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A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2) (EXPEDITION-2)

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ClinicalTrials.gov Identifier: NCT02738138
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C Virus Infection
Human Immunodeficiency Virus Infection
Chronic Hepatitis C
Compensated Cirrhosis and Non-cirrhotics
Intervention Drug: ABT-493 coformulated with ABT-530
Enrollment 153
Recruitment Details  
Pre-assignment Details The study included a 35-day screening period.
Arm/Group Title ABT-493/ABT-530 for 8 Weeks ABT-493/ABT-530 for 12 Weeks
Hide Arm/Group Description HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
Period Title: Overall Study
Started 137 16
Completed 134 15
Not Completed 3 1
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             2             0
Other - not further specified             1             0
Arm/Group Title ABT-493/ABT-530 for 8 Weeks ABT-493/ABT-530 for 12 Weeks Total
Hide Arm/Group Description HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 137 16 153
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants 16 participants 153 participants
45.00  (10.22) 50.00  (8.36) 45.00  (10.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 16 participants 153 participants
Female
24
  17.5%
1
   6.3%
25
  16.3%
Male
113
  82.5%
15
  93.8%
128
  83.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 16 participants 153 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
   4.4%
0
   0.0%
6
   3.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
24
  17.5%
1
   6.3%
25
  16.3%
White
106
  77.4%
15
  93.8%
121
  79.1%
More than one race
1
   0.7%
0
   0.0%
1
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Hide Description SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug.
Time Frame 12 weeks after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, all efficacy analyses were performed using the intention-to-treat (ITT) population (all enrolled participants who received at least 1 dose of study drug); in addition, efficacy analyses were performed overall, combining Treatment Arms A and B.
Arm/Group Title ABT-493/ABT-530
Hide Arm/Group Description:
HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
Overall Number of Participants Analyzed 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.0
(95.8 to 100.0)
2.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure
Hide Description On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, all efficacy analyses were performed using the ITT population; in addition, efficacy analyses were performed overall, combining Treatment Arms A and B.
Arm/Group Title ABT-493/ABT-530
Hide Arm/Group Description:
HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
Overall Number of Participants Analyzed 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.7
(0.1 to 3.6)
3.Secondary Outcome
Title Percentage of Participants With Post-treatment Relapse
Hide Description Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Time Frame From the end of treatment through 12 weeks after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, all efficacy analyses were performed using the ITT population including only those participants who had post-treatment data available, excluding reinfection (N = 151). In addition, efficacy analyses were performed overall, combining Treatment Arms A and B.
Arm/Group Title ABT-493/ABT-530
Hide Arm/Group Description:
HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
Overall Number of Participants Analyzed 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 2.5)
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
Adverse Event Reporting Description TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
 
Arm/Group Title ABT-493/ABT-530 for 8 Weeks ABT-493/ABT-530 for 12 Weeks
Hide Arm/Group Description HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
All-Cause Mortality
ABT-493/ABT-530 for 8 Weeks ABT-493/ABT-530 for 12 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/137 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
ABT-493/ABT-530 for 8 Weeks ABT-493/ABT-530 for 12 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/137 (2.19%)      1/16 (6.25%)    
Gastrointestinal disorders     
UPPER GASTROINTESTINAL HAEMORRHAGE  1  1/137 (0.73%)  1 0/16 (0.00%)  0
Nervous system disorders     
CEREBRAL HAEMORRHAGE  1  0/137 (0.00%)  0 1/16 (6.25%)  1
CEREBROVASCULAR ACCIDENT  1  0/137 (0.00%)  0 1/16 (6.25%)  1
Renal and urinary disorders     
CALCULUS URINARY  1  1/137 (0.73%)  1 0/16 (0.00%)  0
Vascular disorders     
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE  1  1/137 (0.73%)  1 0/16 (0.00%)  0
1
Term from vocabulary, MedDRA version 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ABT-493/ABT-530 for 8 Weeks ABT-493/ABT-530 for 12 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/137 (36.50%)      7/16 (43.75%)    
Gastrointestinal disorders     
ABDOMINAL PAIN  1  2/137 (1.46%)  2 1/16 (6.25%)  1
CONSTIPATION  1  1/137 (0.73%)  1 1/16 (6.25%)  1
DENTAL CARIES  1  1/137 (0.73%)  1 1/16 (6.25%)  1
GASTROINTESTINAL SOUNDS ABNORMAL  1  0/137 (0.00%)  0 1/16 (6.25%)  1
NAUSEA  1  12/137 (8.76%)  12 1/16 (6.25%)  1
General disorders     
FATIGUE  1  18/137 (13.14%)  18 0/16 (0.00%)  0
Immune system disorders     
SEASONAL ALLERGY  1  0/137 (0.00%)  0 1/16 (6.25%)  1
Infections and infestations     
CANDIDA INFECTION  1  0/137 (0.00%)  0 1/16 (6.25%)  1
SINUSITIS BACTERIAL  1  0/137 (0.00%)  0 1/16 (6.25%)  1
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  12/137 (8.76%)  12 0/16 (0.00%)  0
Nervous system disorders     
DIZZINESS  1  3/137 (2.19%)  3 1/16 (6.25%)  1
HEADACHE  1  12/137 (8.76%)  12 0/16 (0.00%)  0
Psychiatric disorders     
ANXIETY  1  2/137 (1.46%)  2 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders     
COUGH  1  2/137 (1.46%)  2 1/16 (6.25%)  1
SINUS CONGESTION  1  1/137 (0.73%)  1 1/16 (6.25%)  1
UPPER-AIRWAY COUGH SYNDROME  1  0/137 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders     
PRURITUS  1  3/137 (2.19%)  3 1/16 (6.25%)  1
RASH  1  5/137 (3.65%)  5 1/16 (6.25%)  1
1
Term from vocabulary, MedDRA version 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02738138    
Other Study ID Numbers: M14-730
2015-005577-20 ( EudraCT Number )
First Submitted: April 11, 2016
First Posted: April 14, 2016
Results First Submitted: February 27, 2018
Results First Posted: May 9, 2018
Last Update Posted: May 9, 2018