Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is 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) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.
This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-450/r and ABT-072, plus ribavirin (RBV) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450 | Drug | tablets |
| |
| ABT-072 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). | Week 4 through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) | Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. | Week 2 |
| Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Cohen, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 41128 | Los Angeles | California | 90048 | United States | ||
| Site Reference ID/Investigator# 42262 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23439262 | Derived | Lawitz E, Poordad F, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. A phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1. J Hepatol. 2013 Jul;59(1):18-23. doi: 10.1016/j.jhep.2013.02.009. Epub 2013 Feb 22. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ABT-450/r and ABT-072, Plus Ribavirin (RBV) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
tablets |
|
| Ribavirin | Drug | tablets |
|
| Ritonavir | Drug | capsules |
|
|
Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). |
| Week 4 |
| Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 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. | Post-treatment Day 1 to Post-treatment Week 12 |
| Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment | 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. | Post-treatment Day 1 to Post-treatment Week 24 |
| Time to Failure to Suppress or Rebound During Treatment | 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. | Day 1 through Week 12 |
| Time to Virologic Relapse Through 24 Weeks Post-treatment | 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. | Post-treatment Day 1 to Post-treatment Week 24 |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Site Reference ID/Investigator# 41127 | San Antonio | Texas | 78215 | United States |
| Site Reference ID/Investigator# 43182 | Seattle | Washington | 98101 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Baseline analyses included all participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABT-450/r and ABT-072, Plus Ribavirin (RBV) | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Hepatitis C Virus (HCV) Genotype/ Subtype | Number | participants |
| |||||||||||||||||||||||
| Interleukin 28B (IL28B) Genotype | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). | 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. | Posted | Number | percentage of participants | Week 4 through Week 12 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) | Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. | Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures. | Posted | Number | percentage of participants | Week 2 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 | Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). | Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures. | Posted | Number | percentage of participants | Week 4 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 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. | Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures. | Posted | Number | percentage of participants | Post-treatment Day 1 to Post-treatment Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment | 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. | Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures. | Posted | Number | percentage of participants | Post-treatment Day 1 to Post-treatment Week 24 |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Failure to Suppress or Rebound During Treatment | 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. | Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). | Posted | Mean | Standard Error | Days | Day 1 through Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Virologic Relapse Through 24 Weeks Post-treatment | 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. | 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. | Posted | Mean | 95% Confidence Interval | Days | Post-treatment Day 1 to Post-treatment Week 24 |
|
|
Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks).
Serious Adverse Events were also collected from the time that informed consent was obtained until 30 days after last dose (64 weeks).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABT-450/r and ABT-072, Plus Ribavirin (RBV) | 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. | 0 | 11 | 11 | 11 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VERTIGO | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| FOOD POISONING | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| POST-TRAUMATIC PAIN | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| TENSION HEADACHE | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C585405 | paritaprevir |
| C000625346 | ABT-072 |
| D012254 | Ribavirin |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| TT |
|
| Missing |
|
|
|
|
|
|
|