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Combination Therapy for Chronic Hepatitis C Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01805882
First Posted: March 6, 2013
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Results First Submitted: February 28, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: Sofosbuvir
Drug: Ledipasvir
Drug: GS-9669
Drug: GS-9451

  Participant Flow
  Hide Participant Flow

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
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669 Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451 Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451 Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451 Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669 Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease

Participant Flow:   Overall Study
    A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir   B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669   C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451   D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir   D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir   E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir   F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451   G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451   H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
STARTED   20   20   20   34   14   21   50   25   25 
COMPLETED   20   20   19   32   14   20   48   25   24 
NOT COMPLETED   0   0   1   2   0   1   2   0   1 



  Baseline Characteristics
  Hide Baseline Characteristics

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
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669 Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451 Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451 Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451 Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669 Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
Total Total of all reporting groups

Baseline Measures
   A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir   B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669   C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451   D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir   D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir   E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir   F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451   G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451   H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   20   34   14   21   50   25   25   229 
Age 
[Units: Participants]
Count of Participants
                   
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      19  95.0%      19  95.0%      19  95.0%      27  79.4%      11  78.6%      19  90.5%      48  96.0%      24  96.0%      19  76.0%      205  89.5% 
>=65 years      1   5.0%      1   5.0%      1   5.0%      7  20.6%      3  21.4%      2   9.5%      2   4.0%      1   4.0%      6  24.0%      24  10.5% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                   
Female      6  30.0%      8  40.0%      4  20.0%      6  17.6%      1   7.1%      7  33.3%      17  34.0%      8  32.0%      6  24.0%      63  27.5% 
Male      14  70.0%      12  60.0%      16  80.0%      28  82.4%      13  92.9%      14  66.7%      33  66.0%      17  68.0%      19  76.0%      166  72.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
                   
Hispanic or Latino      1   5.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      3   6.0%      1   4.0%      0   0.0%      5   2.2% 
Not Hispanic or Latino      19  95.0%      20 100.0%      20 100.0%      34 100.0%      14 100.0%      21 100.0%      46  92.0%      24  96.0%      25 100.0%      223  97.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   2.0%      0   0.0%      0   0.0%      1   0.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
                   
American Indian or Alaska Native      1   5.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   4.8%      0   0.0%      0   0.0%      0   0.0%      2   0.9% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      15  75.0%      19  95.0%      18  90.0%      28  82.4%      13  92.9%      9  42.9%      29  58.0%      19  76.0%      19  76.0%      169  73.8% 
White      3  15.0%      1   5.0%      2  10.0%      5  14.7%      1   7.1%      11  52.4%      17  34.0%      4  16.0%      5  20.0%      49  21.4% 
More than one race      1   5.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      2   4.0%      1   4.0%      0   0.0%      4   1.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      1   2.9%      0   0.0%      0   0.0%      2   4.0%      1   4.0%      1   4.0%      5   2.2% 


  Outcome Measures

1.  Primary:   The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs   [ Time Frame: 12 weeks after stop of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Shyam Kottilil MD
Organization: National Institute of Allergy and Infectious Diseases
phone: +1 410 706 4872
e-mail: Skottilil@ihv.umaryland.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01805882     History of Changes
Other Study ID Numbers: 130066
13-I-0066 ( Other Identifier: NIH )
First Submitted: March 5, 2013
First Posted: March 6, 2013
Results First Submitted: February 28, 2017
Results First Posted: April 11, 2017
Last Update Posted: June 8, 2017