Register of Telaprevir and Boceprevir in Routine Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02004379

Enrollment

1553

Registered

2013-12-09

Start date

2013-11-30

Completion date

2015-06-30

Last updated

2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

HCV, Hepatitis C, telaprevir, boceprevir, clinical practice

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

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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	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	12 months	Number and frequencies of serious adverse event (SAE) during the treatment

Countries

Spain

Outcome results