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Register of Telaprevir and Boceprevir in Routine Clinical Practice

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ClinicalTrials.gov Identifier: NCT02004379
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )

Tracking Information
First Submitted Date November 20, 2013
First Posted Date December 9, 2013
Last Update Posted Date July 15, 2015
Study Start Date November 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 3, 2013)
  • Effectiveness of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated [ Time Frame: 12 months ]
    Know through routine clinical practice the percentage of patients who have negative VHC-ARN
  • Safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated [ Time Frame: 12 months ]
    Number and frequencies of serious adverse event (SAE) during the treatment
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02004379 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Register of Telaprevir and Boceprevir in Routine Clinical Practice
Official Title Not Provided
Brief Summary Know through routine clinical practice the effectiveness and safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with chronic hepatitis C, genotype 1, who are elegible to be treated with telaprevir or boceprevir
Condition Hepatitis C
Intervention Not Provided
Study Groups/Cohorts Patients with hepatitis C, genotype 1
Patients with hepatitis C, genotype 1, treated with telaprevir or boceprevir
Publications * Salmerón J, Vinaixa C, Berenguer R, Pascasio JM, Sánchez Ruano JJ, Serra MÁ, Gila A, Diago M, Romero-Gómez M, Navarro JM, Testillano M, Fernández C, Espinosa D, Carmona I, Pons JA, Jorquera F, Rodriguez FJ, Pérez R, Montero JL, Granados R, Fernández M, Martín AB, Muñoz de Rueda P, Quiles R; Alhambra Spanish Study Group. Effectiveness and safety of first-generation protease inhibitors in clinical practice: Hepatitis C virus patients with advanced fibrosis. World J Gastroenterol. 2015 Aug 14;21(30):9163-74. doi: 10.3748/wjg.v21.i30.9163.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 3, 2013)
1553
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients infected by hepatitis C virus, genotype 1
  • Indication of treatment with telaprevir or boceprevir in F3 and F4 fibrosis

Exclusion Criteria:

  • Being taking part in other
  • Inability to follow a monitoring
  • Contra-indications on triple therapy
  • Coinfected with HIV and HBV (hepatitis B virus)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02004379
Other Study ID Numbers FPS-TEL-2013-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )
Study Sponsor Fundación Pública Andaluza Progreso y Salud
Collaborators Not Provided
Investigators
Principal Investigator: Javier Salmerón Escobar Hospital Universitario de San Cecilio
PRS Account Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Verification Date July 2015