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Trial record 48 of 382 for:    IFNA2 AND RBV AND genotype

Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial

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ClinicalTrials.gov Identifier: NCT00211692
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : November 21, 2014
Last Update Posted : November 21, 2014
Sponsor:
Collaborators:
Minnesota Veterans Medical Research and Education Foundation
InterMune
Kadmon Pharmaceuticals
US Department of Veterans Affairs
San Diego Veterans Healthcare System
Information provided by (Responsible Party):
Samuel B. Ho, Minneapolis Veterans Affairs Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: consensus interferon (Interferon Alfacon-1) and ribavirin
Drug: Consensus Interferon alfa (CIFN) and ribavirin
Enrollment 64
Recruitment Details Patients with difficult-to-treat characteristics (78% VA) were enrolled at 7 Veterans Affairs (VA) and 2 community medical centers.
Pre-assignment Details All eligible patients were randomized and analysis performed using intention to treat.
Arm/Group Title Group A 52 Weeks Treatment Group B Duration Based on Viral Response
Hide Arm/Group Description Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A) CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
Period Title: Overall Study
Started 33 31
Completed 33 31
Not Completed 0 0
Arm/Group Title Group A 52 Weeks Treatment Group B Duration Based on Viral Response Total
Hide Arm/Group Description Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A) CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B) Total of all reporting groups
Overall Number of Baseline Participants 33 31 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 64 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
 100.0%
31
 100.0%
64
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 31 participants 64 participants
51.4  (8.0) 49.8  (8.8) 50.6  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 64 participants
Female
1
   3.0%
3
   9.7%
4
   6.3%
Male
32
  97.0%
28
  90.3%
60
  93.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 64 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  33.3%
10
  32.3%
21
  32.8%
White
22
  66.7%
19
  61.3%
41
  64.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
   6.5%
2
   3.1%
1.Primary Outcome
Title The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response.
Hide Description Overall sustained virologic response for entire cohort and individual sustained virologic response for different arms of study
Time Frame 24 weeks after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Convenience sample for pilot trial. Analysis is intention to treat.
Arm/Group Title A (52 Weeks Treatment) B (Duration Based on Viral Response)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 33 31
Measure Type: Number
Unit of Measure: participants
11 10
2.Secondary Outcome
Title Number of Participants Discontinuing Early From Study Treatment
Hide Description [Not Specified]
Time Frame through end of study up to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: participants
26
3.Secondary Outcome
Title Participants Achieving SVR Categorized by Time of Response
Hide Description rapid virologic response assessed at 4 weeks, early virologic response assessed at 8-12 weeks, late virologic response assessed at 16-24 weeks
Time Frame 24 weeks after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
participants with analyzable data for this outcome
Arm/Group Title Overall
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: participants
rapid virologic response (n=20) 15
early virologic response (n=13) 4
late virologic response (n=9) 2
4.Secondary Outcome
Title Overall Number of Serious Adverse Events
Hide Description [Not Specified]
Time Frame through end of study up to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: participants
2
Time Frame through end of study up to 72 weeks
Adverse Event Reporting Description adverse events were collected for study population as a whole
 
Arm/Group Title Overall
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Overall
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Overall
Affected / at Risk (%) # Events
Total   2/64 (3.13%)    
General disorders   
chest pain   1/64 (1.56%)  1
Nervous system disorders   
encephalopathy   1/64 (1.56%)  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%
Overall
Affected / at Risk (%) # Events
Total   16/64 (25.00%)    
General disorders   
other intolerable side effects  [1]  9/64 (14.06%)  9
Nervous system disorders   
depression/anxiety   4/64 (6.25%)  4
Skin and subcutaneous tissue disorders   
cellulitis   3/64 (4.69%)  3
Indicates events were collected by systematic assessment
[1]
includes fatigue and irritibility
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
Layout table for Results Point of Contact information
Name/Title: Samuel B. Ho, MD, Chief GI Section
Organization: VA San Diego Healthcare System
Phone: 858-552-8585 ext 2631
EMail: samuel.ho2@va.gov
Layout table for additonal information
Responsible Party: Samuel B. Ho, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00211692     History of Changes
Other Study ID Numbers: MVRI001
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: August 1, 2011
Results First Posted: November 21, 2014
Last Update Posted: November 21, 2014