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Trial record 21 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients

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ClinicalTrials.gov Identifier: NCT01592006
Recruitment Status : Terminated (Low accrual)
First Posted : May 4, 2012
Results First Posted : January 12, 2015
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Peginterferon alfa-2a
Drug: Ribavirin
Drug: telaprevir
Enrollment 3
Recruitment Details Since new better drug options had became available, the intervention drug of this study was no longer the best option for the patients. Thus this study was terminated.
Pre-assignment Details  
Arm/Group Title HCV, LT, Pegasys, Ribavirin, Telaprevir
Hide Arm/Group Description Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title HCV, LT, Pegasys, Ribavirin, Telaprevir
Hide Arm/Group Description Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
56  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
0
   0.0%
Male
3
 100.0%
1.Primary Outcome
Title The Efficacy of Triple Antiviral Therapy
Hide Description To evaluate the efficacy of triple antiviral therapy, consisting of pegylated interferon alfa-2a (Pegasys®), ribavirin, and telaprevir therapy in liver transplant recipients with hepatitis C. This will be measured and reported by sustained virologic response (defined as undetectable HCV RNA in the blood 24 weeks after completing therapy [SVR24])
Time Frame 3 years from start of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HCV, LT, Pegasys, Ribavirin, Telaprevir
Hide Arm/Group Description:
Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: percentage of participants
100
2.Secondary Outcome
Title Safety of Triple Antiviral Therapy in HCV Infected OLT Recipients
Hide Description Tolerability and Safety will be measured and reported by serious adverse events.
Time Frame 6 years from the start of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HCV, LT, Pegasys, Ribavirin, Telaprevir
Hide Arm/Group Description:
Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
0
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HCV, LT, Pegasys, Ribavirin, Telaprevir
Hide Arm/Group Description Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
All-Cause Mortality
HCV, LT, Pegasys, Ribavirin, Telaprevir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HCV, LT, Pegasys, Ribavirin, Telaprevir
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HCV, LT, Pegasys, Ribavirin, Telaprevir
Affected / at Risk (%)
Total   3/3 (100.00%) 
Blood and lymphatic system disorders   
Anemia   2/3 (66.67%) 
Gastrointestinal disorders   
Anorectal discomfort   2/3 (66.67%) 
Nausea   1/3 (33.33%) 
Diarrhea   1/3 (33.33%) 
General disorders   
Fatigue   3/3 (100.00%) 
MVA   1/3 (33.33%) 
Mouth sores   1/3 (33.33%) 
Fever   1/3 (33.33%) 
Nervous system disorders   
Headache   2/3 (66.67%) 
Psychiatric disorders   
Irritable   2/3 (66.67%) 
Skin and subcutaneous tissue disorders   
Rash   2/3 (66.67%) 
Pruritus   1/3 (33.33%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Helen S. Te
Organization: University of Chicago Medical Center
Phone: 773-702-2395
EMail: hte@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01592006     History of Changes
Other Study ID Numbers: 12-0156
First Submitted: April 27, 2012
First Posted: May 4, 2012
Results First Submitted: January 5, 2015
Results First Posted: January 12, 2015
Last Update Posted: June 15, 2016