Ribavirin Bioavailability After Telaprevir Exposure

Hepatitis C Clinical Trial

Official title:

Ribavirin Bioavailability After Telaprevir Exposure in Hepatitis C Patients Treated With PEGylated -Interferon/Ribavirin/Telaprevir Triple Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881034
• Other study ID #: 69HCL16_0557
• Status: Completed
• Phase: N/A
• First received: August 18, 2016
• Last updated: August 26, 2016
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial Summary

Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with hepatitis C virus infection

• Previous non-response to pegylated-interferon/ribavirin therapy

• Re-treatment with pegylated-interferon/ribavirin and telaprevir

Exclusion Criteria:

• Decompensated liver cirrhosis

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Triple therapy

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy	Plasma ribavirin trough concentrations were measured using a validated high-performance liquid chromatography-diode array detector method, a highly specific, sensible, and precise method of quantification	before telaprevir initiation during the previous course of PEG (pegylated)-IFN (interferon)/ribavirin combination therapy (T-1), and during the early phase (week 4 ± 2 weeks) of therapy	No
Secondary	Change in renal function between baseline and week 4 of triple therapy	Renal function was assessed with the commonly used Modification of the Diet in Renal Disease (MDRD) study equation which allows to assess the estimated glomerular filtration rate (eGFR).	Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of therapy	No
Secondary	Ribavirin plasma trough concentration at week 8 of therapy		at the later phase of therapy (Week 8 ± 2 weeks)	No
Secondary	Ribavirin plasma trough concentration after telaprevir withdrawal		after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))	No
Secondary	Renal function at week 8 of therapy		at the later phase of therapy (Week 8 ± 2 weeks)	No
Secondary	Renal function after telaprevir withdrawal		after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))	No