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Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Romania

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ClinicalTrials.gov Identifier: NCT02807402
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : August 15, 2017
Sponsor:
Collaborator:
IST GmbH, Germany
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Romania

Condition or disease
Chronic Hepatitis C

Study Type : Observational
Actual Enrollment : 522 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Romania
Study Start Date : July 14, 2016
Actual Primary Completion Date : August 3, 2017
Actual Study Completion Date : August 3, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with chronic infection of HCV Genotype 1 (GT1)
Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1 , receiving combination therapy with the interferon-free ABBVIE REGIMEN± RBV according to standard of care and in line with the current local label



Primary Outcome Measures :
  1. Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12) [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]
    SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug


Secondary Outcome Measures :
  1. Usage pattern of treatment regimen in Romania [ Time Frame: Up to 48 weeks ]
    Evaluate the usage pattern of treatment regimen type (± Dasabuvir, ± RBV, intended and actual combination, dose and duration) in the Romanian population

  2. Percentage of the direct-acting antiviral (DAA) dose taken in relation to the target dose of DAA [ Time Frame: Up to 48 weeks ]
  3. Percentage of the Ribavirin (RBV) dose taken in relation to the target dose of RBV [ Time Frame: Up to 48 weeks ]
  4. Percentage of missed Ribavirin (RBV) treatment days in relation to the target number of RBV treatment days [ Time Frame: Up to 48 weeks ]
  5. Number of participants with concomitant medications [ Time Frame: Up to 48 weeks ]
  6. Number of participants with co-morbidities [ Time Frame: Up to 48 weeks ]
  7. Change in participants workability measured with the Work Productivity and Activity Impairment (WPAI):Hepatitis C questionnaire [ Time Frame: Up to 48 weeks ]
  8. Change in participants quality of life measured with the EuroQol 5 dimension 5 level (EQ-5D-5L) questionnaire [ Time Frame: Up to 48 weeks ]
  9. Change of participant activation with the Patient activation Measure (PAM-13) questionnaire [ Time Frame: Up to 48 weeks ]
  10. The percentage of participants with virological response at end of treatment (EoT). [ Time Frame: Up to EoT, maximum of 24 weeks ]
    Virological response defined as HCV RNA level less than 50 IU/mL.

  11. The percentage of participants with relapse at EoT [ Time Frame: Up to EoT, maximum of 24 weeks ]
    Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL.

  12. The percentage of participants with breakthrough. [ Time Frame: Up to EoT, maximum of 24 weeks ]
    Breakthrough defined as at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment

  13. The percentage of participants meeting on-treatment virologic failure. [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]

    On-treatment virologic failure defined as breakthrough (at least

    1 documented 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)


  14. The number of participants meeting premature study drug discontinuation. [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]
    Defined as participants who prematurely discontinued study drug and who experienced no on-treatment virologic failure.

  15. The percentage of participants meeting missing SVR12 data and/or none of the above criteria. [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic infection of HCV Genotype 1 (GT1)
Criteria

Inclusion Criteria:

Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1 , receiving combination therapy with the interferon-free ABBVIE REGIMEN± RBV according to standard of care and in line with the current local label

If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)

Patients must voluntarily sign and date a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study

Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807402


Locations
Romania
Brasov County Clinical Emergency Hospital /ID# 154186
Brasov, Romania
Brasov Infectious Diseases Hospital /ID# 154188
Brasov, Romania
National Institute of Infectious Diseases "Matei Bals" /ID# 152376
Bucharest, Romania, 21105
National Institute of Infectious Diseases "Matei Bals" /ID# 152385
Bucharest, Romania, 21105
National Institute of Infectious Diseases "Matei Bals" /ID# 152386
Bucharest, Romania, 21105
National Institute of Infectious Diseases "Matei Bals" /ID# 152390
Bucharest, Romania, 21105
National Institute of Infectious Diseases "Matei Bals" /ID# 154187
Bucharest, Romania, 21105
Institutul Clinic Fundeni /ID# 152387
Bucharest, Romania, 22328
Institutul Clinic Fundeni /ID# 152388
Bucharest, Romania, 22328
Institutul Clinic Fundeni /ID# 153377
Bucharest, Romania, 22328
Clinical Hospital of Infectious Diseases and Pneumoftisiolog /ID# 152367
Bucharest, Romania, 30223
Clinical Hospital of Infectious and Tropical Dis Victor Babe /ID# 152383
Bucharest, Romania, 30303
Clinical Hospital of Infectious and Tropical Dis Victor Babe /ID# 152389
Bucharest, Romania, 30303
Badea Medica Gastroenterology Clinic /ID# 152380
Cluj Napoca, Romania, 400375
Medical Center of Gastroenterology, Hepatology and Endoscopy /ID# 152382
Cluj Napoca, Romania, 410072
Constanta County Clinical Emergency Hospital /ID# 152368
Constanta, Romania, 900635
Constanta CF Clinical Hospital /ID# 152371
Constanta, Romania, 900697
Iasi Gastroenterology and Hepatology Institute /ID# 152378
Iasi, Romania, 700463
Iasi Gastroenterology and Hepatology Institute /ID# 152375
Iasi, Romania, 700506
Oradea County Clinical Emergency Hospital /ID# 152366
Oradea, Romania, 410167
Algomed Policlinic /ID# 152370
Timisoara, Romania, 300002
Timisoara County Clinical Emergency Hospital /ID# 152369
Timisoara, Romania, 300736
Sponsors and Collaborators
AbbVie
IST GmbH, Germany
Investigators
Study Director: Corina Ionescu, MD Abbvie Romania

Additional Information:
eCRF  This link exits the ClinicalTrials.gov site

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02807402     History of Changes
Other Study ID Numbers: P15-698
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017

Keywords provided by AbbVie:
Ombitasvir
Dasabuvir
Paritaprevir
HCV
Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents