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Trial record 85 of 2130 for:    Hepatitis C

Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)

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ClinicalTrials.gov Identifier: NCT00892697
Recruitment Status : Completed
First Posted : May 4, 2009
Results First Posted : March 20, 2015
Last Update Posted : March 20, 2015
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Telaprevir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telaprevir/Peg-IFN/RBV
Hide Arm/Group Description

15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.

Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg).

Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Telaprevir/Peg-IFN/RBV
Hide Arm/Group Description

15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.

Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg).

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 15 participants
50
(46.5 to 58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
5
  33.3%
Male
10
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Intrahepatic and Plasma HCV Viral Kinetics
Hide Description Intrahepatic viral kinetics, plasma viral kinetics,
Time Frame Day-7, Day 1, Day 4,
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telaprevir/Peg-IFN/RBV
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15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.

Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy.

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: log transformed copies/ml
Plasma HCV RNA predose 6.5  (0.8)
Plasma HCV RNA 10 hrs 4.9  (0.9)
Plasma HCV RNA day 4 3.2  (0.6)
Liver HCV RNA predose 4.2  (1.2)
Liver HCV RNA 10 hrs 4.0  (1.3)
Liver HCV RNA day 4 3.9  (1.2)
2.Secondary Outcome
Title Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir
Hide Description Intrahepatic and plasma telaprevir concentration ratios
Time Frame Day 1, Day 4, Day 15, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telaprevir/PEG-IFN/RBV
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15 subjects will receive Telaprevir in combination with pegylated interferon alfa-2a and ribavirin
Overall Number of Participants Analyzed 15
Median (Inter-Quartile Range)
Unit of Measure: telaprevir liver to plasma conc ratio
telaprevir liver/plasma conc ratio day 1
0.72
(0.4 to 1.01)
telaprevir liver/plasma conc ratio day 4
0.47
(0.33 to 0.78)
telaprevir liver/plasma conc ratio day 15
0.57
(0.34 to 0.76)
telaprevir liver/plasma conc ratio week 8
0.61
(0.42 to 0.84)
Time Frame Participants were followed for up to 24 weeks post treatment cessation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telaprevir/PEG-IFN/RBV
Hide Arm/Group Description

15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.

Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy.

All-Cause Mortality
Telaprevir/PEG-IFN/RBV
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Telaprevir/PEG-IFN/RBV
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
Nervous system disorders   
Subarachnoid hemorrhage   1/15 (6.67%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Telaprevir/PEG-IFN/RBV
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
Nervous system disorders   
Subarachnoid hemorrhage   1/15 (6.67%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Andrew Talal, MD
Organization: University at Buffalo
Phone: 716-888-4737
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00892697     History of Changes
Other Study ID Numbers: 0810010040
First Submitted: April 30, 2009
First Posted: May 4, 2009
Results First Submitted: December 18, 2014
Results First Posted: March 20, 2015
Last Update Posted: March 20, 2015