Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

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: NCT01221298
Recruitment Status : Completed
First Posted : October 15, 2010
Results First Posted : January 8, 2015
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C
HCV
Chronic Hepatitis C Infection
Hepatitis C Genotype 1
Interventions Drug: ABT-450
Drug: ABT-072
Drug: Ribavirin
Drug: Ritonavir
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Hide Arm/Group Description ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Period Title: Overall Study
Started 11
Completed 11 [1]
Not Completed 0
[1]
The number of participants who completed study drug
Arm/Group Title ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Hide Arm/Group Description ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
Baseline analyses included all participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
56.4  (7.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
3
  27.3%
Male
8
  72.7%
Hepatitis C Virus (HCV) Genotype/ Subtype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
1A 8
1B 3
Interleukin 28B (IL28B) Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
CC 11
CT 0
TT 0
Missing 0
1.Primary Outcome
Title Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12
Hide Description Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).
Time Frame Week 4 through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
For the percentage of subjects with HCV RNA suppressed below the LLOQ from Week 4 through Week 12 out of all subjects dosed, it was assumed that if 60% of subjects were successfully suppressed from Week 4 through Week 12 then 20 subjects would give a 95% two-sided confidence interval of (36.1%, 80.9%) using binomial exact methods.
Arm/Group Title ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Hide Arm/Group Description:
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of participants
100
2.Secondary Outcome
Title Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
Hide Description Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.
Arm/Group Title ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Hide Arm/Group Description:
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of participants
100
3.Secondary Outcome
Title Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4
Hide Description Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.
Arm/Group Title ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Hide Arm/Group Description:
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of participants
100
4.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Hide Description Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.
Time Frame Post-treatment Day 1 to Post-treatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.
Arm/Group Title ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Hide Arm/Group Description:
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of participants
90.9
5.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
Hide Description Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.
Time Frame Post-treatment Day 1 to Post-treatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.
Arm/Group Title ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Hide Arm/Group Description:
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of participants
90.9
6.Secondary Outcome
Title Time to Failure to Suppress or Rebound During Treatment
Hide Description The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA <LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of detection (LLOD) for participants who previously achieved HCV RNA < LLOD.
Time Frame Day 1 through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Arm/Group Title ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Hide Arm/Group Description:
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Overall Number of Participants Analyzed 11
Mean (Standard Error)
Unit of Measure: Days
NA [1]   (NA)
[1]
The time to failure to suppress or rebound during treatment could not be estimated, as no participant met failure to suppress or rebound criteria.
7.Secondary Outcome
Title Time to Virologic Relapse Through 24 Weeks Post-treatment
Hide Description Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.
Time Frame Post-treatment Day 1 to Post-treatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.
Arm/Group Title ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Hide Arm/Group Description:
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Overall Number of Participants Analyzed 11
Mean (95% Confidence Interval)
Unit of Measure: Days
84 [1] 
(NA to NA)
[1]
Cannot be estimated as only one participant relapsed.
Time Frame Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks).
Adverse Event Reporting Description Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
 
Arm/Group Title ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Hide Arm/Group Description ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
All-Cause Mortality
ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Affected / at Risk (%)
Total   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ABT-450/r and ABT-072, Plus Ribavirin (RBV)
Affected / at Risk (%)
Total   11/11 (100.00%) 
Ear and labyrinth disorders   
VERTIGO  1  1/11 (9.09%) 
Eye disorders   
VISUAL ACUITY REDUCED  1  1/11 (9.09%) 
Gastrointestinal disorders   
ABDOMINAL DISCOMFORT  1  1/11 (9.09%) 
ABDOMINAL PAIN  1  1/11 (9.09%) 
ABDOMINAL PAIN UPPER  1  1/11 (9.09%) 
DIARRHOEA  1  1/11 (9.09%) 
DYSPEPSIA  1  1/11 (9.09%) 
FOOD POISONING  1  1/11 (9.09%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  2/11 (18.18%) 
NAUSEA  1  3/11 (27.27%) 
VOMITING  1  1/11 (9.09%) 
General disorders   
FATIGUE  1  3/11 (27.27%) 
INFLUENZA LIKE ILLNESS  1  1/11 (9.09%) 
Infections and infestations   
OTITIS MEDIA  1  1/11 (9.09%) 
Injury, poisoning and procedural complications   
POST-TRAUMATIC PAIN  1  1/11 (9.09%) 
Metabolism and nutrition disorders   
DIABETES MELLITUS  1  1/11 (9.09%) 
GOUT  1  1/11 (9.09%) 
Nervous system disorders   
DIZZINESS  1  1/11 (9.09%) 
DYSGEUSIA  1  1/11 (9.09%) 
HEADACHE  1  4/11 (36.36%) 
TENSION HEADACHE  1  1/11 (9.09%) 
Psychiatric disorders   
ANXIETY  1  1/11 (9.09%) 
INSOMNIA  1  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA  1  1/11 (9.09%) 
NASAL CONGESTION  1  1/11 (9.09%) 
Skin and subcutaneous tissue disorders   
DRY SKIN  1  3/11 (27.27%) 
ECZEMA  1  1/11 (9.09%) 
PRURITUS GENERALISED  1  1/11 (9.09%) 
RASH  1  2/11 (18.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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 ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01221298    
Other Study ID Numbers: M12-267
First Submitted: October 13, 2010
First Posted: October 15, 2010
Results First Submitted: December 29, 2014
Results First Posted: January 8, 2015
Last Update Posted: January 8, 2015