Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    NCT02765490
Previous Study | Return to List | Next Study

Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection

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.
 
ClinicalTrials.gov Identifier: NCT02765490
Recruitment Status : Completed
First Posted : May 6, 2016
Results First Posted : January 22, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: AL-335
Drug: Odalasvir
Drug: Simeprevir
Enrollment 365
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
Hide Arm/Group Description Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks. Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
Period Title: Overall Study
Started 183 182
Completed 182 179
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             1             1
Other             0             1
Death             0             1
Arm/Group Title Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks Total
Hide Arm/Group Description Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks. Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 183 182 365
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 183 participants 182 participants 365 participants
48
(19 to 69)
49
(18 to 70)
49
(18 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 182 participants 365 participants
Female
88
  48.1%
94
  51.6%
182
  49.9%
Male
95
  51.9%
88
  48.4%
183
  50.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 182 participants 365 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
9
   4.9%
14
   7.7%
23
   6.3%
Native Hawaiian or Other Pacific Islander
1
   0.5%
0
   0.0%
1
   0.3%
Black or African American
9
   4.9%
10
   5.5%
19
   5.2%
White
161
  88.0%
153
  84.1%
314
  86.0%
More than one race
0
   0.0%
2
   1.1%
2
   0.5%
Unknown or Not Reported
3
   1.6%
3
   1.6%
6
   1.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 182 participants 365 participants
Belgium
46
  25.1%
35
  19.2%
81
  22.2%
Canada
33
  18.0%
30
  16.5%
63
  17.3%
Germany
15
   8.2%
17
   9.3%
32
   8.8%
Spain
27
  14.8%
31
  17.0%
58
  15.9%
Italy
24
  13.1%
29
  15.9%
53
  14.5%
Poland
32
  17.5%
29
  15.9%
61
  16.7%
Singapore
6
   3.3%
11
   6.0%
17
   4.7%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
Hide Description The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT.
Time Frame Week 12 (Follow-Up Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population included all randomized participants who took at least 1 dose of the study drug [that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)].
Arm/Group Title Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
Hide Arm/Group Description:
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
Overall Number of Participants Analyzed 183 182
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
98.9
(96.1 to 99.9)
97.8
(94.5 to 99.4)
2.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)
Hide Description The SVR24 was defined as HCV RNA <LLOQ (detectable or undetectable) 24 weeks after End of Treatment (EOT).
Time Frame Week 24 (Follow-Up Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who took at least 1 dose of the study drug (i.e., AL-335, ODV or SMV). Last Observation Carried Forward (LOCF) method was used to impute the missing values.
Arm/Group Title Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
Hide Arm/Group Description:
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
Overall Number of Participants Analyzed 183 182
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
98.9
(96.1 to 99.9)
97.3
(93.7 to 99.1)
3.Secondary Outcome
Title Number of Participants With Viral Relapse
Hide Description Viral Relapse: Participants who did not achieve SVR12, with HCV RNA <LLOQ at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.
Time Frame End of Treatment up to Week 24 (Follow up phase)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV).
Arm/Group Title Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
Hide Arm/Group Description:
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
Overall Number of Participants Analyzed 183 182
Measure Type: Number
Unit of Measure: Participants
1 4
4.Secondary Outcome
Title Number of Participants With Late Viral Relapse
Hide Description Late Viral Relapse: Participants who achieved SVR12 but had confirmed HCV RNA>=LLOQ afterwards during follow-up.
Time Frame Up to Week 24 (Follow-up Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV).
Arm/Group Title Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
Hide Arm/Group Description:
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
Overall Number of Participants Analyzed 183 182
Measure Type: Number
Unit of Measure: Participants
0 1
5.Secondary Outcome
Title Percentage of Participants With On-treatment Failure
Hide Description On-treatment failure: Participants who did not achieve SVR12 and with confirmed HCV RNA>=LLOQ at the End of Treatment (EOT).
Time Frame EOT up to Week 12 (Follow up Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV).
Arm/Group Title Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
Hide Arm/Group Description:
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
Overall Number of Participants Analyzed 183 182
Measure Type: Number
Unit of Measure: Percentage of Participants
0 0
6.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)
Hide Description The SVR 4 was defined as participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).
Time Frame Week 4 (Follow-Up Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV).
Arm/Group Title Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
Hide Arm/Group Description:
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
Overall Number of Participants Analyzed 183 182
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
99.5
(97.0 to 100.0)
98.4
(95.3 to 99.7)
Time Frame Screening up to Follow-up (Week 24)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
Hide Arm/Group Description Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks. Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks.
All-Cause Mortality
Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/183 (0.00%)   1/182 (0.55%) 
Hide Serious Adverse Events
Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   7/183 (3.83%)   4/182 (2.20%) 
Gastrointestinal disorders     
Intestinal Obstruction * 1  1/183 (0.55%)  0/182 (0.00%) 
Intestinal Strangulation * 1  1/183 (0.55%)  0/182 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/183 (0.55%)  0/182 (0.00%) 
Infections and infestations     
Infective Keratitis * 1  0/183 (0.00%)  1/182 (0.55%) 
Lower Respiratory Tract Infection * 1  0/183 (0.00%)  1/182 (0.55%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  1/183 (0.55%)  0/182 (0.00%) 
Bursitis * 1  1/183 (0.55%)  0/182 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign Breast Neoplasm * 1  0/183 (0.00%)  1/182 (0.55%) 
Glioblastoma * 1  0/183 (0.00%)  1/182 (0.55%) 
Nervous system disorders     
Ivth Nerve Paresis * 1  1/183 (0.55%)  0/182 (0.00%) 
Parkinsonism * 1  1/183 (0.55%)  0/182 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Choking * 1  1/183 (0.55%)  0/182 (0.00%) 
Vascular disorders     
Hypertension * 1  1/183 (0.55%)  0/182 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   83/183 (45.36%)   85/182 (46.70%) 
Gastrointestinal disorders     
Diarrhoea * 1  7/183 (3.83%)  10/182 (5.49%) 
Nausea * 1  13/183 (7.10%)  5/182 (2.75%) 
General disorders     
Asthenia * 1  11/183 (6.01%)  8/182 (4.40%) 
Fatigue * 1  27/183 (14.75%)  21/182 (11.54%) 
Infections and infestations     
Viral Upper Respiratory Tract Infection * 1  13/183 (7.10%)  19/182 (10.44%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  8/183 (4.37%)  12/182 (6.59%) 
Myalgia * 1  10/183 (5.46%)  13/182 (7.14%) 
Nervous system disorders     
Headache * 1  40/183 (21.86%)  40/182 (21.98%) 
Psychiatric disorders     
Insomnia * 1  15/183 (8.20%)  15/182 (8.24%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-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.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Physician, Medical Department
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02765490    
Other Study ID Numbers: CR108070
64294178HPC2001 ( Other Identifier: Janssen Research & Development, LLC )
2015-004200-38 ( EudraCT Number )
First Submitted: May 5, 2016
First Posted: May 6, 2016
Results First Submitted: August 6, 2018
Results First Posted: January 22, 2019
Last Update Posted: November 20, 2019