Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003738-18 | EudraCT Number |
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 and antiviral activity of 3 direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267; ABT-267 also known as ombitasvir] and ABT-333 [also known as dasabuvir]) plus ribavirin (RBV) compared with telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).
A randomized, open-label, parallel-arm, multicenter study to evaluate the safety and antiviral activity of the 3-DAA regimen (ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267] and ABT-333) plus ribavirin (3-DAA/RBV) compared with the combination of telaprevir (TPV) with RBV and pegIFN (TPV/RBV) in noncirrhotic participants with chronic hepatitis C virus genotype 1 (HCV GT1) infection who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).
Participants were randomized in a 2:1 ratio to receive 3-DAA/RBV (ABT-450/r/ABT-267 and ABT-333 plus RBV for 12 weeks) or TPV/RBV (TPV co-administered with pegIFN and RBV for 12 weeks, followed by followed by pegIFN and RBV for either 12 or 36 weeks, per local prescribing information).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-DAA/RBV | Experimental | 3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
|
| TPV/RBV | Active Comparator | TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450/r/ABT-267, ABT-333 | Drug | Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. | 12 weeks after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2) | The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into an MCS score (from 0 to 100; a higher score indicates better mental function and well-being). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yan Luo, MD | AbbVie | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26321288 | Result | Dore GJ, Conway B, Luo Y, Janczewska E, Knysz B, Liu Y, Streinu-Cercel A, Caruntu FA, Curescu M, Skoien R, Ghesquiere W, Mazur W, Soza A, Fuster F, Greenbloom S, Motoc A, Arama V, Shaw D, Tornai I, Sasadeusz J, Dalgard O, Sullivan D, Liu X, Kapoor M, Campbell A, Podsadecki T. Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials. J Hepatol. 2016 Jan;64(1):19-28. doi: 10.1016/j.jhep.2015.08.015. Epub 2015 Aug 29. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
A total of 154 participants were randomized: 6 participants did not receive at least 1 dose of study drug and were excluded from the analyses; 148 participants received at least 1 dose and were included in the intent-to-treat (ITT) population.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 3-DAA/RBV | 3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| FG001 | TPV/RBV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ribavirin | Drug | Tablet |
|
| Pegylated Interferon a-2a (PegINF) | Drug | Pre-filled syringe |
|
| Telaprevir | Drug | Film-coated tablet |
|
| Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV) |
| Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2) | The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being). | Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV) |
| Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 24 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. | 24 weeks after the last dose of study drug |
| Percentage of Participants With Virologic Failure During Treatment | Virologic failure during treatment was defined as HCV ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (≥ LLOQ) after HCV RNA < LLOQ during treatment or confirmed HCV RNA ≥ LLOQ at the end of treatment. | Baseline to end of treatment (12 weeks for 3-DAA/RBV and 24 or 48 weeks for TPV/RBV) |
| Percentage of Participants With Virologic Relapse After Treatment | Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (\ | Between end of treatment (Week 12 for 3-DAA/RBV and Week 24 or 48 for TPV/RBV) and Post-treatment (up to Week 12 Post-treatment) |
TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least 1 dose of study drug (ITT population) were included in baseline analysis population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 3-DAA/RBV | 3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| BG001 | TPV/RBV | TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 Sustained Virologic Response 12 Weeks After Treatment | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. | ITT population: All randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | 12 weeks after the last dose of study drug |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2) | The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into an MCS score (from 0 to 100; a higher score indicates better mental function and well-being). | All participants in the ITT population with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2) | The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being). | All participants in the ITT population with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 24 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. | All participants in the ITT population with evaluable data. | Posted | Number | percentage of participants | 24 weeks after the last dose of study drug |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure During Treatment | Virologic failure during treatment was defined as HCV ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (≥ LLOQ) after HCV RNA < LLOQ during treatment or confirmed HCV RNA ≥ LLOQ at the end of treatment. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to end of treatment (12 weeks for 3-DAA/RBV and 24 or 48 weeks for TPV/RBV) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Relapse After Treatment | Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (\ | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Between end of treatment (Week 12 for 3-DAA/RBV and Week 24 or 48 for TPV/RBV) and Post-treatment (up to Week 12 Post-treatment) |
|
|
AEs were collected from the time of study drug administration to 30 days after last dose of study drug (up to 52 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (total up to 101 weeks).
AEs were collected from first dose to 30 days after last dose (16 weeks for 12-week treatment, 28 weeks for 24-week treatment, 52 weeks for 48-week treatment); SAEs were collected from the time that informed consent was obtained to end of study (up to 65 weeks for 12-week treatment, 77 weeks for 24-week treatment, 101 weeks for 48-week treatment).
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 | 3-DAA/RBV | 3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | 1 | 101 | 54 | 101 | ||
| EG001 | TPV/RBV | TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information. | 5 | 47 | 43 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| INJECTION SITE PHLEBITIS | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| DIARRHOEA INFECTIOUS | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ANAL PRURITUS | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| APHTHOUS STOMATITIS | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| DEPRESSED MOOD | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| IRRITABILITY | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 17.0 | 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 Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| 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 |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C588260 | dasabuvir |
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| C000607373 | Viekira Pak |
| D012254 | Ribavirin |
| C486464 | telaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
| Participants |
|
|