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Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation

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ClinicalTrials.gov Identifier: NCT00447902
Recruitment Status : Terminated
First Posted : March 15, 2007
Results First Posted : December 23, 2009
Last Update Posted : May 14, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: tipranavir
Drug: ritonavir
Enrollment 11
Recruitment Details With FDA and EMEA agreement, the trial was prematurely discontinued before reaching the target number of patients to be entered due to poor recruitment. For this reason analyzing and reporting data as planned for primary and secondary endpoints have not been performed. No objectives were reached and no conclusion can be drawn from this study.
Pre-assignment Details One patient has been randomised by mistake in Brasil and so he was not treated
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Period Title: Overall Study
Started 5 6
Completed 1 0
Not Completed 4 6
Reason Not Completed
Adverse Event             0             3
Protocol Violation             1             0
Withdrawal by Subject             0             1
included patients who discontinued             1             1
Lack of Efficacy             2             1
Arm/Group Title Standard of Care Therapeutic Drug Monitoring Total
Hide Arm/Group Description Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules Total of all reporting groups
Overall Number of Baseline Participants 4 6 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 6 participants 10 participants
46.00  (2.90) 45.20  (5.40) 45.50  (4.40)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 10 participants
Female
1
  25.0%
1
  16.7%
2
  20.0%
Male
3
  75.0%
5
  83.3%
8
  80.0%
[1]
Measure Description: Included patients who discontinued due to early termination
1.Primary Outcome
Title Treatment Response at Week 48
Hide Description Treatment response is a confirmed virologic response, defined as a viral load less than 50 copies/mL at two consecutive measurements at least 5 days apart, without death, permanent discontinuation, or introduction of a new antiretroviral
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title The Primary Safety Endpoint Was the Occurrence of Dose-limiting Hepatotoxicity During the Study.
Hide Description Dose-limiting hepatotoxicity was defined as Grade 4 ALT or AST elevation confirmed in 48h or any evocative symptoms or signs of hepatitis, if it not clearly attributable to another cause. Patients who experienced dose-limiting hepatotoxicity stopped TPV/r and were considered treatment failures for the analysis.
Time Frame From the start of the study through 48 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Virologic Response Defined as Viral Load <50 Copies/mL at Each Visit
Hide Description Virologic response defined as viral load less than 50 copies/mL
Time Frame After 4 weeks of treatment until the end of the trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Occurrence of Viral Load Less Than 400 Copies/mL at Weeks 24 and 48
Hide Description Patients with a viral load of less than 400 copies/mL at Weeks 24 and 48 as measured from a plasma sample.
Time Frame 24 and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Occurrence of Viral Load Less Than 400 Copies/mL at Each Visit
Hide Description Patients with a viral load of less than 400 copies/mL at each visit as measured from a plasma sample.
Time Frame After 4 weeks of treatment until the end of the trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Occurrence of ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48
Hide Description Occurrence of greater than or equal to 1 log10 drop in viral load from baseline at all visits, including visits at Weeks 24 and 48
Time Frame Baseline, 24 and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change in Viral Load From Baseline at Each Visit
Hide Description Change in viral load (measured from a plasma sample) from baseline at each visitPatients with a viral load of less than 400 copies/mL at each visit as .
Time Frame After 4 weeks of treatment until the end of the trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Time to Treatment Failure
Hide Description For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.
Time Frame After Day 1 of treatment until the end of the trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Time to New AIDS or AIDS Related Progression Event or Death
Hide Description Time to new AIDS or AIDS related progression event or death as defined by AIDS defining and/or AIDS-related illnesses.
Time Frame After Day 1 of treatment until the end of the trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change in CD4+ and CD8+ Cell Counts From Baseline to Week 48
Hide Description Change from baseline to Week 48 for CD4+ and CD8+ cell counts. Samples were obtained for CD4+ and CD8+ as measurements of viral suppression during antiretroviral therapy.
Time Frame after 2 weeks of treatment till Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change in Ratio of CD38+/CD8+ From Baseline to Week 48
Hide Description Change from baseline to Week 48 for the ratio of CD38+ to CD8+ cell counts. Samples were obtained for CD38+ and CD8+ as measurements of viral suppression during antiretroviral therapy.
Time Frame after 2 weeks of treatment till Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48.
Hide Description Change from baseline to Week 48 for the ratio of CD3+ CD8+ CD38+ HLA DR . Samples were obtained for CD3+ CD8+ CD38+ HLA DR as measurements of viral suppression during antiretroviral therapy.
Time Frame after 2 weeks of treatment till Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Hide Description Tipranavir (TPV) and Ritonavir (RTV) trough concentrations from plasma samples at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Time Frame after 2 weeks of treatment till Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Patients Adherence With Study Medication Based on Pill Count
Hide Description number of pills actually taken divided by the planned number of pills the patient should take
Time Frame After 4 weeks of treatment until the end of the trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Occurrence of Tipranavir (TPV) Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured
Hide Description A high inhibitory quotient (IQ), the ratio of trough plasma drug concentration to the protein-adjusted viral IC50, is a useful indicator of the potential efficacy margin of antiretroviral drugs. The IQ for TPV is calculated by the formula IQ = TPV Ctrough / (3.75 x Z x fold change of the patients virus), where Z = wild type control IC50 IIIB.
Time Frame After 2 weeks of treatment until the end of trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Occurrence of Tipranavir (TPV) Trough Concentration >120 μM
Hide Description Patients with TPV trough above 120 μM are at high risk of developing a Grade 3 or 4 ALT or AST elevations. The risk of Grade 3 or greater transaminase elevations appeared to be uniform at TPV trough concentration below 120 μM. Hence, for this study the TPV trough should be maintained below 120 μM.
Time Frame After 2 weeks of treatment until the end of trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Post-dose Tipranavir (TPV) and Ritonavir (RTV) Concentrations at Week 4
Hide Description Post-dose Tipranavir (TPV) and Ritonavir (RTV) plasma concentrations at Week 4
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial has been stopped due to a poor enrollment
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Frequency of Patients (%) With Possible Clinically Significant Abnormalities of Laboratory Measurements
Hide Description Frequency of patients (%) with possible clinically significant abnormalities of laboratory measurements (haematology, differentials (automatic and absolute), coagulation, electrolytes, enzymes, substrates, urinalysis, serology and T-cells)
Time Frame Baseline through 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description:
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Overall Number of Participants Analyzed 4 6
Measure Type: Number
Unit of Measure: percentage of participants
Hematocrit - decrease 25.0 16.7
Red Blood Cell count - decrease 25.0 0
Prothrombin time - increase 0 20
AST/GOT, SGOT - increase 50.0 33.3
ALT/GPT, SGPT - increase 25.0 33.3
Lipase - increase 0 16.7
Bilirubin, total - increase 0 16.7
Bilirubin, direct - increase 0 16.7
Triglyceride - increase 0 25
Time Frame Screening through the duration of the trial (Week 48 planned).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard of Care Therapeutic Drug Monitoring
Hide Arm/Group Description Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
All-Cause Mortality
Standard of Care Therapeutic Drug Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard of Care Therapeutic Drug Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   2/6 (33.33%) 
Cardiac disorders     
cardio respiratory arrest  1  0/4 (0.00%)  1/6 (16.67%) 
Gastrointestinal disorders     
abdominal pain  1  0/4 (0.00%)  1/6 (16.67%) 
abdominal pain upper  1  0/4 (0.00%)  1/6 (16.67%) 
diarrhoea  1  0/4 (0.00%)  1/6 (16.67%) 
faeces discoloured  1  0/4 (0.00%)  1/6 (16.67%) 
vomiting  1  0/4 (0.00%)  1/6 (16.67%) 
General disorders     
pyrexia  1  1/4 (25.00%)  0/6 (0.00%) 
Hepatobiliary disorders     
cholelithiasis  1  0/4 (0.00%)  1/6 (16.67%) 
Investigations     
aspartate aminotransferase increased  1  0/4 (0.00%)  1/6 (16.67%) 
alanine aminotransferase increased  2  0/4 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 11.1 WHO-DD
2
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard of Care Therapeutic Drug Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   3/4 (75.00%)   2/6 (33.33%) 
Cardiac disorders     
palpitations  1  0/4 (0.00%)  1/6 (16.67%) 
Ear and labyrinth disorders     
vertigo  1  0/4 (0.00%)  1/6 (16.67%) 
Gastrointestinal disorders     
abdominal pain  1  1/4 (25.00%)  0/6 (0.00%) 
dysphagia  1  1/4 (25.00%)  0/6 (0.00%) 
General disorders     
adverse drug reaction  1  2/4 (50.00%)  0/6 (0.00%) 
pyrexia  1  1/4 (25.00%)  0/6 (0.00%) 
fatigue  1  1/4 (25.00%)  0/6 (0.00%) 
injection site nodule  1  1/4 (25.00%)  0/6 (0.00%) 
nodule  1  1/4 (25.00%)  0/6 (0.00%) 
Infections and infestations     
oral candidiasis  1  1/4 (25.00%)  0/6 (0.00%) 
sinusitis  1  1/4 (25.00%)  0/6 (0.00%) 
Investigations     
alanine aminotransferase increased  1  0/4 (0.00%)  1/6 (16.67%) 
blood albumin decreased  1  1/4 (25.00%)  0/6 (0.00%) 
haemoglobin decrease  1  1/4 (25.00%)  0/6 (0.00%) 
aspartate aminotransferase increased  1  0/4 (0.00%)  1/6 (16.67%) 
Metabolism and nutrition disorders     
hypertriglyceridaemia  1  1/4 (25.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders     
back pain  1  1/4 (25.00%)  0/6 (0.00%) 
muscle spasms  1  1/4 (25.00%)  0/6 (0.00%) 
musculoskeletal pain  1  1/4 (25.00%)  0/6 (0.00%) 
Nervous system disorders     
dizziness  1  0/4 (0.00%)  1/6 (16.67%) 
headache  1  0/4 (0.00%)  1/6 (16.67%) 
paraesthesia  1  0/4 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders     
erythema  1  0/4 (0.00%)  1/6 (16.67%) 
Skin nodules  1  1/4 (25.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 11.1 WHO-DD
Due to an early termination of the trial no analysis has been performed for primary and secondary endpoints
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00447902     History of Changes
Other Study ID Numbers: 1182.99
EudraCT No.: 2005-005023-33
First Submitted: March 14, 2007
First Posted: March 15, 2007
Results First Submitted: September 25, 2009
Results First Posted: December 23, 2009
Last Update Posted: May 14, 2014