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Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial

This study has been completed.
Sponsor:
Collaborators:
Minnesota Veterans Medical Research and Education Foundation
InterMune
Kadmon Pharmaceuticals
VA Office of Research and Development
San Diego Veterans Healthcare System
Information provided by (Responsible Party):
Samuel B. Ho, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00211692
First received: September 13, 2005
Last updated: November 20, 2014
Last verified: November 2014
Results First Received: August 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with difficult-to-treat characteristics (78% VA) were enrolled at 7 Veterans Affairs (VA) and 2 community medical centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All eligible patients were randomized and analysis performed using intention to treat.

Reporting Groups
  Description
Group A 52 Weeks Treatment Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
Group B Duration Based on Viral Response 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)

Participant Flow:   Overall Study
    Group A 52 Weeks Treatment   Group B Duration Based on Viral Response
STARTED   33   31 
COMPLETED   33   31 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Group A 52 Weeks Treatment Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
Group B Duration Based on Viral Response 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 Total of all reporting groups

Baseline Measures
   Group A 52 Weeks Treatment   Group B Duration Based on Viral Response   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   31   64 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   33   31   64 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.4  (8.0)   49.8  (8.8)   50.6  (8.4) 
Gender 
[Units: Participants]
     
Female   1   3   4 
Male   32   28   60 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   11   10   21 
White   22   19   41 
More than one race   0   0   0 
Unknown or Not Reported   0   2   2 


  Outcome Measures
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1.  Primary:   The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response.   [ Time Frame: 24 weeks after the end of treatment ]

2.  Secondary:   Number of Participants Discontinuing Early From Study Treatment   [ Time Frame: through end of study up to 72 weeks ]

3.  Secondary:   Participants Achieving SVR Categorized by Time of Response   [ Time Frame: 24 weeks after end of treatment ]

4.  Secondary:   Overall Number of Serious Adverse Events   [ Time Frame: through end of study up to 72 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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: Samuel B. Ho, MD, Chief GI Section
Organization: VA San Diego Healthcare System
phone: 858-552-8585 ext 2631
e-mail: samuel.ho2@va.gov


Publications of Results:

Responsible Party: Samuel B. Ho, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00211692     History of Changes
Other Study ID Numbers: MVRI001
Study First Received: September 13, 2005
Results First Received: August 1, 2011
Last Updated: November 20, 2014
Health Authority: United States: Food and Drug Administration