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Trial record 17 of 28 for:    " January 24, 2007":" February 23, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.

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ClinicalTrials.gov Identifier: NCT00435929
Recruitment Status : Completed
First Posted : February 16, 2007
Results First Posted : January 8, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Ritonavir
Drug: saquinavir [Invirase]
Enrollment 16
Recruitment Details The study was conducted from 12 September 2006 to 09 April 2009 at 3 sites in US and 2 in Canada.
Pre-assignment Details Total 19 participants were screened. A total 9 participants with HIV infection with moderate liver disease (Group 2) and 7 participants with HIV infection with normal liver function (Group 1) were enrolled in the study. Participants in Group 1 were matched with those in Group 2 on the basis of age, gender, weight, and tobacco use.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days. Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Period Title: Overall Study
Started 7 9
Completed 7 9
Not Completed 0 0
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment Total
Hide Arm/Group Description Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days. Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days. Total of all reporting groups
Overall Number of Baseline Participants 7 9 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
9
 100.0%
16
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 16 participants
Female
2
  28.6%
3
  33.3%
5
  31.3%
Male
5
  71.4%
6
  66.7%
11
  68.8%
1.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV)
Hide Description Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the area under the plasma concentration-time curve from 0 to 12 hours after dosing (AUC (0-12h) of SQV and RTV The AUC (0-12hours) was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.
Time Frame Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description:
Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
AUC for SQV 28518  (20157) 24332  (24700)
AUC for RTV 10985  (1723) 9930  (5243)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Liver Function, Moderate Hepatic Impairment
Comments Comparison between normal liver function and moderate hepatic impairment for SQV
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.656
Confidence Interval (2-Sided) 90%
0.268 to 1.603
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Liver Function, Moderate Hepatic Impairment
Comments Comparison between normal liver function and moderate hepatic impairment for RTV.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.764
Confidence Interval (2-Sided) 90%
0.505 to 1.156
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of SQV and RTV
Hide Description The plasma concentration (Cmax) is defined as maximum observed analyte concentration. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the maximum observed plasma concentration (C max) of SQV and Ritonavir RTV The Cmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.
Time Frame Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description:
Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax of SQV 4300  (2940) 3610  (3000)
Cmax of RTV 1500  (294) 1460  (690)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Liver Function, Moderate Hepatic Impairment
Comments Comparison between normal liver function and moderate hepatic impairment for SQV.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.716
Confidence Interval (2-Sided) 90%
0.311 to 1.644
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Liver Function, Moderate Hepatic Impairment
Comments Comparison between normal liver function and moderate hepatic impairment for RTV.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.844
Confidence Interval (2-Sided) 90%
0.551 to 1.292
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time of Maximum Plasma Concentration (Tmax) of SQV and RTV
Hide Description The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the time of maximum plasma concentration of SQV and RTV. The Tmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.
Time Frame Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description:
Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: hour
Tmax of SQV 5.00  (1.83) 5.00  (2.38)
Tmax of RTV 4.29  (1.50) 4.07  (1.75)
4.Secondary Outcome
Title Terminal Half-life (T1/2) of SQV and RTV
Hide Description Terminal half-life is the time measured for the plasma concentration to decrease by one half. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the terminal half-life (T1/2) of SQV and RTV. The T1/2 was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.
Time Frame Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description:
Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: hour
T1/2 of SQV 3.31  (0.823) 4.10  (1.90)
T1/2 of RTV 3.80  (0.908) 4.82  (2.82)
5.Secondary Outcome
Title Minimum Observed Plasma Concentration (Cmin) of SQV and RTV
Hide Description Cmin is the minimum blood plasma concentration that a drug achieves. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the minimum observed plasma concentration (C min) of SQV and RTV The Cmin was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.
Time Frame Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description:
Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmin of SQV 965  (920) 834  (870)
Cmin of RTV 399  (172) 418  (300)
6.Secondary Outcome
Title Plasma Clearance After Oral Administration (CL/F) of SQV and RTV
Hide Description The CL/F is the oral clearance; that is clearance based on oral bioavailability. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the plasma clearance after oral administration (CL/F)of SQV and RTV The CL/F was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.
Time Frame Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description:
Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: L/hr
CL/F of SQV 47.052  (20.254) 84.416  (68.645)
CL/F of RTV 9.289  (1.392) 12.568  (5.885)
7.Secondary Outcome
Title Volume of Distribution (Vd) of SQV and RTV
Hide Description Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the Vd of SQV and RTV The Vd was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.
Time Frame Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description:
Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: Litres
Vd of SQV 213.294  (95.048) 464.049  (334.460)
Vd of RTV 50.232  (11.888) 102.585  (112.579)
8.Secondary Outcome
Title Cluster of Differentiation 4 (CD4 ) Count
Hide Description The pharmacodynamic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the cluster of differentiation 4 (CD4) count in participants in each group.
Time Frame Screening (Day -35 to -1), pre-dose on Day 8, Day 14 and at follow up (Day 28-Day 35)
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Hide Analysis Population Description
PD analysis population: All participants who received at least 1 dose of the study medication and had at least 1 pharmacodynamic (PD) measure were included in the PD analysis population.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description:
Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: cells/cubic millimeter
Screening; n=7, 9 540.000  (218.187) 451.444  (249.011)
Day 8;n=6, 9 638.500  (254.358) 558.000  (243.994)
Day 14;n=7, 9 683.571  (250.160) 566.333  (257.484)
Follow up; n=6, 8 692.500  (150.045) 567.625  (261.947)
9.Secondary Outcome
Title Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Parameters
Hide Description Laboratory parameters specified in Clinical Operating Guidelines (COG) were summarized. AIDS Clinical Trial Group (ACTG) and American Heart Association (AHA) criteria were used to grade COG laboratory test values. Laboratory parameters for which an increase to Grade 3 (G3) or Grade 4 (G4) occurred are presented in the table below.
Time Frame Up to Day 35
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description:
Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Overall Number of Participants Analyzed 7 9
Measure Type: Number
Unit of Measure: participants
ASAT (SGOT), (Hyper) G3 0 1
ASAT (SGOT), (Hyper) G4 0 0
Alkaline Phosphatase, (Hyper) G3 0 0
Alkaline Phosphatase, (Hyper) G4 0 0
ALAT (SGPT), (Hyper) G3 0 0
ALAT (SGPT), (Hyper) G4 0 0
Direct Bilirubin, (Hyper) G3 0 1
Direct Bilirubin, (Hyper) G4 0 1
Creatinine, (Hyper) G3 0 0
Creatinine, (Hyper) G4 0 0
Albumin, (Hypo) G3 0 0
Albumin, (Hypo) G4 0 0
Prothrombin Time seconds(Hyper) G3 0 1
Prothrombin Time seconds (Hyper) G4 0 0
Creatine Kinase, (Hyper) G3 0 1
Creatine Kinase, (Hyper) G4 0 0
Cholesterol, (Hyper) G3 0 0
Cholesterol, (Hyper) G4 0 0
Triglycerides, (Hyper) G3 2 0
Triglycerides, (Hyper) G4 0 0
Calcium, (Hypo) G3 0 0
Calcium, (Hypo) G4 0 0
Potassium, (Hypo) G3 0 0
Potassium, (Hypo) G4 0 0
Sodium, (Hypo) G3 0 0
Sodium, (Hypo) G4 0 0
Platelets, (Hypo) G3 0 0
Platelets, (Hypo) G4 0 0
Neutrophils, (Hypo) G3 0 1
Neutrophils, (Hypo) G4 0 0
Fasting Glucose, (Hyper) G3 0 0
Fasting Glucose, (Hyper) G4 0 0
Amylase, (Hyper) G3 0 1
Amylase, (Hyper) G4 0 0
Uric Acid, (Hyper) G3 0 2
Uric Acid, (Hyper) G4 0 0
Proteinuria 0 to 4+, (Hyper) G3 0 1
Proteinuria 0 to 4+, (Hyper) G4 0 0
10.Secondary Outcome
Title Number Participants With Abnormal Vital Signs
Hide Description Abnormal Vital signs included are high and low Pulse rate (PR), high and how Temperature (Temp), high and low Systolic Blood Pressure (SBP) and high and low Diastolic Blood Pressure (DBP). Vital signs (SBP, DBP, PR,Temp) were measured after participants were in a semi-supine position for at least 5 minutes.
Time Frame Up to Day 35
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description:
Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Overall Number of Participants Analyzed 7 9
Measure Type: Number
Unit of Measure: participants
High PR 0 0
Low PR 0 0
High Temp 0 0
Low Temp 0 0
High-SBP 1 1
Low-SBP 0 0
High-DBP 0 0
Low-DBP 1 2
11.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Hide Description Abnormal ECG findings included are high and low Heart Rate (HRT), high and low PQ/PR interval (PQ/PR), high and low QRS interval (QRS), high and low QT interval (QT), high and low QTCB interval (QTcB), high and low QTcF interval (QTcF), high and low RR interval (RR), high and low T Wave, high and low U Wave, high and low ECG. The 12 Lead ECG was recorded after participants were in a semi-supine position for at least 5 minutes. Only participants with abnormal ECG findings are presented in the table below.
Time Frame Up to Day 35
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description:
Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Overall Number of Participants Analyzed 7 9
Measure Type: Number
Unit of Measure: participants
HIGH- HRT ECG ; n=7, 9 1 0
LOW- HRT ECG; n=7, 9 0 0
HIGH- PQ (PR); n=7, 9 0 1
LOW- PQ (PR); n=7, 9 0 0
HIGH- QRS; n=7, 9 0 0
LOW- QRS; n=7, 9 0 0
HIGH- QT; n=7, 9 0 2
LOW- QT; n=7, 9 0 0
HIGH- QTcB; n=5, 8 0 2
LOW- QTcB; n=5, 8 0 0
HIGH- QTcF; n=5, 8 0 2
LOW- QTcF; n=5, 8 0 0
HIGH- RR; n=5, 8 0 0
LOW- RR; n=5, 8 1 0
HIGH- T WAVE; n=7, 9 0 0
LOW- T WAVE; n=7, 9 0 0
HIGH- U WAVE; n=1, 0 0 0
LOW- U WAVE; n=1, 0 0 0
HIGH- ECG; n=7, 9 0 0
LOW- ECG; n=7, 9 0 0
Time Frame Up to Day 35
Adverse Event Reporting Description All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety population. .All AE’s and SAE’s were collected following the first dose, as well as those that started prior to dosing and worsened on or after the first dose.
 
Arm/Group Title Normal Liver Function Moderate Hepatic Impairment
Hide Arm/Group Description Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days. Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
All-Cause Mortality
Normal Liver Function Moderate Hepatic Impairment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Normal Liver Function Moderate Hepatic Impairment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   1/9 (11.11%) 
Gastrointestinal disorders     
Upper gastrointestinal haemorrhage  1  0/7 (0.00%)  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Normal Liver Function Moderate Hepatic Impairment
Affected / at Risk (%) Affected / at Risk (%)
Total   3/7 (42.86%)   5/9 (55.56%) 
Gastrointestinal disorders     
Diarrhoea  1  3/7 (42.86%)  1/9 (11.11%) 
Nausea  1  1/7 (14.29%)  3/9 (33.33%) 
Abdominal discomfort  1  0/7 (0.00%)  2/9 (22.22%) 
Abdominal distension  1  0/7 (0.00%)  1/9 (11.11%) 
Dyspepsia  1  0/7 (0.00%)  1/9 (11.11%) 
Flatulence  1  0/7 (0.00%)  1/9 (11.11%) 
Vomiting  1  0/7 (0.00%)  1/9 (11.11%) 
General disorders     
Fatigue  1  0/7 (0.00%)  3/9 (33.33%) 
Oedema Peripheral  1  0/7 (0.00%)  1/9 (11.11%) 
Pain  1  0/7 (0.00%)  1/9 (11.11%) 
Hepatobiliary disorders     
Jaundice  1  0/7 (0.00%)  1/9 (11.11%) 
Liver Tenderness  1  0/7 (0.00%)  1/9 (11.11%) 
Infections and infestations     
Influenza  1  0/7 (0.00%)  1/9 (11.11%) 
Nasopharyngitis  1  1/7 (14.29%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  0/7 (0.00%)  1/9 (11.11%) 
Nervous system disorders     
Headache  1  0/7 (0.00%)  1/9 (11.11%) 
Renal and urinary disorders     
Micturition Urgency  1  1/7 (14.29%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Name/Title: F. Hoffmann-La Roche AG
Organization: Roche Trial Information Hotline
Phone: +41 61 6878333
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00435929     History of Changes
Other Study ID Numbers: BP17921
First Submitted: February 15, 2007
First Posted: February 16, 2007
Results First Submitted: December 2, 2015
Results First Posted: January 8, 2016
Last Update Posted: March 29, 2018