Ribavirin Bioavailability After Telaprevir Exposure

NCT02881034 | Completed

• 1 other identifier: 69HCL16_0557
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C

Keywords

Anemia; Antiviral Agents; Glomerular Filtration Rate; Hepatitis C; Ribavirin; Telaprevir

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change in renal function between baseline and week 4 of triple therapy

  Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of therapy

• Ribavirin plasma trough concentration at week 8 of therapy

  at the later phase of therapy (Week 8 ± 2 weeks)

• Ribavirin plasma trough concentration after telaprevir withdrawal

  after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))

• Renal function at week 8 of therapy

  at the later phase of therapy (Week 8 ± 2 weeks)

• Renal function after telaprevir withdrawal

  after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))

Study Arms (1)

Hepatitis C patients

Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir

Drug: Triple therapy

Interventions

Triple therapy DRUG

Hepatitis C patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir

You may qualify if:

• Patients with hepatitis C virus infection
• Previous non-response to pegylated-interferon/ribavirin therapy
• Re-treatment with pegylated-interferon/ribavirin and telaprevir

You may not qualify if:

• Decompensated liver cirrhosis

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix Rousse

Lyon, France

Location

MeSH Terms

Conditions

Hepatitis C; Anemia

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 26, 2016
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 29, 2016

Record last verified: 2016-08

Locations

FR (1)