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Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease

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ClinicalTrials.gov Identifier: NCT02487199
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : December 4, 2017
Last Update Posted : December 4, 2017
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
Condition Hepatitis C Virus (HCV)
Interventions Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
Drug: ombitasvir/paritaprevir/ritonavir
Enrollment 18
Recruitment Details  
Pre-assignment Details This study included a 42-day screening period.
Arm/Group Title HCV GT1a (3-DAA) HCV GT4 (2-DAA)
Hide Arm/Group Description Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
Period Title: Overall Study
Started 13 5
Completed 13 4
Not Completed 0 1
Reason Not Completed
Withdrew Consent             0             1
Arm/Group Title HCV GT1a (3-DAA) HCV GT4 (2-DAA) Total
Hide Arm/Group Description Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 13 5 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 5 participants 18 participants
54.8  (10.00) 53.6  (14.08) 54.5  (10.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 5 participants 18 participants
Female 4 2 6
Male 9 3 12
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 after backward imputation were imputed as nonresponders.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.
Arm/Group Title HCV GT1a (3-DAA) HCV GT4 (2-DAA)
Hide Arm/Group Description:
Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
Overall Number of Participants Analyzed 13 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(77.2 to 100.0)
80.0
(37.6 to 96.4)
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity from first dose of study drug until 30 days after the last dose. For more details on AEs please see the Adverse Event section.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received at least 1 dose of study drug.
Arm/Group Title HCV GT1a (3-DAA) HCV GT4 (2-DAA)
Hide Arm/Group Description:
Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
Overall Number of Participants Analyzed 13 5
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE 13 5
Any TESAE 3 1
3.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure
Hide Description On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment or confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment with at least 6 weeks of treatment.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HCV GT1a (3-DAA) HCV GT4 (2-DAA)
Hide Arm/Group Description:
Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
Overall Number of Participants Analyzed 13 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 22.8)
0.0
(0.0 to 43.4)
4.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
All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.
Arm/Group Title HCV GT1a (3-DAA) HCV GT4 (2-DAA)
Hide Arm/Group Description:
Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
Overall Number of Participants Analyzed 13 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 22.8)
0.0
(0.0 to 49.0)
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 TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
 
Arm/Group Title HCV GT1a (3-DAA) HCV GT4 (2-DAA)
Hide Arm/Group Description Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
All-Cause Mortality
HCV GT1a (3-DAA) HCV GT4 (2-DAA)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
HCV GT1a (3-DAA) HCV GT4 (2-DAA)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/13 (23.08%)   1/5 (20.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  1/13 (7.69%)  0/5 (0.00%) 
Infections and infestations     
FOLLICULITIS  1  1/13 (7.69%)  0/5 (0.00%) 
GASTROENTERITIS  1  1/13 (7.69%)  0/5 (0.00%) 
Renal and urinary disorders     
END STAGE RENAL DISEASE  1  0/13 (0.00%)  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders     
PULMONARY OEDEMA  1  1/13 (7.69%)  0/5 (0.00%) 
Vascular disorders     
HYPERTENSION  1  1/13 (7.69%)  0/5 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HCV GT1a (3-DAA) HCV GT4 (2-DAA)
Affected / at Risk (%) Affected / at Risk (%)
Total   13/13 (100.00%)   5/5 (100.00%) 
Cardiac disorders     
PALPITATIONS  1  1/13 (7.69%)  1/5 (20.00%) 
Ear and labyrinth disorders     
VERTIGO  1  1/13 (7.69%)  0/5 (0.00%) 
Endocrine disorders     
CUSHING'S SYNDROME  1  1/13 (7.69%)  0/5 (0.00%) 
HYPERPARATHYROIDISM  1  0/13 (0.00%)  1/5 (20.00%) 
Eye disorders     
DRY EYE  1  1/13 (7.69%)  0/5 (0.00%) 
VISION BLURRED  1  1/13 (7.69%)  0/5 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL DISCOMFORT  1  1/13 (7.69%)  0/5 (0.00%) 
ABDOMINAL DISTENSION  1  1/13 (7.69%)  0/5 (0.00%) 
ABDOMINAL PAIN  1  3/13 (23.08%)  0/5 (0.00%) 
ABDOMINAL PAIN UPPER  1  1/13 (7.69%)  0/5 (0.00%) 
CONSTIPATION  1  2/13 (15.38%)  0/5 (0.00%) 
DIARRHOEA  1  4/13 (30.77%)  0/5 (0.00%) 
FLATULENCE  1  1/13 (7.69%)  0/5 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  2/13 (15.38%)  0/5 (0.00%) 
NAUSEA  1  4/13 (30.77%)  0/5 (0.00%) 
SALIVARY GLAND CALCULUS  1  1/13 (7.69%)  0/5 (0.00%) 
VOMITING  1  2/13 (15.38%)  0/5 (0.00%) 
General disorders     
ASTHENIA  1  1/13 (7.69%)  0/5 (0.00%) 
CHEST PAIN  1  1/13 (7.69%)  0/5 (0.00%) 
FATIGUE  1  3/13 (23.08%)  1/5 (20.00%) 
OEDEMA PERIPHERAL  1  0/13 (0.00%)  1/5 (20.00%) 
PAIN  1  1/13 (7.69%)  0/5 (0.00%) 
PYREXIA  1  1/13 (7.69%)  0/5 (0.00%) 
Infections and infestations     
BRONCHITIS  1  1/13 (7.69%)  0/5 (0.00%) 
KIDNEY INFECTION  1  1/13 (7.69%)  0/5 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  2/13 (15.38%)  0/5 (0.00%) 
URINARY TRACT INFECTION  1  1/13 (7.69%)  1/5 (20.00%) 
Investigations     
TRANSAMINASES INCREASED  1  1/13 (7.69%)  0/5 (0.00%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  1/13 (7.69%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  1/13 (7.69%)  0/5 (0.00%) 
MUSCULAR WEAKNESS  1  1/13 (7.69%)  0/5 (0.00%) 
MYALGIA  1  0/13 (0.00%)  1/5 (20.00%) 
NECK PAIN  1  1/13 (7.69%)  0/5 (0.00%) 
Nervous system disorders     
BURNING SENSATION  1  0/13 (0.00%)  1/5 (20.00%) 
DIZZINESS  1  1/13 (7.69%)  0/5 (0.00%) 
HEADACHE  1  3/13 (23.08%)  0/5 (0.00%) 
SCIATICA  1  1/13 (7.69%)  0/5 (0.00%) 
Psychiatric disorders     
CONFUSIONAL STATE  1  1/13 (7.69%)  0/5 (0.00%) 
EUPHORIC MOOD  1  1/13 (7.69%)  0/5 (0.00%) 
INSOMNIA  1  2/13 (15.38%)  0/5 (0.00%) 
SLEEP DISORDER  1  1/13 (7.69%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  1/13 (7.69%)  0/5 (0.00%) 
DYSPNOEA  1  1/13 (7.69%)  0/5 (0.00%) 
OROPHARYNGEAL PAIN  1  1/13 (7.69%)  0/5 (0.00%) 
PRODUCTIVE COUGH  1  1/13 (7.69%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders     
DERMATITIS CONTACT  1  1/13 (7.69%)  0/5 (0.00%) 
HYPERHIDROSIS  1  1/13 (7.69%)  0/5 (0.00%) 
PRURITUS  1  2/13 (15.38%)  1/5 (20.00%) 
RASH  1  1/13 (7.69%)  0/5 (0.00%) 
SWELLING FACE  1  1/13 (7.69%)  0/5 (0.00%) 
Vascular disorders     
HYPERTENSION  1  2/13 (15.38%)  1/5 (20.00%) 
HYPOTENSION  1  1/13 (7.69%)  0/5 (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: NCT02487199    
Other Study ID Numbers: M15-461
2015-002012-33 ( EudraCT Number )
First Submitted: June 29, 2015
First Posted: July 1, 2015
Results First Submitted: October 31, 2017
Results First Posted: December 4, 2017
Last Update Posted: December 4, 2017