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Trial record 26 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study

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ClinicalTrials.gov Identifier: NCT01609933
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: ABT-450/r
Drug: ABT-267
Drug: pegylated interferon alpha-2a (pegIFN)
Drug: Ribavirin (RBV)
Enrollment 32
Recruitment Details  
Pre-assignment Details The study included a 42-day screening period.
Arm/Group Title 2-DAA + PegIFN/RBV
Hide Arm/Group Description 2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
Period Title: Overall Study
Started 32
Completed 28
Not Completed 4
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             3
Arm/Group Title 2-DAA + PegIFN/RBV
Hide Arm/Group Description 2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
All subjects who received at least 1 dose of study drug were included in the intent-to-treat (ITT) population; the safety population is the same as the ITT population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
51.4  (9.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
7
  21.9%
Male
25
  78.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   6.3%
White
30
  93.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Hide Description SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than lower limit of quantitation [LLOQ] 12 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).
Time Frame 12 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 36 weeks after subject’s initial dose of study drug in Substudy 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title 2-DAA + PegIFN/RBV
Hide Arm/Group Description:
2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks followed by pegIFN and RBV alone for an additional 24 weeks.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.3
(64.7 to 91.1)
2.Secondary Outcome
Title Percentage of Participants Achieving Virologic Response 24 Weeks Post Treatment (SVR24)
Hide Description SVR24 was defined as HCV RNA level less than the LLOQ 24 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).
Time Frame 24 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 48 weeks after subject’s initial dose of study drug in Substudy 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title 2-DAA + PegIFN/RBV
Hide Arm/Group Description:
2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.1
(61.2 to 89.0)
3.Secondary Outcome
Title Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Hide Description eRVR was defined as HCV RNA level < LLOQ at Substudy 1 treatment weeks 4 through 12 without a confirmed HCV RNA >= LLOQ
Time Frame Treatment weeks 4 through 12 of Substudy 1 (DAAs plus pegIFN alpha-2a and RBV)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 2-DAA + PegIFN/RBV
Hide Arm/Group Description:
2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.5
(71.9 to 95.0)
4.Secondary 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 probably related, possibly related, probably not related or not related. 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 after initiation of study drug through 30 days post-DAA dosing. For more details on AEs, see the AE section.
Time Frame From first dose of study drug through 30 days after last dose of study drug (DAAs plus pegIFN alpha-2a and RBV) (up to 28 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (all subjects who received at least 1 dose of study drug)
Arm/Group Title 2-DAA + PegIFN/RBV
Hide Arm/Group Description:
2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID).
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
2-DAA TEAE 29
2-DAA TESAE 1
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug through 30 days after the last dose of DAA (2-DAA + pegIFN alpha-2a and RBV) dosing (up to 28 weeks).
Adverse Event Reporting Description TEAEs and TESAEs are defined as any AE with an onset date that is after the first dose of study drug through 30 days after the last dose of DAAs (up to 28 weeks) and were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title 2-DAA + PegIFN/RBV
Hide Arm/Group Description 2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks and followed by pegIFN and RBV alone for an additional 24 weeks.
All-Cause Mortality
2-DAA + PegIFN/RBV
Affected / at Risk (%)
Total   1/32 (3.13%)    
Show Serious Adverse Events Hide Serious Adverse Events
2-DAA + PegIFN/RBV
Affected / at Risk (%) # Events
Total   1/32 (3.13%)    
Cardiac disorders   
MYOCARDIAL INFARCTION  1  1/32 (3.13%)  1
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2-DAA + PegIFN/RBV
Affected / at Risk (%) # Events
Total   28/32 (87.50%)    
Blood and lymphatic system disorders   
LYMPHOPENIA  1  2/32 (6.25%)  2
NEUTROPENIA  1  7/32 (21.88%)  10
Eye disorders   
VISION BLURRED  1  2/32 (6.25%)  3
Gastrointestinal disorders   
ABDOMINAL PAIN UPPER  1  3/32 (9.38%)  3
ANAL PRURITUS  1  2/32 (6.25%)  2
DIARRHOEA  1  6/32 (18.75%)  7
DRY MOUTH  1  2/32 (6.25%)  2
NAUSEA  1  9/32 (28.13%)  9
General disorders   
ASTHENIA  1  2/32 (6.25%)  2
CHILLS  1  3/32 (9.38%)  3
FATIGUE  1  11/32 (34.38%)  13
FEELING ABNORMAL  1  2/32 (6.25%)  2
INFLUENZA LIKE ILLNESS  1  6/32 (18.75%)  6
PAIN  1  3/32 (9.38%)  4
PYREXIA  1  4/32 (12.50%)  4
Hepatobiliary disorders   
JAUNDICE  1  2/32 (6.25%)  2
Infections and infestations   
BRONCHITIS  1  2/32 (6.25%)  3
UPPER RESPIRATORY TRACT INFECTION  1  3/32 (9.38%)  3
VIRAL INFECTION  1  2/32 (6.25%)  2
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  2/32 (6.25%)  2
Investigations   
NEUTROPHIL COUNT DECREASED  1  3/32 (9.38%)  7
WEIGHT DECREASED  1  2/32 (6.25%)  2
WHITE BLOOD CELL COUNT DECREASED  1  5/32 (15.63%)  7
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  2/32 (6.25%)  2
BACK PAIN  1  3/32 (9.38%)  4
MUSCLE SPASMS  1  2/32 (6.25%)  2
MYALGIA  1  2/32 (6.25%)  2
Nervous system disorders   
DISTURBANCE IN ATTENTION  1  3/32 (9.38%)  3
HEADACHE  1  14/32 (43.75%)  27
Psychiatric disorders   
ANXIETY  1  2/32 (6.25%)  2
DEPRESSION  1  2/32 (6.25%)  2
INSOMNIA  1  8/32 (25.00%)  10
IRRITABILITY  1  4/32 (12.50%)  4
Respiratory, thoracic and mediastinal disorders   
COUGH  1  4/32 (12.50%)  4
DYSPNOEA  1  4/32 (12.50%)  4
Skin and subcutaneous tissue disorders   
DRY SKIN  1  4/32 (12.50%)  6
PRURITUS  1  6/32 (18.75%)  8
RASH  1  8/32 (25.00%)  9
1
Term from vocabulary, MedDRA 19.0
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 ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01609933     History of Changes
Other Study ID Numbers: M13-101
First Submitted: May 30, 2012
First Posted: June 1, 2012
Results First Submitted: March 28, 2018
Results First Posted: June 19, 2018
Last Update Posted: June 19, 2018