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Trial record 1 of 1 for:    NCT01888900
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New Treatment Response in People With and Without Cirrhosis From Chronic Hepatitis C

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier:
NCT01888900
First received: June 26, 2013
Last updated: December 14, 2016
Last verified: December 2016
Results First Received: November 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cirrhosis
Chronic Hepatitis C
Hepatitis C
Hepatitis C, Chronic
Interventions: Drug: DUAL
Drug: QUAD

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hepatitis C Virus Genotype 1A Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
Hepatitis C Virus Genotype 1B Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.

Participant Flow:   Overall Study
    Hepatitis C Virus Genotype 1A   Hepatitis C Virus Genotype 1B
STARTED   22   13 
COMPLETED [1]   22   11 
NOT COMPLETED   0   2 
failed treatment                0                2 
[1] 2 failures were switched from DUAL treatment to QUAD treatment.



  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.
No text entered.

Reporting Groups
  Description
Hepatitis C Virus Genotype 1A subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
Hepatitis C Virus Genotype 1B Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Hepatitis C Virus Genotype 1A   Hepatitis C Virus Genotype 1B   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   13   35 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.50  (7.65)   59.31  (11.06)   57.54  (9.01) 
Gender 
[Units: Participants]
Count of Participants
     
Female      5  22.7%      6  46.2%      11  31.4% 
Male      17  77.3%      7  53.8%      24  68.6% 
ALT [1] 
[Units: U/L]
Mean (Standard Deviation)
 99.36  (52.84)   78.08  (42.18)   91.46  (49.68) 
[1] alanine aminotransferase
HCV RNA level [1] 
[Units: log10(IU/ml)]
Mean (Standard Deviation)
 6.67  (0.49)   6.72  (0.37)   6.69  (0.44) 
[1] log with base 10 transformed HCV RNA
Race 
[Units: Participants]
     
Asian   1   2   3 
Black   9   4   13 
White   12   7   19 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Changes in Interferon Stimulated Genes in the Liver   [ Time Frame: baseline and either 2 or 4 weeks ]

2.  Secondary:   Rates of Rapid Virological Responder   [ Time Frame: Week 4 post treatment ]

3.  Secondary:   Extended Rapid Virological Responder   [ Time Frame: Both weeks 4 and 12 post treatment ]

4.  Secondary:   End of Treatment Responder   [ Time Frame: Week 24 post treatment ]

5.  Secondary:   Sustained Virological Responder   [ Time Frame: Week 12 post treatment ]

6.  Secondary:   Serum Aminotransferase Levels   [ Time Frame: Week 12 post treatment ]

7.  Secondary:   Virological Relapse   [ Time Frame: beyond Week 24 post treatment ]

8.  Secondary:   Rates of Asunaprevir and Daclatasvir Resistance   [ Time Frame: post treatment ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Marc Ghany
Organization: National Institute of Diabetes and Digestive and Kidney Diseases
phone: 301-402-5515
e-mail: marcg@mail.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT01888900     History of Changes
Other Study ID Numbers: 130150
13-DK-0150
13-DK-0150 ( Other Identifier: National Institutes of Health )
Study First Received: June 26, 2013
Results First Received: November 14, 2016
Last Updated: December 14, 2016