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This prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA [direct-acting antiviral agent] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of participants with chronic hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in Russia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir | Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer a patient the opportunity to participate in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. | 12 weeks after the last dose of study drug (week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Virological Response at End of Treatment (EoT) | Virological response is defined as HCV RNA less than 50 IU/mL. | End of treatment, maximum of 12 weeks |
| Percentage of Participants With Relapse |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with chronic hepatitis C (CHC) genotype 1 (GT1b) and compensated liver cirrhosis will be recruited and observed in approximately 5-7 national and regional hospitals/outpatient services in Russia.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South-Ural State Med. Academy | Chelyabinsk | 454052 | Russia | |||
| KOGBUZ Kirovsk Infect Hosp |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 60 participants signed the written patient authorization form and were enrolled into the study in 7 investigational sites located in Russia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir | Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3 direct-acting antiviral agent [3DAA] ABBVIE REGIMEN) for 12 weeks. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer a patient the opportunity to participate in this study. |
| 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 | Nov 29, 2016 | Nov 15, 2018 |
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Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.
| End of treatment (week 12) and up to 12 weeks after the end of treatment. |
| Percentage of Participants With Breakthrough | Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. | 12 weeks |
| Percentage of Participants With Failure to Suppress | Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. | 12 weeks |
| Percentage of Participants With Missing SVR12 Data | 12 weeks after the last dose of study drug (week 24) |
| Kirov |
| 610008 |
| Russia |
| Specialized Clinical Infectiou | Krasnodar | 350000 | Russia |
| Orenburg Regional Clinical Hos | Orenburg | 460018 | Russia |
| LLC Medical Company | Samara | 443063 | Russia |
| GBOU VPO Saratov state Med Uni | Saratov | 410012 | Russia |
| Ulyanovsk Regional Clin Hosp | Ulyanovsk | 432018 | Russia |
| COMPLETED |
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| NOT COMPLETED |
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The Core Population included all participants who had started and received the treatment combination recommended in the current local label for their disease characteristic and with end of treatment (EoT) > study day 55 (8 weeks).
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| ID | Title | Description |
|---|---|---|
| BG000 | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir | Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) 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 |
| ||||||||||||||||||
| Race/Ethnicity, Customized | 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 Virological Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. | Core population | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last dose of study drug (week 24) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Virological Response at End of Treatment (EoT) | Virological response is defined as HCV RNA less than 50 IU/mL. | Core population | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, maximum of 12 weeks |
|
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| Secondary | Percentage of Participants With Relapse | Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment. | Core population | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment (week 12) and up to 12 weeks after the end of treatment. |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Breakthrough | Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. | Core population | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Failure to Suppress | Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. | Core population | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks |
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| Secondary | Percentage of Participants With Missing SVR12 Data | Core population | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last dose of study drug (week 24) |
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From first dose of the 3DAA ABBVIE REGIMEN through 30 days after last dose (up to 16 weeks).
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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 | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir | Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks. | 0 | 60 | 1 | 60 | 1 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascariasis | Infections and infestations | MedDRA 20.1 | 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 | Mar 16, 2018 | Nov 15, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D005355 | Fibrosis |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| 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 |
| 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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