Chronic Hepatitis C, Genotype 1 or 4 Clinical Trial
Official title:
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium
| NCT number | NCT02581163 |
| Other study ID # | P15-650 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 7, 2015 |
| Est. completion date | February 12, 2018 |
| Verified date | January 2019 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Belgium in a clinical practice patient population.
| Status | Completed |
| Enrollment | 314 |
| Est. completion date | February 12, 2018 |
| Est. primary completion date | February 12, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label - If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy) - Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study - Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial Exclusion Criteria: • None |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie | IST GmbH, Germany |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria: evaluable HCV RNA data =70 days after the last actual dose of the ABBVIE REGIMEN an HCV RNA value =50 IU/mL at the last measurement post-baseline HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement =70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure |
12 weeks after the last actual dose of study drug | |
| Secondary | Percentage of Participants With Virologic Response at End of Treatment (EoT) | Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. | Up to 24 weeks | |
| Secondary | Percentage of Participants With Relapse | Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. | Up to 48 weeks after the last actual dose of study drug | |
| Secondary | Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. | Up to 24 weeks | |
| Secondary | Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). | 12 weeks after the last actual dose of study drug | |
| Secondary | Percentage of Participants Meeting Relapse Criteria | Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. | 12 weeks after the last actual dose of study drug | |
| Secondary | Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria | Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. | 12 weeks after the last actual dose of study drug | |
| Secondary | Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria | The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. | 12 weeks after the last actual dose of study drug |