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A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

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: NCT02442271
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C Infection
Interventions Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
Drug: ribavirin
Enrollment 222
Recruitment Details  
Pre-assignment Details Treatment regimen was assigned according to HCV genotype/subtype and cirrhosis status.
Arm/Group Title 3-DAA ± RBV
Hide Arm/Group Description 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
Period Title: Overall Study
Started 222
Completed 218
Not Completed 4
Reason Not Completed
Adverse Event             1
Withdrew Consent             1
Lost to Follow-up             1
Other             1
Arm/Group Title 3-DAA ± RBV
Hide Arm/Group Description 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
Overall Number of Baseline Participants 222
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 222 participants
56.6  (10.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants
Female 99
Male 123
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 study drug. Participants with missing data were counted as failures.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who received at least 1 dose of study drug.
Arm/Group Title 3-DAA ± RBV
Hide Arm/Group Description:
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
Overall Number of Participants Analyzed 222
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.4
(93.1 to 98.2)
2.Secondary Outcome
Title Percentage of Participants With SVR12 by Fibrosis Stage
Hide Description SVR12 was defined as plasma HCV RNA level <LLOQ]12 weeks after the last dose of study drug. The percentage of participants achieving SVR12 by fibrosis stage (F3 and F4) are presented. Participants with missing data were counted as failures.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population.
Arm/Group Title Fibrosis Stage F3 Fibrosis Stage F4
Hide Arm/Group Description:
Participants with baseline fibrosis stage F3 (without cirrhosis).
Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
Overall Number of Participants Analyzed 89 133
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.6
(90.6 to 98.8)
96.2
(91.5 to 98.4)
3.Secondary Outcome
Title Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience
Hide Description SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' prior HCV treatment experience at screening. Participants with missing data were counted as failures.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population.
Arm/Group Title Treatment-Naive Pegylated Interferon (PegIFN)/RBV Null Responders Pegylated Interferon (PegIFN)//RBV Partial Responders Pegylated Interferon (PegIFN)/RBV Non-Responders Pegylated Interferon (PegIFN)/RBV Relapser Pegylated Interferon (PegIFN)/RBV Breakthrough IFN Interolerant Other
Hide Arm/Group Description:
Participants who had never received any antiviral treatment for HCV infection.
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course but failed to achieve HCV RNA undetectable at the end of treatment
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course.
Participants who had received prior treatment with pegIFN-based therapy for HCV infection who achieved HCV undetectable at end of a prior IFN/RBV or pegIFN/RBV treatment course but HCV RNA was detectable following cessation of therapy
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least one documented result of HCV RNA undetectable during a prior IFN/RBV or pegIFN/RBV treatment course
Participants who did not meet any of the other definitions of treatment failure and discontinued IFN/RBV or pegIFN/RBV therapy due to IFN intolerability
Participants who received IFN treatment, including IFN or pegIFN monotherapy, IFN/RBV, or pegIFN/RBV experienced subjects. Includes subjects who do not have adequate documentation of response.
Overall Number of Participants Analyzed 102 22 7 26 34 12 7 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.1
(90.3 to 98.5)
95.5
(78.2 to 99.2)
100 [1] 
(NA to NA)
100
(87.1 to 100.0)
97.1
(85.1 to 99.5)
100
(78.5 to 100.00)
85.7 [1] 
(NA to NA)
91.7
(64.6 to 98.5)
[1]
The number of participants analyzed is <10
4.Secondary Outcome
Title Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening
Hide Description SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' eligibility for treatment with IFN at screening. Participants with missing data were counted as failures.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population.
Arm/Group Title Interferon (IFN)-Ineligible, Treatment-Naive Interferon (IFN)-Eligible, Treatment-Naive Interferon (IFN)-Ineligible, Treatment-Experienced Interferon (IFN)-Eligible, Treatment-Experienced
Hide Arm/Group Description:
Participants who had never received any antiviral treatment for HCV infection and were ineligible for treatment with IFN at screening.
Participants who had never received any antiviral treatment for HCV infection and were eligible for treatment with IFN at screening.
Participants who had received prior antiviral treatment for HCV infection and were ineligible for treatment with IFN at screening.
Participants who had received prior antiviral treatment for HCV infection and were eligible for treatment with IFN at screening.
Overall Number of Participants Analyzed 10 92 7 113
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90.0
(59.6 to 98.2)
96.7
(90.8 to 98.9)
85.7 [1] 
(NA to NA)
97.3
(92.5 to 99.1)
[1]
The number of participants analyzed is <10
5.Secondary Outcome
Title Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
Hide Description The HCV-PRO has been developed to capture the function and well-being impact of HCV conditions and treatment and contains 16 items important to HCV-infected patients; items were totaled to a summary score. Scores range from 0 to 100. A higher HCV-PRO score indicates a better state of health and a decrease from baseline represents worsening. If a participant answered at least 12 of the 16 items, the missing items were imputed with the mean score of the answered items; if a participant did not answer at least 12 of the items, the total score was considered missing.
Time Frame Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Fibrosis Stage F3 Fibrosis Stage F4
Hide Arm/Group Description:
Participants with baseline fibrosis stage F3 (without cirrhosis).
Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
Overall Number of Participants Analyzed 88 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
SVR12 Not Achieved Number Analyzed 3 participants 4 participants
0.5  (10.97) 0.8  (10.64)
SVR12 Achieved Number Analyzed 85 participants 126 participants
3.8  (13.25) 4.2  (15.72)
6.Secondary Outcome
Title Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
Hide Description The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain
Time Frame Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Fibrosis Stage F3 Fibrosis Stage F4
Hide Arm/Group Description:
Participants with baseline fibrosis stage F3 (without cirrhosis).
Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
Overall Number of Participants Analyzed 87 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
SVR12 Not Achieved Number Analyzed 3 participants 4 participants
-0.5  (9.22) 1.3  (8.59)
SVR12 Achieved Number Analyzed 84 participants 127 participants
0.1  (6.42) 2.1  (7.60)
7.Secondary Outcome
Title (SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
Hide Description The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a PCS score and a MCS score. Scores SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain was missing.
Time Frame Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT population with evaluable data.
Arm/Group Title Fibrosis Stage F3 Fibrosis Stage F4
Hide Arm/Group Description:
Participants with baseline fibrosis stage F3 (without cirrhosis).
Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
Overall Number of Participants Analyzed 87 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
SVR12 Not Achieved Number Analyzed 3 participants 4 participants
2.4  (3.72) -0.6  (8.47)
SVR12 Achieved Number Analyzed 84 participants 127 participants
2.4  (11.39) 2.5  (9.15)
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 28 weeks).
Adverse Event Reporting Description TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
 
Arm/Group Title 3-DAA ± RBV
Hide Arm/Group Description 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
All-Cause Mortality
3-DAA ± RBV
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
3-DAA ± RBV
Affected / at Risk (%)
Total   6/222 (2.70%) 
Gastrointestinal disorders   
DIARRHOEA  1  1/222 (0.45%) 
OESOPHAGEAL VARICES HAEMORRHAGE  1  1/222 (0.45%) 
Hepatobiliary disorders   
HEPATIC FAILURE  1  1/222 (0.45%) 
Infections and infestations   
GASTROENTERITIS  1  1/222 (0.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
LUNG ADENOCARCINOMA METASTATIC  1  1/222 (0.45%) 
Nervous system disorders   
TRANSIENT ISCHAEMIC ATTACK  1  1/222 (0.45%) 
Renal and urinary disorders   
RENAL FAILURE  1  1/222 (0.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
3-DAA ± RBV
Affected / at Risk (%)
Total   139/222 (62.61%) 
Blood and lymphatic system disorders   
ANAEMIA  1  16/222 (7.21%) 
Gastrointestinal disorders   
DIARRHOEA  1  19/222 (8.56%) 
DYSPEPSIA  1  15/222 (6.76%) 
NAUSEA  1  34/222 (15.32%) 
General disorders   
ASTHENIA  1  20/222 (9.01%) 
FATIGUE  1  41/222 (18.47%) 
Nervous system disorders   
HEADACHE  1  48/222 (21.62%) 
Psychiatric disorders   
INSOMNIA  1  12/222 (5.41%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  14/222 (6.31%) 
Skin and subcutaneous tissue disorders   
PRURITUS  1  32/222 (14.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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: NCT02442271    
Other Study ID Numbers: M14-225
First Submitted: May 11, 2015
First Posted: May 13, 2015
Results First Submitted: June 29, 2017
Results First Posted: August 1, 2017
Last Update Posted: August 1, 2017