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Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

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ClinicalTrials.gov Identifier: NCT02493855
Recruitment Status : Completed
First Posted : July 10, 2015
Results First Posted : May 15, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Hepatitis C
Hepatitis C (HCV)
Hepatitis C Genotype 1a
Interventions Drug: Ombitasvir/ABT-450/Ritonavir
Drug: Dasabuvir
Drug: Ribavirin (RBV)
Enrollment 46
Recruitment Details This study was conducted at one clinic in France and one clinic in the United States. Participants were treatment-naïve adults with hepatitis C virus (HCV) genotype (GT)1a infection without cirrhosis.
Pre-assignment Details Participants were randomized to Arms A or B in a 1:1 ratio first, and once those arms fully enrolled, Arm C was enrolled. Randomization to Arms A and B was stratified by site.
Arm/Group Title Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks
Hide Arm/Group Description Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
Period Title: Overall Study
Started 21 19 6
Completed 19 18 6
Not Completed 2 1 0
Reason Not Completed
Non-compliance             1             0             0
Adverse Event             0             1             0
Withdrawal by Subject             1             0             0
Arm/Group Title Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks Total
Hide Arm/Group Description Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 21 19 6 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 6 participants 46 participants
44.9  (11.96) 46.0  (12.78) 36.7  (15.79) 44.3  (12.88)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 6 participants 46 participants
< 55 years
17
  81.0%
14
  73.7%
5
  83.3%
36
  78.3%
≥ 55 - 65 years
4
  19.0%
5
  26.3%
1
  16.7%
10
  21.7%
≥ 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 6 participants 46 participants
Female
11
  52.4%
12
  63.2%
4
  66.7%
27
  58.7%
Male
10
  47.6%
7
  36.8%
2
  33.3%
19
  41.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 6 participants 46 participants
White
16
  76.2%
14
  73.7%
4
  66.7%
34
  73.9%
Black of African American
4
  19.0%
3
  15.8%
1
  16.7%
8
  17.4%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
American Indian or Alaskan Native
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%
Mutli Race
1
   4.8%
2
  10.5%
1
  16.7%
4
   8.7%
1.Primary Outcome
Title Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment
Hide Description HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm.
Time Frame From Week 0 to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable HCV RNA to calculate the slope of the second phase. Three participants were excluded due to algorithm non-convergence in the non-linear modeling process.
Arm/Group Title Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks
Hide Arm/Group Description:
Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
Overall Number of Participants Analyzed 20 17 6
Median (Full Range)
Unit of Measure: 1/day
0.0036
(0.0006 to 0.0128)
0.0046
(-0.0003 to 0.0155)
0.0051
(0.0031 to 0.0076)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Ribavirin Full Dose for Last 10 Weeks, Arm B: Ribavirin Full Dose for 12 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority
Comments This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.
Statistical Test of Hypothesis P-Value 0.311
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm B: Ribavirin Full Dose for 12 Weeks, Arm C: Ribavirin Low-dose for 12 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority
Comments This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.
Statistical Test of Hypothesis P-Value 0.561
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Time Frame From first dose of study drug until 30 days after last dose; up to 16 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks
Hide Arm/Group Description Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
All-Cause Mortality
Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/21 (4.76%)   0/19 (0.00%)   0/6 (0.00%) 
Psychiatric disorders       
DEPRESSION  1  1/21 (4.76%)  0/19 (0.00%)  0/6 (0.00%) 
DRUG DEPENDENCE  1  1/21 (4.76%)  0/19 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/21 (80.95%)   16/19 (84.21%)   6/6 (100.00%) 
Blood and lymphatic system disorders       
ANAEMIA  1  4/21 (19.05%)  4/19 (21.05%)  2/6 (33.33%) 
INCREASED TENDENCY TO BRUISE  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
LYMPHADENOPATHY  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
Cardiac disorders       
PALPITATIONS  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
Ear and labyrinth disorders       
VERTIGO  1  0/21 (0.00%)  2/19 (10.53%)  0/6 (0.00%) 
Eye disorders       
DRY EYE  1  0/21 (0.00%)  0/19 (0.00%)  1/6 (16.67%) 
Gastrointestinal disorders       
ABDOMINAL DISCOMFORT  1  1/21 (4.76%)  1/19 (5.26%)  0/6 (0.00%) 
ABDOMINAL PAIN  1  3/21 (14.29%)  3/19 (15.79%)  1/6 (16.67%) 
ABDOMINAL PAIN UPPER  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
CONSTIPATION  1  2/21 (9.52%)  0/19 (0.00%)  1/6 (16.67%) 
DIARRHOEA  1  1/21 (4.76%)  0/19 (0.00%)  1/6 (16.67%) 
DRY MOUTH  1  1/21 (4.76%)  1/19 (5.26%)  2/6 (33.33%) 
DYSPEPSIA  1  0/21 (0.00%)  2/19 (10.53%)  3/6 (50.00%) 
HAEMATOCHEZIA  1  0/21 (0.00%)  0/19 (0.00%)  1/6 (16.67%) 
NAUSEA  1  3/21 (14.29%)  3/19 (15.79%)  2/6 (33.33%) 
RECTAL HAEMORRHAGE  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
VOMITING  1  3/21 (14.29%)  0/19 (0.00%)  1/6 (16.67%) 
General disorders       
ASTHENIA  1  3/21 (14.29%)  3/19 (15.79%)  0/6 (0.00%) 
FATIGUE  1  5/21 (23.81%)  7/19 (36.84%)  2/6 (33.33%) 
FEELING ABNORMAL  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
PYREXIA  1  0/21 (0.00%)  0/19 (0.00%)  1/6 (16.67%) 
Hepatobiliary disorders       
HYPERBILIRUBINAEMIA  1  2/21 (9.52%)  0/19 (0.00%)  2/6 (33.33%) 
HYPERTRANSAMINASAEMIA  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
Infections and infestations       
BRONCHITIS  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
FUNGAL SKIN INFECTION  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
INFLUENZA  1  1/21 (4.76%)  0/19 (0.00%)  0/6 (0.00%) 
ORAL CANDIDIASIS  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
URINARY TRACT INFECTION  1  1/21 (4.76%)  0/19 (0.00%)  1/6 (16.67%) 
Injury, poisoning and procedural complications       
LIMB INJURY  1  1/21 (4.76%)  0/19 (0.00%)  1/6 (16.67%) 
PROCEDURAL HEADACHE  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
PROCEDURAL PAIN  1  7/21 (33.33%)  5/19 (26.32%)  5/6 (83.33%) 
Investigations       
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
ALANINE AMINOTRANSFERASE INCREASED  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
BODY TEMPERATURE FLUCTUATION  1  0/21 (0.00%)  0/19 (0.00%)  1/6 (16.67%) 
GLUCOSE URINE PRESENT  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
HAEMOGLOBIN DECREASED  1  1/21 (4.76%)  3/19 (15.79%)  0/6 (0.00%) 
INTERNATIONAL NORMALISED RATIO INCREASED  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
PROTHROMBIN LEVEL INCREASED  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
Metabolism and nutrition disorders       
DEHYDRATION  1  0/21 (0.00%)  0/19 (0.00%)  1/6 (16.67%) 
HYPERGLYCAEMIA  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
HYPERMAGNESAEMIA  1  0/21 (0.00%)  1/19 (5.26%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
BACK PAIN  1  2/21 (9.52%)  1/19 (5.26%)  2/6 (33.33%) 
FLANK PAIN  1  0/21 (0.00%)  0/19 (0.00%)  1/6 (16.67%) 
MUSCLE TIGHTNESS  1  0/21 (0.00%)  0/19 (0.00%)  1/6 (16.67%) 
MUSCULOSKELETAL CHEST PAIN  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
MUSCULOSKELETAL PAIN  1  2/21 (9.52%)  1/19 (5.26%)  0/6 (0.00%) 
MYALGIA  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
Nervous system disorders       
AMNESIA  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
DIZZINESS  1  0/21 (0.00%)  2/19 (10.53%)  0/6 (0.00%) 
HEADACHE  1  4/21 (19.05%)  4/19 (21.05%)  0/6 (0.00%) 
MEMORY IMPAIRMENT  1  0/21 (0.00%)  3/19 (15.79%)  0/6 (0.00%) 
MIGRAINE  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
SYNCOPE  1  1/21 (4.76%)  1/19 (5.26%)  0/6 (0.00%) 
Psychiatric disorders       
ANXIETY  1  1/21 (4.76%)  0/19 (0.00%)  1/6 (16.67%) 
CONFUSIONAL STATE  1  0/21 (0.00%)  0/19 (0.00%)  1/6 (16.67%) 
DEPRESSED MOOD  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
DEPRESSION  1  3/21 (14.29%)  2/19 (10.53%)  0/6 (0.00%) 
EMOTIONAL DISTRESS  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
INSOMNIA  1  3/21 (14.29%)  3/19 (15.79%)  0/6 (0.00%) 
IRRITABILITY  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
MOOD SWINGS  1  0/21 (0.00%)  0/19 (0.00%)  1/6 (16.67%) 
SLEEP DISORDER  1  0/21 (0.00%)  0/19 (0.00%)  1/6 (16.67%) 
Renal and urinary disorders       
CHROMATURIA  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
DYSURIA  1  0/21 (0.00%)  0/19 (0.00%)  1/6 (16.67%) 
Reproductive system and breast disorders       
POLYMENORRHOEA  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
DYSPNOEA  1  2/21 (9.52%)  0/19 (0.00%)  1/6 (16.67%) 
OROPHARYNGEAL PAIN  1  1/21 (4.76%)  1/19 (5.26%)  1/6 (16.67%) 
RESPIRATORY TRACT CONGESTION  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
SINUS CONGESTION  1  0/21 (0.00%)  1/19 (5.26%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders       
ALOPECIA  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
ANGIOEDEMA  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
DERMATITIS CONTACT  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
DRY SKIN  1  0/21 (0.00%)  2/19 (10.53%)  0/6 (0.00%) 
PRURITUS  1  3/21 (14.29%)  6/19 (31.58%)  1/6 (16.67%) 
RASH  1  0/21 (0.00%)  1/19 (5.26%)  2/6 (33.33%) 
RASH GENERALISED  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
Vascular disorders       
FLUSHING  1  0/21 (0.00%)  1/19 (5.26%)  1/6 (16.67%) 
HYPOTENSION  1  0/21 (0.00%)  1/19 (5.26%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
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
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02493855     History of Changes
Other Study ID Numbers: M14-242
2014-001478-32 ( EudraCT Number )
First Submitted: July 2, 2015
First Posted: July 10, 2015
Results First Submitted: April 6, 2017
Results First Posted: May 15, 2017
Last Update Posted: October 31, 2017