruption  1  5/82 (6.10%)  1/38 (2.63%) 
Pruritus generalised  1  5/82 (6.10%)  1/38 (2.63%) 
Skin discolouration  1  2/82 (2.44%)  0/38 (0.00%) 
Skin fissures  1  2/82 (2.44%)  0/38 (0.00%) 
Dermatitis  1  1/82 (1.22%)  0/38 (0.00%) 
Dermatitis atopic  1  0/82 (0.00%)  1/38 (2.63%) 
Drug reaction with eosinophilia and systemic symptoms  1  0/82 (0.00%)  1/38 (2.63%) 
Erythema  1  0/82 (0.00%)  1/38 (2.63%) 
Hyperhidrosis  1  0/82 (0.00%)  1/38 (2.63%) 
Ingrowing nail  1  0/82 (0.00%)  1/38 (2.63%) 
Lichen planus  1  1/82 (1.22%)  0/38 (0.00%) 
Neurodermatitis  1  1/82 (1.22%)  0/38 (0.00%) 
Photosensitivity reaction  1  0/82 (0.00%)  1/38 (2.63%) 
Pigmentation disorder  1  1/82 (1.22%)  0/38 (0.00%) 
Psoriasis  1  1/82 (1.22%)  0/38 (0.00%) 
Rash maculo-papular  1  1/82 (1.22%)  0/38 (0.00%) 
Rash papular  1  0/82 (0.00%)  1/38 (2.63%) 
Rash pruritic  1  1/82 (1.22%)  0/38 (0.00%) 
Rosacea  1  0/82 (0.00%)  1/38 (2.63%) 
Skin hyperpigmentation  1  1/82 (1.22%)  0/38 (0.00%) 
Urticaria  1  0/82 (0.00%)  1/38 (2.63%) 
Vascular disorders     
Hypertension  1  4/82 (4.88%)  0/38 (0.00%) 
Flushing  1  0/82 (0.00%)  1/38 (2.63%) 
Orthostatic hypotension  1  1/82 (1.22%)  0/38 (0.00%) 
Pallor  1  0/82 (0.00%)  1/38 (2.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
It was decided by Sponsor on 13 January 2014 to terminate the study early as part of a decision to modify the drug development plan. Eligible participants completed virologic follow-up after termination.
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.
PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Monitor
Organization: Vertex Pharmaceuticals Incorporated
Phone: 617-341-6777
EMail: medicalinfo@vrtx.com
Layout table for additonal information
Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01467492     History of Changes
Other Study ID Numbers: VX11-950-116
First Submitted: November 3, 2011
First Posted: November 8, 2011
Results First Submitted: June 1, 2015
Results First Posted: June 16, 2015
Last Update Posted: August 3, 2015