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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-DAA + PegIFN/RBV | Experimental | 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 (Substudy 1) and followed by pegIFN and RBV alone for an additional 24 weeks (Substudy 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450/r | Drug | ABT-450 (tablets) dosed with ritonavir (capsules or tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Virologic Response 24 Weeks Post Treatment (SVR24) | 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). | 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 |
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Inclusion Criteria:
Main Inclusion: To be enrolled in this protocol, subjects must meet all of the following inclusion criteria:
Subjects diagnosed with cirrhosis must also meet the following criteria:
Exclusion Criteria:
Subjects with compensated cirrhosis must also not meet the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30858739 | Derived | Bernstein D, Tripathi R, Cohen DE. Ombitasvir, paritaprevir, and ritonavir with peginterferon-alpha2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection. Hepat Med. 2019 Feb 13;11:35-40. doi: 10.2147/HMER.S189158. eCollection 2019. |
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The study included a 42-day screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2-DAA + PegIFN/RBV | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 26, 2015 | Apr 16, 2018 |
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| ABT-267 | Drug | ABT-267 (tablets) |
|
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| pegylated interferon alpha-2a (pegIFN) | Drug | pegIFN alpha-2a (syringe) |
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| Ribavirin (RBV) | Drug | Ribavirin (tablets) |
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| Percentage of Participants With Extended Rapid Virologic Response (eRVR) | eRVR was defined as HCV RNA level < LLOQ at Substudy 1 treatment weeks 4 through 12 without a confirmed HCV RNA >= LLOQ | Treatment weeks 4 through 12 of Substudy 1 (DAAs plus pegIFN alpha-2a and RBV) |
| Number of Participants With Adverse Events | 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. | 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). |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2-DAA + PegIFN/RBV | 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. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 Achieving Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | 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). | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 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 |
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| Secondary | Percentage of Participants Achieving Virologic Response 24 Weeks Post Treatment (SVR24) | 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). | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 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 |
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| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | eRVR was defined as HCV RNA level < LLOQ at Substudy 1 treatment weeks 4 through 12 without a confirmed HCV RNA >= LLOQ | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Treatment weeks 4 through 12 of Substudy 1 (DAAs plus pegIFN alpha-2a and RBV) |
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| Secondary | Number of Participants With Adverse Events | 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. | Safety population (all subjects who received at least 1 dose of study drug) | Posted | Number | participants | 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). |
|
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).
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2-DAA + PegIFN/RBV | 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. | 1 | 32 | 1 | 32 | 28 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| VISION BLURRED | Eye disorders | MedDRA 19.0 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| ANAL PRURITUS | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 19.0 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA 19.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 19.0 | Systematic Assessment |
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| FEELING ABNORMAL | General disorders | MedDRA 19.0 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 19.0 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 19.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 19.0 | Systematic Assessment |
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| JAUNDICE | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 19.0 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA 19.0 | Systematic Assessment |
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| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 19.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| IRRITABILITY | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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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 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2017 | Apr 16, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| 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 |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C585405 | paritaprevir |
| D019438 | Ritonavir |
| C586094 | ombitasvir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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