Evaluation of RIBAvirin Plasma COncentrations in Patients With Chronic Hepatitis C Infection Routinely Treated With Modern DAA Regimens

NCT02505243 | Completed

• 1 other identifier: UMCN-AKF-15.03
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate RBV plasma concentrations when used in combination with newly developed DAA combinations. If possible, its correlations with SVR rates and incidence of anaemia will be assessed in HCV-patients.

Conditions

HCV Coinfection; Hepatitis C

Keywords

ribavirin; direct-acting antivirals; pharmacokinetics; therapeutic drug monitoring

Outcome Measures

Primary Outcomes (1)

• Ribavirin concentration

  Analysis ribavirin concentration in plasma

  Ribavirin concentraition at week 8 of treatment

Secondary Outcomes (3)

• Sustained virological response (SVR12)

  Change from baseline virological resonse, 12 weeks after treatment.

• Hemoglobin concentrations

  Change from baseline hemoglobin concentrationes, 8 weeks after treatment.

• Ribavirin concentration

  Ribavirin concentraition at week 2 of treatment

Study Arms (1)

HCV patients

HCV patients treated with direct acting antivirals and ribavirin

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

chronicHCV infected patients treated with direct acting antivirals (daclatasvir, simeprevir, sofosbuvir, paritaprevir, ombitasvir, dasabuvir, ledipasvir) and ribavirin.

You may qualify if:

• HCV-infected patients
• Patient must be treated with ribavirin. The dosage of ribavirin may vary, as the different centers have different protocols for RBV dosing.
• Patient must be treated with one or more DAAs (simeprevir, sofosbuvir, daclatasvir, ledipasvir, paritaprevir, ombitasvir, or dasabuvir).
• At least 18 years of age at start of treatment.

You may not qualify if:

• None

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Erasmus Medical Center: collaborator
• University Medical Center Groningen: collaborator
• UMC Utrecht: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (1)

Radboud University Medical Centre

Nijmegen, Gelderland, Netherlands

Location

Related Publications (1)

• van Tilborg M, Lieveld FI, Smolders EJ, van Erpecum KJ, de Kanter CTMM, Maan R, van der Valk M, Arends JE, Dofferhoff ASM, Blokzijl H, Bijmolen M, Drenth JPH, de Knegt RJ, Burger DM; HepNed Study Group. Ribavirin steady-state plasma level is a predictor of sustained virological response in hepatitis C-infected patients treated with direct-acting antivirals. Aliment Pharmacol Ther. 2017 Nov;46(9):864-872. doi: 10.1111/apt.14288. Epub 2017 Sep 7.

  PMID: 28881031 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Hepatitis C

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

Study Officials

• David Burder, PharmdD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 22, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

NL (1)